1002-CL-0101: A Phase 1 Study of ASP1002 in participants with Metastatic or Locally Advanced Solid Tumors
Study Sponsor: Astellas Pharma Global Development, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase I
Purpose of study: This is a first-in-human study that is looking to study the safety, and tolerability to determine the maximum tolerated dose of study drug ASP1002. The study is open to multiple tumor types – NSCLC, US, CRC, prostate adenocarcinoma, ovarian, and triple negative breast cancer. It is made up of two parts – Part 1: Dose escalation, where the study will determine the highest dose tolerable, and Part 2: dose expansion, where the determined dose will be tested in the tumor types that had the best response to the study drug.
Inclusion Criteria
– Be 18 years or older at study start.
– Must have locally advanced or metastatic solid tumor as determined by pathology records or biopsy.
For dose escalation, patient must have one of the following tumor types: non small-cell lung cancer, urothelial carcinoma, colorectal cancer, prostate adenocarcinoma, epithelial ovarian cancer, or triple negative breast cancer.
For dose expansion, patient must have: NSCLC, UC, CRC, or any tumor type which had confirmed response observed during the dose escalation part.
– Has progressed on, is intolerant to, refused standard therapy, or there is no standard therapy that would provide clinical benefit. (No limit on prior number of lines of therapy)
– Patient has accessible archival tissue that is less than 6 months old from primary or metastatic site. Patients without available tissue will need to undergo biopsy, or if biopsy deemed unsafe, case may be discussed with the medical monitor. Additionally, will undergo an on-treatment biopsy.
– Must have at least 1 measurable lesion per RECIST 1.1
– Must have ECOG of 0 – 1.
– Must have completed previous radiotherapy at least 2 weeks prior to study start.
– Must have predicted life expectancy of at least 12 weeks per treating physician.
– Must have adequate organ function as determined by local lab tests, and lab values must be collected within 7 days prior to first dose.
– Female participant is not pregnant.
– Participants must agree to not breastfeed starting at screening, throughout the study, and for 90 days post last dose. Additionally, participants must agree to use highly effective forms of contraception and must not donate sperm from screening, while on study, and for 90 days post last dose.
– Must not participate in another interventional study while receiving ASP1002.
Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Weighs less than 40kg.
– Has grade 2 or higher toxicity per CTCAE that is due to prior therapies.
– Symptomatic central nervous system metastasis or uncontrolled CNS disease. (Patient with previously treated CNS mets may be eligible if they are clinically and radiologically stable for at least 4 weeks prior to study start, and are not currently on systemic steroids of 10mg prednisone or more per day)
– Patient has active autoimmune disease. Patients with type 1 diabetes, endocrinopathies, stable replacement therapy, or skin disorders such as alopecia, vitiligo, or psoriasis are allowed.
– Has myocardial infarct, or unstable angina within 6 months, or has symptomatic congestive heart failure or other clinically significant cardiac condition.
– Has QTcF of more than 470ms within 7 days of study start.
– LVEF< 45% per screening echocardiogram.
– Has known HIV infection. Patient is allowed if CD4+ T cell counts are equal to or greater than 350 cells/μL and patient has no history of AIDS defining opportunistic infections within the last 6 months.
– Positive serology testing.
– History of drug-induced pneumonitis, ILD, current pneumonitis, or prior history requiring high-dose glucocorticoids.
– Uncontrolled illness such as active infections, substance abuse or psychiatric illness, or social situations that would impact the patient’s ability to comply with study requirements.
– Prior bone marrow or solid organ transplant.
– Has had major surgery, and has not recovered, within 28 days prior to study start.
– Positive COVID-19 test within 10 days prior to study start.
– Has received any other investigational therapy, antineoplastic therapy, or immunotherapy within last 21 days.
– Requires or has received systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Patient has discontinued prior immunomodulatory therapy due to grade 3 or higher that was immune-related and deemed life-threatening by the treating physician.
– Has other active malignancy requiring therapy.
– Has received prior anti-CD137 therapy.
– Received a live vaccine within last 28 days prior to study start.
Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
AMG757: 20240092: A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects with Small Cell Lung Cancer (SCLC) (DeLLphi-309)
Study Sponsor: Amgen, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: This study is being done to learn more about tarlatamab in people with Small Cell Lung Cancer (SCLC); a type of fast-growing cancer that forms in tissues of the lung and can spread to other parts of the body) that has progressed following platinum-based chemotherapy (a type of cancer treatment that involves drugs containing platinum ion compounds). This cancer type may have an excess amount of protein markers (e.g., delta-like ligand 3 [DLL3]; a protein possibly causing cells to grow more quickly and multiply abnormally). This study is being done to see how well tarlatamab works and whether it causes any side effects. This study will also look at what doses of tarlatamab are safe for people to take.
Inclusion Criteria:
– Must be at least 18 years or older.
– Histologically or cytologically confirmed small cell lung cancer with demonstrated progression or relapse.
– Patient has progressed or recurred after 1 platinum-based treatment.
– Must have measurable disease per RECIST 1.1 within 21-day screening period.
– Must have an ECOG of 0 – 1.
– Minimum life expectancy of at least 12 weeks.
– Adequate organ function as determined by local lab tests.
Exclusion Criteria:
– Previous diagnosis or transformed non-small cell lung cancer, including EGFR mutation positive NSCLC that transformed to SCLC.
– Symptomatic brain metastases. (Some exceptions such as the following apply – subject is asymptomatic, had whole brain radiation or surgery at least 2 weeks prior to first dose, or stereotactic radiosurgery done at least 7 days prior to first dose, has clinically stable disease and off steroids for at least 5 days, is off of anti-epileptic drugs or on a stable dose of anti-epileptic drugs for at least 14 days prior to first dose of study treatment, subjects with untreated brain mets that are asymptimatic and do not require corticosteroids or local therapy).
– Has had history of other malignancy within the past 2 years (with following exceptions: malignancy treated with curative intent and no known disease present for 1 year before enrollment, adequately treated nonmelanoma skin cancer or lentigo maligna, adequately treated cervical carcinoma in situ, adequately treated breast ductal carcinoma in situ, prostatic intraepithelial neoplasia, adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ, all without evidence of disease).
– evidence of interstitial lung disease, or active non-infectious pneumonitis.
– diagnosis or evidence of leptomeningeal disease.
– active autoimmune disease requiring systemic treatment within the past 2 years, or other immunosuppressive therapy while on study (replacement therapy is allowed).
– Myocaridal infarct, or symptomatic congestive heart failure (NYHA > Class 2) within 6 months prior to first dose.
– History of arterial thrombosis (stroke, or ischemic attack) within 6 months prior to first dose.
– Presence or history of HIV infection (If undetectable viral load and on antiviral therapy, are permitted on study with regular monitoring).
– Active Hepatitis C or B infections (some exceptions may apply pending lab tests).
– Symptoms or clinical/radiographic signs of active or uncontrolled infection within 7 days prior to first dose.
– Prior history or severe or life-threatening events from immune-mediated therapy.
– Major surgery within 21 days prior to first dose.
Additional criteria may apply and will be discussed with the treating physician and study team.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
BNT 372-02: A Phase II, multi-site, randomized, open-label clinical trial to evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with chemotherapeutic agents as first- and second line treatment in triple-negative breast cancer
Study Sponsor: BioNTech SE
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: This study is looking to test the safety and effectiveness of study drug BNT327 (also called PM8002) in triple-negative breast cancer. The study drug is a bi-specific antibody, which means that the study drug consists of an antibody that specifically binds to two different target proteins. Antibodies are protective proteins produced by your immune system. The two target proteins are programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor A (VEGF-A). By blocking the function of these proteins, study drug could increase your body’s ability to fight infection and disease, reduce the blood supply in your tumor (and thus reduce tumor growth), and reduce or stop tumor spreading.
Inclusion Criteria:
– Must be at least 18 or older.
– Must provide fresh or archival tumor sample during screening period.
– Must have at least 1 measurable lesion per RECIST 1.1
– ECOG of 0-1
– Minimum life expectancy of more than 3 months.
– Must have adequate organ function per local lab tests.
– Must practice highly effective methods of contraception while on study and for 6 months after the last dose of study drug.
– Women of childbearing potential must not donate eggs until after 6 months after last dose. Men must agree not to donate sperm for the same.
Additional criteria may apply and will be discussed with the treating physician and study team.
Exclusion Criteria:
– Pregnant or breastfeeding or if planning to have children during trial or within 60 days after the last dose.
– Has medical, psychological or social condition that, in the opinion of the investigator would impact the patient’s ability to adhere to protocol and visit requirements.
– History of alcoholic abuse, psychotropic drug abuse, or illicit drug addiction.
– Have received any of the following therapies or drugs prior to initial treatment: prior treatment with PDL1/VEGF bispecific antibody.
– Received systemic anti-cancer therapy within 4-weeks prior to starting study drug, or has received palliative radiotherapy within 7 days prior to starting study.
– Received systemic immunosuppressive therapies within 5 weeks prior to starting study drug. Exceptions are local, intranasal, intra-ocular, intra-articular, or inhaled corticosteroids, short-term use (less than 7 days).
– Received systemic corticosteroids (dosage greater than 10mg/day of prednisone or equivalent) within 3 weeks prior to initiation of trial treatment.
– Live or attenuated vaccine within 4 weeks
– Received IV antibiotics within 3 weeks prior to study start.
– Use of any other investigational product within 4 weeks prior to starting study treatment, or is taking part in another investigational interventional clinical trial.
– Major organ surgery, significant trauma, invasive dental procedures within 28 days prior to study start.
– Received allogenic stem cell transplant or organ transplant.
– Brain mets (with certain exceptions, to be discussed with study team and physician).
– Autoimmune disease requiring systemic treatment.
– Other malignant tumors within 5 years prior to trial treatment.
– Significant heart conditions within 6 months prior to study start.
– Hypertension or diabetic condition prior to initiation of trial treatment.
– Serious non-healing wounds, ulcers, or bone fractures.
– Evidence of major coagulation disorders or other significant risks of hemorrhage such as intracranial or intraspinal hemorrhage, tumor lesions invading large blood vessels with risk of bleeding, thrombosis or embolism within 6 months prior to initiation of treatment, clinically significant hemoptysis or tumor hemorrhage within 1 month prior to initiation of trial treatment, anticoagulant therapy for therapeutic purposes within 14 days prior to study start, received anti-platelet drugs within 10 days prior to study start.
– Uncontrolled pleural, pericardial effusion, or ascites requiring recurrent draining.
– Hypersensitivity to trial treatment or active ingredients
– Has HIV or AIDS
– Know active or history of Hepatitis B or C must have viral load below the limit of quantification.
– Has superior vena cava syndrome or spinal cord compression.
– Have TB or history of TB not successfully treated
Additional criteria may apply and will be discussed with the treating physician and study team.
Study Contact:
Alissa Gavenda, RN, OCN
(952) 993-6705
alissa.gavenda@parknicollet.com
CanLab: Correlation of Cannabinoid Concentrations to Effective Dose from Patients Initiating Cannabis Consumption for Cancer Related Symptoms.
Study sponsor: HealthPartners Institute Cancer Research Center
Location: HealthPartners Frauenshuh Cancer Center
Phase of Study: Registry / Supportive Care
Purpose of study: The purpose of this study is to look at daily doses of THC and CBD, blood cannabis levels, and changes in patient-reported symptoms, in order to understand if certain dose levels lead to improved symptoms. By determining the appropriate dosages, this will in turn help patients and providers to choose doses that are safe, effective, and cost-efficient.
Inclusion Criteria:
– Adults (aged 18 or more at enrollment)
– Seen in HealthPartners CanCaRE clinic with a cancer diagnosis
– Cannabis-naïve (no cannabis use in past 3 months) with plans to initiate cannabis
– Must be willing to be registered in the Minnesota Medical Cannabis Program (MMCP) and follow all rules and requirements of the state program
– Must be willing to report baseline and required patient-reported outcomes
– Must agree to only use cannabis dispensed from the state’s approved dispensaries
Exclusion Criteria:
– Patients with a history of intolerance or hypersensitivity to cannabis (i.e., cannabis hyperemesis)
– Patients who are pregnant or breastfeeding or plan to become pregnant during the study period. Pregnancy test is not required during the screening period.
– Has any condition that in the opinion of the investigator might jeopardize the safety of the subject or interfere with protocol compliance
Study Contact:
Carly Selleck
(952) 993-6723
Carly.Selleck@ParkNicollet.com
DB1311-O-1001: A Study of DB-1311 in Advanced/Metastatic Solid Tumors
Study sponsor: Dualitybio Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This is a first-in-human study that is looking to test the safety and effectiveness of study drug DB-1311 in solid tumors. The study drug is an antibody-drug combination composed of an anti-B7-H3 antibody and P1021 (a topoisomerase I Inhibitor). It is thought that by interfering with the B7-H3 protein, this may inhibit the growth of cancer cells. P1021 works to promote cancer cell death by interrupting DNA replication. The thought is that combination of these will help target and help the body to destroy the tumor cells.
Inclusion Criteria:
– Must be 18 years or older.
– Confirmed advanced / metastatic solid tumor that progressed / relapsed on standard therapy.
– At least one measurable lesion per RECIST 1.1.
– Has life expectancy of at least 3 months.
– ECOG of 0 – 1.
– LVEF of at least 50%.
– Adequate organ function as determined by lab tests.
– Willing to provide existing tumor tissue samples or undergo fresh tumor biopsy for measurement of biomarkers.
– Male, and female subjects of childbearing potential must agree to highly effect methods of contraception.
– Male subjects must not freeze or donate sperm for at least 4 months after last dose of study drug. Female subjects must not donate, or retrieve ova from time of screening through at least 7 months after last dose of study drug.
Several other cohort specific criteria may apply for Phase 2a of the study depending on disease type.
Part 2a:
SCLC (Cohort 1) –
-Prior treatment with at least 1 platinum therapy for 2 cycles.
NSCLC (Cohort 2) –
-Has received treatment with platinum-based chemo, or anti-PD-1/PD-L1 therapy in advanced/metastatic setting. If patient has genomic mutations other than EGFR mutation, patient must also have been treated with at least 1 genotype-directed therapy.
ESCC (Cohort 3) –
-Received at least 1 prior therapy for unresectable disease.
CRPC (Cohort 4) –
-Progressive metastatic CRPC as defined by PCWG3 criteria.
-Has received prior docetaxel.
-Has received prior novel hormone therapy.
Melanoma (Cohort 5) –
-Confirmed Stage 3 or metastatic melanoma
-Must previously have been treated with PD-1 or PD-L1 inhibitor.
-If pt. has BRAF mutant melanoma, must have had prior treatment that included a BRAF gene or MEK inhibitor.
HCC (Cohort 6) –
-Confirmed HCC and has received 1 or 2 prior systemic regimens for metastatic disease.
-Has experienced progression during or after treatment with anti-PD-1/L1 agent given as monotherapy or combination.
Cervical Cancer (Cohort 7) –
-Recurrent or metastatic squamous cell, adenocarcinoma, or adenosquamous histology, and has experienced disease progression during or after treatment with standard of care platinum or doublet therapy.
Other Solid Tumors (Cohort 8) –
-Must have progressed after at least 1 prior standard therapy.
Additional criteria may apply and will be discussed with study team and physician.
Exclusion Criteria:
– Prior treatment with B7-H3 targeted therapy.
– Prior treatment with antibody drug conjugate with topoisomerase inhibitor (such as trastuzumab deruxtecan).
– Has medical history of symptomatic congestive heart failure NYHA class II-IV or serious cardiac arrhythmia requiring treatment.
– Medical history of myocardial infarct or unstable angina within 6 months prior to enrollment.
– Average QTcF > 470 based on ECG results.
– Unable or unwilling to discontinue concomitant medications that are known to prolong QT interval.
– Medical history of interstitial lung disease or has current interstitial lung disease.
– History of underlying pulmonary disorder (pulmonary emboli, severe asthma, COPD, restrictive lung disease, or other significant pulmonary disease that requires supplemental oxygen for treatment).
– Autoimmune, connective tissue, inflammatory disorder where there is suspicion of pulmonary involvement at screening.
– Uncontrolled infection requiring antibiotics, antivirals, or antifungals.
– Known HIV infection.
– Active hepatitis infection. Patients with history of, may be eligible after completing curative treatment, and have viral load below quantification limit.
– Lactating mother, or pregnant within 7 days prior to enrolling into the study.
– Spinal cord compressions or active nervous system metastases that requires corticosteroids. Patients with asymptomatic, radiologically and neurologically stable disease for at least 4 weeks are eligible.
– Has unresolved toxicity from previous anticancer therapy. May be eligible after discussion between treating physician and sponsor.
– Has multiple primary malignancies within 3 years.
– Has substance abuse issues or other medical conditions that, in physician opinion, would interfere with patient’s ability to participate in the study.
Additional exclusion criteria may apply and will be discussed with study team and physician.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HARMONi-3 Study: A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the first-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Study sponsor: Summit Therapeutics Sub, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This is a randomized study – meaning you have a random chance to be assigned to either the study drug arm, which is Ivonescimab (study drug) + chemotherapy, OR to the standard arm, which is Pembrolizumab (Keytruda) + chemotherapy. The main purpose of the study is to look at overall survival of patients that are taking the study drug plus chemo, vs. the patients taking pembrolizumab plus chemo. The study drug works by attacking or interfering with 2 different parts of cancer growth at the same time. It interferes with the development of new blood vessels to the tumor, and also stimulates the body’s immune system to better identify cancer cells and destroy them.
Inclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Exclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HARMONi-7: Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (TPS ≥ 50%)
Study Sponsor: Summit Therapeutics
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of the study is to compare how effective the study drug Ivonescimab is vs. Pembrolizumab (Keytruda) at treating metastatic non small-cell lung cancer. This is a randomized study, meaning you will randomly be assigned to either the study drug arm or the Pembrolizumab arm. It is also blinded, which means you and your doctor will not know whether you are receiving the study drug or the standard of care drug. Only the pharmacist which prepares the drug will know which drug you are receiving.
Inclusion Criteria:
– Must be 18 years or older.
– ECOG of 0 – 1.
– Expected life expectancy of at least 3 months or greater.
– has metastatic (Stage IV) non small-cell lung cancer (Squamous OR non-squamous).
– Has high PD-L1 expression of at least 50% or greater.
– Has at least 1 measurable lesion per RECIST 1.1.
– No prior treatment for metastatic non small-cell lung cancer. Patients receiving adjuvant, neoadjuvant chemotherapy, or curative-intent chemoradiation may be eligible if their last therapy was at least 6 months prior to developing metastatic disease.
– Has adequate organ function as determined by local lab tests.
– Female patients of childbearing potential must test negative on serum pregnancy test, and must agree to highly effective methods of contraception. Male patients must also agree to highly effective methods of contraception while on study drug and up to 120 days after the last dose.
*Additional inclusion criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Has small-cell lung cancer.
– Has known genetic mutations for which there exist targeted therapies.
– Has received prior therapy for non small-cell lung cancer in the metastatic setting.
– Is enrolled in another clinical trial (unless the clinical trial is not interventional – meaning you are not receiving a study drug).
– Evidence per CT that the tumor is invading blood vessels or organs. Additionally, patient is ineligible if the physician determines there is a significant risk of bleeding.
– Symptomatic central nervous system metastasis with hemorrhagic features, metastasis of > or = to 1.5cm, radiation within 7 days prior to randomization, or a need for radiation within the first cycle.
– Other prior malignancies unless patient has received curative therapy with no disease recurrence for 3 years prior to being randomized.
– Active autoimmune or lung disease requiring prednisone of >/=10mg per day or equivalent. (Exceptions include corticosteroid replacement therapy, insulin, thyroxine.)
– History of major disease prior to randomization such as significant cardiac events (congestive heart failure, myocardial infarct, etc.), Grade 3 thrombus event, exacerbation of COPD, history of GI-tract perforation or GI obstruction.
– Patients with >30Gy of radiation to chest within 6 months prior to randomization.
– Pre-existing peripheral neuropathy of Grade 2 or higher.
– Live vaccine within 4 weeks.
– Sever infection, or major surgery within 4 weeks prior to being randomized.
– History of bleeding or coagulation issues within 4 weeks prior to randomization.
– Poorly controlled hypertension, uncontrolled pleural or pericardial effusions, or symptomatic ascites.
– Active or prior history of inflammatory bowel disease, known HIV, or history of pneumonia requiring systemic steroids.
*Additional exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
HC366-RC2311: A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC-7366 in Combination with Belzutifan (WELIREGTM) in Patients with Locally Advanced (Inoperable) or Metastatic Renal Cell Carcinoma
Study Sponsor: HiberCell Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This study is looking to test the safety and effectiveness, and to find the highest tolerated dose of study drug HC-7366 as single drug or in combination with Belzutifan (Welireg) in patients with Renal Cell Carcinoma. The study has two parts – a dose escalation phase (Finding the highest tolerated dose), and a dose expansion phase (further testing at the highest dose). The study drug works by interfering with cancer cells’ ability to feed themselves and potentially prevent their growth.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must have confirmed diagnosis of metastatic Renal Cell Carcinoma.
– Must have progressive disease after receiving at least 2, and no more than 5 prior therapies for stage 4 disease.
– Must have at least 1 measurable lesion per RECIST 1.1.
– Has no RCC tumor that requires immediate surgery.
– If reasonably accessible with minimal risk and patient willing, at least one biopsy at baseline and another at cycle 2 day 1.
– Must have ECOG of 0-1.
– Has adequate organ function as determined by lab tests.
– Must not experience more than 10% weight loss in the last 4 weeks prior to starting study drug.
– Must have at least a 3-month life expectancy as determined by treating physician.
– If female patient of childbearing potential, must agree to highly contraceptive method or maintain abstinence from intercourse during the trial period and at least 90 days following the last dose of study drug. Also must have negative serum pregnancy test at screening.
– Male patients must abstain from intercourse or agree to using highly contraceptive methods during trial period and at least 90 days after the last dose of study drug.
– Additional inclusion criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Patient is excluded if they have had prior treatment with Belzutifan or other HIF-2α inhibitor.
– Has received any type of small molecule kinase inhibitor within 2 weeks prior to study.
– Is currently receiving an investigational drug or device within 4 weeks prior to starting study.
– Has received radiotherapy within 2 weeks prior to study. Patient must have recovered from radiotherapy related toxicities and not require corticosteroids. A 1-week washout is required for palliative radiation to non-Central Nervous System disease.
– Is immunodeficient or receiving systemic steroid therapy or other immunosuppressive therapy within 14 days prior to first dose of study drug.
– Has any of the following: Pulse oximeter reading of <92%, requires intermittent supplemental or chronic supplemental oxygen.
– Has history of lung disease or pneumonitis within 12 months prior to screening.
– Has clinically significant cardiovascular disease within 6 months from first study drug administration (specifics to be discussed with physician/study team).
– Has additional known malignancy that is progressing or has required active treatment within the last 5 years. Basal cell or squamous cell carcinoma are excluded. Other malignancies are also eligible if they were cured by surgery alone, surgery plus radiotherapy and have been disease free for at least 5 years.
– Has history of, or active central nervous system metastasis. May be able to participate if CNS is radiologically stable for at least 4 weeks and no evidence of enlargement.
– Has moderate to severe Child-Pugh B or C.
– Has known hypersensitivity to active ingredients of study drug or Belzutifan.
– Has history or retinitis or photosensitive skin disorders.
– Has history of severe autoimmune disease or history of organ transplant.
– Is unable to swallow oral medications or has evidence of GI disorder that may impact drug absorption.
– Has known active HIV or Hepatitis B or C.
– Is currently receiving strong or moderate Inducers or Inhibitors of Cytochrome P450 (CYP3A4) that cannot be discontinued during the study.
– Has a history of, or any other active condition that, in the opinion of the investigator, would interfere with the individual’s ability to cooperate with the study requirements.
– Other exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@parknicollet.com
HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects with Locally Advanced or Metastatic Solid Tumors
Study sponsor: Daiichi Sankyo
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: II
Purpose of study: The purpose of the study is to determine safety and effectiveness of the study drug Partitumab Deruxtecan (also known as HER3-DXd or U3-1402). The study drug is known as an Antibody Drug Conjugate (or ADC). An antibody is a protein that is produced by the immune system to identify and get rid of foreign objects like bacteria. ADCs are composed of an antibody attached to an anticancer drug. ADCs are made to attach to tumor cells. Once attached to the cell, the ADC is taken inside the tumor cell and the anticancer drug is released inside to kill the cancer cell.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must have locally advanced unresectable or metastatic disease.
– At least 1 measurable lesion per RECIST 1.1 via CT or MRI. Prostate cancer subjects with bone only lesion may be eligible.
– Able to provide pre-treatment tissue as the following: a. Tissue collected from biopsy that was performed since progressing while on, or after treatment with the most recent systemic cancer therapy prior to signing consent, OR b. patient is amenable to a pre-treatment biopsy after signing informed consent for the study. (Pretreatment tissue requirement may potentially be waived if discussed with, and approved by the medical monitor)
– ECOG of 0 – 1.
– Has adequate organ function as determined by local lab tests.
– Female patients of childbearing potential, and male patients with partners of childbearing potential must agree to use highly effective forms of birth control during the treatment period and for at least 4 months after the last dose of study drug. Additionally, female patients may not donate or retrieve ova from time of screening through at least 7 months after last dose of study drug, and male patients may not donate or freeze sperm from time of screening through 4 months after the last dose.
– Must be willing to comply with scheduled visits, drug administration plan, lab tests, and other study procedures, and must adhere to study restrictions.
Cohort specific criteria below:
– Cutaneous (acral and non-acral) melanoma:
a. Histologically or cytologically confirmed cutaneous melanoma.
b. disease progression while having received treatment with at least 1 prior line of anti-PD-1 or anti-PDL1 therapy. If patient has BRAFm melanoma, must have progressed on a BRAF/MEK inhibitor therapy as well.
– Squamous cell carcinoma of the head and neck:
c. SCC of head and neck with HPV positive or negative (as determined by local standard). Excludes primary tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.
d. Disease progression after having received at least 1 and less than 3 prior lines of systemic therapy in the metastatic setting. Must have disease progression after treatment with anti-PD1/ anti-PD-L1 therapy (either as monotherapy or in combination with chemotherapy or other therapies). Must also have disease progression on PBC regimen in recurrent or metastatic setting, or in locally advanced setting with curative intent.
– Gastric or GEJ adenocarcinoma:
e. Tumor tissue confirmed as negative for HER2 expression as per ASCO-CAP guidelines. Determined prior to enrollment by local lab assessment or other accredited
f. Disease progression after treatment with at least 2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.
– Ovarian carcinoma:
g. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
h. Documented progression at least 4 weeks after last dose of PBC and less than 6 months after last dose of PBC in the advanced / metastatic setting. Prior folate reductase alpha-targeting ADC (such as mirvetuximab soravtansine) is allowed.
– Endometrial cancer:
k. Pathologically or cytologically documented endometrial cancer, irrespective of MSI or mismatch repair status.
l. documented disease progression after at least 1 line of therapy (and maximum of 3) PBC containing systemic treatment and an anti-PD-1/ PD-L1 therapy in the advanced / metastatic setting.
– Bladder cancer:
m. Pathologically or cytologically confirmed urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is the predominant. small cell / neuroendocrine tumors are not allowed, even if mixed histology.
n. Relapsed or progressed after treatment with at least 1 (and maximum of 3) that contains anti-PD-1/anti-PD-L1 therapy in perioperative or metastatic setting. At least 1 line of therapy must contain following treatment modalities: Chemo or enfortumab vedotin. Prior FGFR-inhibitor treatment for those who are eligible are allowed. (Required treatments can be given in combination or sequentially. Prior cisplatin-based therapy or PD-1/PD-L1 given for treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy. Same regimen administered twice in different disease settings is counted as 1 line of prior therapy)
– Esophageal Carcinoma:
o. Pathologically or cytologically documented esophageal squamous cell carcinoma.
p. must have documented disease progression after receiving 2 prior lines of therapy including previous PBC with or without anti-PD-1 therapy in advanced or metastatic setting.
– Pancreatic carcinoma:
q. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.
r. Relapsed or disease progression after 1 prior line of systemic therapy in locally advanced / metastatic setting.
– Prostate Cancer:
s. Pathologically or cytologically documented unresectable locally advanced or metastatic CRPC.
t. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
u. Surgically or medically castrated, with testosterone levels of <50ng/dL.
v. Documented radiographic progression for patients with measurable disease after androgen deprivation.
w. Relapsed or disease progression after at least 1 of the following: abiraterone, enzalutamide, apalutamide, or darolutamide.
x. Relapsed or disease progression after receiving at least 1 cytotoxic chemotherapy that included a taxane.
*Additional criteria may apply and will be discussed with the treating physician and research team.
Exclusion Criteria:
– Has HER2-positive gastric cancer classified by ASCO-CAP guidelines prior to enrollment.
– Has Nasopharyngeal cancer.
– Has mucosal or uveal melanoma.
– Has history of ILD/pneumonitis which required corticosteroids, or has current ILD/pneumonitis.
– Has clinically significant respiratory compromise from pulmonary illnesses including but not limited to:
a. Any underlying pulmonary disorder (i.e. pulmonary emboli within 3 months prior to cycle 1 day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, or pleural effusion).
b. any autoimmune or connective tissue, or inflammatory disorders (i.e. rheumatoid arthritis, Sjorgen’s syndrome, and sarcoidosis), where there is documented or suspicion of pulmonary involvement at time of screening.
c. Prior complete pneumonectomy.
-Is receiving chronic systemic corticosteroids of at least 10mg prednisone or equivalent, or any form of immunosuppressive therapy prior to cycle 1 day 1. Patients on bronchodilators, inhaled/topical steroids, or local steroid injections may be included in the study.
– Has history of, or evidence of current leptomeningeal disease.
– Has clinically significant corneal disease.
– Has evidence of clinically active spinal cord compression, or brain metastasis – defined as symptomatic or untreated, or requiring corticosteroid or anticonvulsant therapy to control symptoms. Patients with clinically inactive or treated brain mets who are asymptomatic may be included if they are neurologically stable for at least 4 weeks prior to cycle 1 day 1.
– Had inadequate washout period prior to Cycle 1 Day 1 as follows:
a. whole brain radiation within 28 days, or stereotactic radiation within 7 days.
b. cytotoxic chemo, other investigation agent, or other anticancer therapy within 14 days (or 5 half-lives, whichever is longer).
c. any ICI therapy within 21 days.
d. any mAbs other than ICIs, such as VEGF or anti-EGFR within 28 days.
e. Major surgery within 28 days.
f. Radiotherapy treatment to more than 30% of bone marrow, or wide field radiation within 28 days, or palliative radiation within 7 days.
g. Chloroquine or hydroxychloroquine within 14 days.
– Had prior treatment with anti-HER3 antibody, or ADC that contains extacecan derivative that is a topoisomerase I inhibitor.
– Has unresolved toxicities from previous anticancer therapy that has not resolved to at least grade 1 or baseline per CTCAE guidelines. (Subjects with Grade 2 toxicities that have not worsened for greater than 3 months prior to Cycle 1 Day 1 may be enrolled if toxicity is deemed manageable by the treating physician. These can include things such as: Chemo-induced neuropathy, fatigue, residual toxicities from prior immuno-oncology treatment: grade 1 or grade 2 endocrinopathies including hypo/hyperthyroidism, Type 1 diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation).
– History of other active malignancy within 3 years prior to Cycle 1 Day 1 except: adequately treated melanoma skin cancer and adequately treated thin primary melanoma <1m. Adequately treated intraepithelial carcinoma of the cervix. Any other curatively treated in situ disease. Early prostate cancer (T1-T2a, Gleason score </=6 and PSA <10ng/mL) not requiring treatment.
– Has uncontrolled or significant cardiovascular disorder prior to cycle 1 day 1.
– Has active HCV infection or uncontrolled HIV 1/2 infection. HIV infected patients must meet certain criteria to be deemed eligible.
– Has active HBV infection.
– Has evidence of severe or uncontrolled disease, psychiatric illness, social situation, geographical factors, substance abuse, or other factors that, in the treating physicians opinion would make the patient high-risk to participate in the study.
– Has known hypersensitivity to either drug substance or inactive ingredients in drug product.
– Female subject who is pregnant or breastfeeding or intends to become pregnant during the study.
– Has ongoing clinically relevant illness, medical condition, surgical history, lab finding or abnormality that, in the treating physician’s opinion, would pose risk to safety of the patient.
– Has previously received irinotecan treatment in advanced or metastatic disease setting.
*Additional criteria may apply and will be discussed with the treating physician and research team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HLX10-005-SCLC301-E: A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Study Sponsor: Shanghai Henlius Biotech
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: III
Purpose of study: This is a Phase 3 study that is looking to study the effects of the study drug HLX10 combined with chemotherapy on extensive-stage small-cell lung cancer. Patients are randomly assigned to either the experimental arm – the study drug + chemotherapy, or the control arm – Atezolizumab (Tecentriq) + chemotherapy. The study drug works by targeting PD-1, and helps restore the body’s function to recognize and combat cancer cells.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must be diagnosed with extensive-stage small-cell lung cancer.
– Must not have had any previous therapy for ES-SCLC
– Patients that received chemoradiotherapy for limited stage SCLC must be treated with curative intent and must have treatment-free period of at least 6 months from the last course of chemo, radiotherapy, or chemoradiotherapy until diagnosis of extensive stage SCLC.
– Must have at least 1 measurable lesion per RECIST 1.1.
– ECOG of 0 – 1.
– Expected survival of at least 12 weeks.
– Normal organ function as determined by screening lab tests.
– Female patients may meet any of the following: Menopause (menses for at least 1 year), or surgically sterilized, or, if of childbearing potential, must have negative serum pregnancy test within 7 days prior to being randomized to the study, and must agree to using highly contraceptive methods while on study treatment. Additionally, must not be breastfeeding.
– Male patients must agree to abstinence or take contraceptive measures through 6 months post last dose of study treatment.
– Additional criteria may apply, and will be discussed with the physician and study team.
Exclusion Criteria:
– Confirmed mixed small-cell lung cancer.
– Other active malignancies within 5 years or at the same time.
– Patients who are preparing for, or have received an organ or bone marrow transplant.
– Pleural or pericardial effusion requiring intervention, or ascites.
– Patients with known Central Nervous System metastases and/or meningitis at screening. The following will be allowed: subjects with asymptomatic brain metastases – will be required to have regular brain imaging done. Subjects with treated brain mets that have been stable for at least 2 months and with discontinued steroids 3 days prior to study start.
– Patients with spinal cord compression that has not been treated with surgery or radiotherapy.
– Patients with myocardial infarct within half a year prior to first dose, or with poorly controlled arrhythmias.
– Class 3 or 4 cardiac insufficiency or LVEF <50%.
– Uncontrolled or symptomatic hypercalcemia.
– Grade 2+ peripheral neuropathy
– HIV infection or positive test for HIV antibody.
– Active pulmonary tuberculosis.
– Previous and current pneumonia, pneumoconiosis, radiation pneumonitis or impaired pulmonary function that, in the opinion of the physician, may interfere with detection and management of study drug-related pulmonary side effects.
– Hepatitis B or C infection.
– Known active or suspected autoimmune diseases. Patients that are stable and that do not need immunosuppressant therapy are allowed to enroll.
– Treatment with live vaccines, COVID-19 vaccine, within 28-days prior to study drug administration. Inactivated viral vaccines for seasonal flu are allowed.
– Patients that are requiring treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to first dose. (Subjects are allowed to use topical or inhaled steroids, and adrenal hormone replacement therapy at less than or equal to 10mg/day of prednisone or similar).
– Active infection requiring systemic therapy within 14 days prior to study drug administration. Patients with history of Covid-19 infection must have negative PCR test prior to first dose of study drug.
– Major surgery within 28 days or radiation within 3 months prior to study start.
– Patient has previously received other immune-checkpoint inhibitors such as PD-1, PD-L1, CTLA4.
– Is currently participating in another ongoing clinical trial or is less than 14 days from the end of a previous clinical trial treatment.
– Has known history of allergy to any monoclonal antibody, or known hypersensitivity to carboplatin or etoposide.
– Additional criteria may apply, and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
INBRX-106: An Open-Label, Multicenter, First-in Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination with Pembrolizumab in Subjects with Locally Advanced or Metastatic Solid Tumors
Study sponsor: Inhibrx, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: 1/2
Purpose of study: The purpose of the study is to determine the safety and tolerability of the study drug INBRX-106. INBRX-106 works by activating OX40, which is a stimulant for the immune system. If INBRX-106 works, it should stimulate your immune system, which in turn can help your body fight the tumor. This mechanism is similar to CTLA-4, PD-1 or PD-L1 blocking antibodies (called immune checkpoint inhibitors), which have been approved by the FDA for the treatment of certain tumors.
Inclusion Criteria:
– Must be age 18 or older at time of signing informed consent.
– Tumor types included:
Part 4 (study drug in combination with Pembrolizumab) – Cohort F3: non-small cell lung cancer that has had no more than 2 lines of standard therapy including at least 1 anti-PD1/L1 drug. Cohort F4: Checkpoint inhibitor naïve with confirmed Head and neck squamous cell carcinoma, or confirmed nasopharyngeal carcinoma. Must have been treated with 0-1 prior lines and HNSCC patients, minimum of 4 must provide fresh biopsies. Cohort F7 – NSCLC.
– Must have PD-L1 tests available or provide tissue for PD-L1 testing at screening to be eligible. At least 50% TPS score for Cohorts C3 and F3. At least 1% for cohort F4, and 0% + is acceptable for Cohort F7.
– Must have measurable disease by RECIST 1.1
– Adequate organ function as determined by local lab tests.
– ECOG of 0-1.
– Patients must agree to highly effective methods of contraception or abstinence during and 4 months after the last dose of study drug.
Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Prior exposure to OX40 agonists.
– For part 4 cohort F4 only: prior exposure to anti-PD-1/PD-L1 checkpoint inhibitors in the relapsed or metastatic setting.
– received any investigational or approved anticancer drug within 4 weeks prior to first dose of study drug. (Hormone replacement therapy is allowed).
– Radiotherapy within 2 weeks prior to first dose. 1-week washout is permitted for palliative radiation to non-CNS disease.
– Allergy to INBRX-106 or known allergies to antibodies produced from Chinese Hamster ovary cells which could suggest increased potential for hypersensitivity to study drug.
– Hypersensitivity to pembrolizumab or any of its excipients, to chemo agents, or to folic acid or vitamin B12.
– Hematologic malignancies
– For patients with NSCLC:
- cohorts F3 and F7: Received radiation therapy to lung >30Gy within 6 months prior to first dose
- F3 + F7: patients with non-squamous NSCLC with EGFR mutations or ALK gene rearrangements
- Cohort F7: unable to take folic acid or vitamin B12 supplements. Squamous histology is excluded. Mixed is allowed is the predominant type is non-squamous. Also excluded if small cell elements are present.
– Has known active CNS metastases or carcinomatous meningitis. Patients with previously treated brain mets are able to participate provided they are radiologically stable and without evidence of progression for 4 weeks, and also do not require corticosteroids for at least 14 days prior to first dose of study drug.
– Prior or concurrent malignancies. Some exclusions are allowed after discussion between physician and study medical monitor.
– Grade 3 or higher immune-related adverse event that resulted in discontinuation of prior therapy.
– Active or documented autoimmune disease that requires systemic steroids or immunosuppressive medications. (hormone replacement therapy is an exception and is allowed).
– immunodeficiency or treatment with systemic immunosuppressive medication within 7 days prior to first dose of study drug.
– Patients that received granulocyte colony-stimulating factor or erythropoietin within 14 days prior to first dose.
– history of Hepatitis B or C, or HIV.
– HIV patients must be on anti-retroviral therapy, and have controlled HIV disease at time of screening.
– Subjects with past or ongoing HCV infection are eligible if completed treatment 1 month prior to starting study drug and have negative HCV RNA test at screening.
– Clinically significant cardiac condition.
– Active interstitial lung disease, pneumonitis, or history of, requiring treatment with immunosuppressive meds or steroids.
– Pulmonary embolism within 12 weeks prior to first dose.
– Major surgery within 4 weeks prior to first dose.
– Active infection requiring systemic therapy within 4 weeks prior to first dose.
– Pregnant or nursing.
– Prior allogenic organ transplant or stem cell/bone marrow transplant.
– Live vaccine within 4 weeks prior to first dose of study drug.
– Any known documented or suspected history of substance abuse that in the opinion of the physician would interfere with the patient’s ability to adhere to study required visits and requirements.
Additional criteria may apply and will be discussed with the physician and study team.
Additional criteria may apply and will be discussed with the physician and study team.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
MK-5684-004: A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Next generation Hormonal Agent (NHA)
Study sponsor: Merck Sharpe & Dohme LLC
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to test the safety and effectiveness of the study drug MK-5684 combined with hormone replacement therapy (HRT) compared to alternative Abiraterone acetate or Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC).
Inclusion Criteria:
– Have histologically or cytologically confirmed adenocarcinoma of prostate without small cell histology.
– Have current evidence of metastatic disease documented either by bone lesions on bone scan, or by soft tissue disease documented by CT or MRI scan.
– Has prostate cancer progression while receiving androgen deprivation therapy.
– Has had disease progress during or after treatment with one next-generation hormonal agent.
– Has ECOG of 0 – 1.
– Has adequate organ function as determined by lab tests.
– Has provided tumor tissue from fresh core or excisional biopsy from soft tissue that was not previously radiated.
– Participants that test positive for Hepatitis B are eligible if they have received antiviral therapy for at least 4 weeks, and have undetectable load prior to randomization. Additionally, participants with Hepatitis C are eligible if viral load is undetectable at screening.
– HIV positive patients must be on well controlled antiretroviral therapy.
– Additional criteria may apply and will be discussed with the study team and physician.
Exclusion Criteria:
– Has other Gastrointestinal condition
– Unable to swallow capsules/tablets
– Has poorly controlled diabetes mellitus
– Has active or unstable cardio/Cerebro-vascular disease or thromboembolic events.
– Has significant abnormal sodium or potassium levels, or hypotension at screening.
– History or family history of long QTc Syndrome.
– Has history of seizures within 6 months prior to signing consent, or condition that may predispose to seizures within 12 months prior to signing consent.
– Has previously received Taxane-based chemotherapy or next-generation hormonal agent for metastatic castration-resistant prostate cancer.
– Has not recovered from previous major surgery or has ongoing surgical complications.
– Has received prior treatment with Radium for prostate cancer.
– Has received CYP450-inducing antiepileptic drugs for seizure.
– Has received radiotherapy within 2 weeks prior to first dose of study drug.
– Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study drug.
– Has received prior systemic therapy including other investigational drugs, or investigational devices within 4 weeks prior to first dose of study drug.
– Has received a live or live-attenuated vaccine within 30 days prior to first dose of study drug.
– Has known hypersensitivity to components or excipients in abiraterone acetate, prednisone or prednisolone, or enzalutamide.
– Has known other malignancy that is progressing or has required active treatment within the past 3 years.
– Is receiving chronic systemic steroid therapy (>10mg / day of prednisone or equivalent).
– Has known central nervous system metastases. Patients with previously treated brain Mets may participate if they have been radiologically stable for 4 weeks and have not required steroid treatment for at least 14 days prior to first dose of study drug.
– Has active autoimmune disease that required systemic treatment in the last 2 years.
– Has active infection that requires treatment.
– Has concurrent Hepatitis B and Hepatitis C virus infection.
– Additional criteria may apply and will be discussed with the study team and physician.
Study Contact:
Alissa Gavenda, RN
(952) 992-5705
Alissa.Gavenda@ParkNicollet.com
Preserve-003: Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors.
Study sponsor: OncoC4, Inc., BioNTech SE
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This research study is a Phase 3 clinical trial, which tests the effects of ONC-392 for the treatment of lung cancer compared to a standard of care chemotherapy drug, docetaxel. The most important measurement for the study is to see how long the treatment could prolong your life. ONC-392 is an investigational drug being developed as an anti-tumor treatment.
ONC-392 is an antibody drug that binds to immune cells inside the tumor mass. The target molecule (protein) is called CTLA-4. ONC-392 binds to CTLA-4 and acts to reduce the regulatory immune cells and to let normal immune cells get into the tumor mass to fight against the tumor. ONC-392 has been tested in early Phase 1 and Phase 2 ongoing studies since 2020. This study will enroll participants who have non-small cell lung cancer and have disease progression after platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 based immunotherapy. You will be randomized to receive either ONC-392 or the currently FDA approved standard of care chemotherapy agent docetaxel.
Inclusion Criteria:
– Must be at least 18 years old
– Must have histologically or cytologically confirmed diagnosis of metastatic non small-cell lung cancer (metastasis can be regional lymph nodes or distant organs).
– Progression of disease with most recent line of treatment for 3a or 3b: a) at least 12 weeks of standard dose of PD-1/PD-L1 inhibitor in combination with platinum chemo, b) Prior treatment with at least 2 cycles of platinum chemo followed by 12 weeks of standard PD-1/PD-L1 immunotherapy.
– Must have measurable disease via RECIST 1.1
– Must have ECOG of 0 – 1.
– Must have adequate organ function as determined by local lab tests.
– Must have at least a 3-month life expectancy.
– Sexually active Women of childbearing potential (WOCBP) must agree to highly effective contraceptive use starting at screening and continuing through 90 days after last dose of study drug.
– Sexually active male patients must agree to highly effective contraceptive methods from screening through 90-days after last dose.
– Must agree to allow study team to access archival tissue/ or treatment tissue from biopsy or surgery.
Exclusion Criteria:
– Any patient that has not recovered to baseline from previous anticancer therapy.
– Any patient currently enrolled in another clinical trial that is testing an investigational drug or device, or an approved systemic therapy that contains anti-PD-1/ anti-PD-L1 within the last 28 days prior to first day of study treatment.
– Patients with chronic steroid therapy of greater than 10mg per day or prednisone or equivalent within 7 days prior to first dose of study drug.
– Patients with documented mutations or genetic alterations in the following genes: EGFR, ROS1, MET, BRAF, RET, NTRK, ALK, or HER2.
– Patients with active of symptomatic brain metastasis or evidence of progression within 4 weeks prior to study drug.
– Patients with active GI disease such as Inflammatory Bowel Disease, diverticulitis, pancreatitis, or peptic ulcer disease, etc are excluded.
– Patients with current, active, or prior history of Interstitial lung disease, or pneumonitis, that required high dose steroids.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
alissa.gavenda@parknicollet.com
STK-012: A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors
Study sponsor: Synthekine, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The purpose of this study is to test the safety and tolerability of the study drug STK-012 as a single drug, or in combination with other therapy. The drug works by helping to trigger the body’s immune system to attack the cancer cells, and destroying the cells so that they can’t multiply and divide.
Inclusion Criteria:
– Must be at least 18 years or older.
– Life expectancy of at least 3 months as determined by the treating physician.
– Must have measurable disease via RECIST 1.1.
– ECOG of 0 – 1.
– Adequate organ function as determined by local lab tests within 28 prior to first dose.
– Female patients of childbearing potential must have a negative serum pregnancy test within 72hrs prior to first dose of study drug, and must also agree to highly effective birth control methods during treatment, and for at least 180 days post last dose unless meeting the following criteria: Over the age of 60, postmenopausal with no menses for 1 year, and confirmed by FSH, history of hysterectomy and/or bilateral oophorectomy, or a history of bilateral tubal ligation.
– Male patients must also agree to highly effective methods of contraception and refrain from donating sperm during treatment, and for 180 days after the last dose.
– Patients must have adequate archival tissue within 24 months of screening. If archival tissue is not available, a fresh biopsy is required (unless deemed unsafe by the treating physician and discussion with the study medical monitor).
– Must have confirmed Stage IV non-squamous non small cell lung cancer.
– Patient’s tumor must be predominantly non-squamous histology. If small cell elements are present, patient will be ineligible.
– Must not have any known actionable gene mutations for which there are approved targeted therapies.
– Subjects in part E can have any level of PD-L1 expression (TPS of 0-100%), subjects in part F must have negative PD-L1 (TPS<1%) per local testing.
– Must not have received prior treatment for advanced NSQ NSCLC (Subjects that received adjuvant, neoadjuvant, or consolidation therapy are eligible for the study if the therapy was completed at least 12 months prior to recurrence or progression).
*Additional inclusion criteria may apply and will be discussed with the physician and research team*
Exclusion Criteria:
– Received systemic anticancer therapy within 3 weeks prior to first dose.
– Received radiation therapy within 2 weeks prior to first dose.
– Received prior treatment with IL-2 or IL-15 based cytokine therapy.
– Has history of pulmonary fibrosis (including pneumonitis), drug or radiation induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT.
– Currently participating in, or has participated in a study of an investigational agent or investigational device within 4 weeks prior to first dose of study drug. Subjects that entered a follow-up phase of an investigational study may participate if at least 4 weeks has passed since the last dose of previous treatment.
– Has received prior therapy with anti-PD1 or anti-PD-L1 agent, or agent directed to other receptors (such as CTLA-4, OX40, or CD137).
– Failure to recover from immune-related adverse event from previous immunotherapy. (Patients with sensory neuropathy, alopecia, or endocrinopathies that are controlled by hormone-replacement therapy, or other grade 2 or less event that in the physician’s opinion does not pose a safety risk to the patient, are eligible).
– Failure to recover from other non-immune-related toxicities from prior therapy to at least grade 2 or less.
– Known active brain mets. Patients with treated brain mets may be eligible if they are clinically stale and without need of steroid treatment for at least 14 days prior to first dose of study drug.
– Hypersensitivity of Grade 3 or higher to monoclonal antibodies, including pembrolizumab or any of its excipients.
– Known history or, or active autoimmune disease or syndrome that requires steroids or immunosuppressive agents. (patients with Vitiligo, type 1 diabetes mellitus, resolved childhood asthma, hypo- or hyperthyroidism due to autoimmune condition that doesn’t require immunosuppressive treatment, psoriasis, atopic dermatitis, or other skin condition that is managed without systemic therapy, or arthritis that is managed without systemic therapy beyond oral acetaminophen and NSAIDs are allowed).
– History of allogenic/solid tissue organ transplant.
– Clinically significant cardiovascular disease or risk factors at screening that include the following: cerebral vascular accident/stroke, or myocardial infarction, unstable angina, congestive heart failure (>/=NYHA class 2), or serious cardiac arrhythmia requiring medication. QTcF>470 on screening ECG, or congenital long QT syndrome. TdP, including hypokalemia or hypomagnesemia, history of significant or symptomatic bradycardia. Family history of sudden death or congenital long QT syndrome. Concomitant medications with known risk of Torsades De Pointe that cannot be discontinued or replaced with safe alternative within 6 half-lives before first dose of study drug.
– History of other clinically unstable/uncontrolled disorder, condition, or disease, that in the opinion of the physician, would pose a risk to patient safety, or interfere with the study evaluations, procedures, or completion.
– Serious active bacterial, viral, parasitic, or systemic fungal infections requiring systemic treatment within 30 days prior to first dose of study drug.
– Known additional malignancy that is progressing, or has required active treatment within the last 2 years (Patients with basal cell, squamous cell skin cancer, or carcinoma in situ that has undergone curative therapy are not excluded from being able to participate in the study).
– Has received a live-virus vaccine within the last 30 days prior to first dose of study drug (Seasonal flu and covid-19 vaccines that do not include live virus are permitted).
– Known history of testing positive for HIV or AIDS, or testing positive for HIV by positive serum HIV test at screening.
– Active hepatitis B or C infection at screening as confirmed by local lab tests.
– Pregnant, breastfeeding, expecting to conceive, or to father children within the duration of the study, starting at screening and through 180 days after the last dose of study drug.
*Additional criteria may apply and will be discussed with the physician and research team*
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
SUNRAY-01: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C
Study sponsor: Eli Lilly and Co.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. The study drug works by attaching itself and keeping the mutated gene in an inactive form so that it stops the tumor cells that have this mutation from continuing to grow. The study has 2 parts; Part A – patients are randomly selected to either Study drug in combination with Pembrolizumab (Keytruda), or to Placebo in combination with Pembrolizumab. Part B – patients are randomly selected to either study drug + pembrolizumab + chemotherapy, OR to placebo + pembrolizumab + chemotherapy. Regardless of which combination, patients still receive at least standard therapy.
Inclusion Criteria
– Must be at least 18 years or older.
– Must have confirmed non-small cell lung cancer with stage IIIB-IIIC or stage IV disease.
– Must have confirmed KRAS G12C mutation.
– Must have a known PD-L1 expression as determined by lab tests.
– Must have measurable disease based on RECIST 1.1
– ECOG of 0 – 1
– Have life expectancy of at least 12 weeks
– Must be able to swallow capsules.
– Women of childbearing potential must have negative serum pregnancy test within 24hrs prior to first dose and must not breastfeed during treatment and for at least 180 days after the last dose is given.
Additional criteria may apply and will be discussed with physician and research team.
Exclusion Criteria
– Patient has additional targetable mutation or alteration in genes such as EGFR, ALK, BRAF, HER2, MET, ROS1, RET, or NTRK1/2/3.
– Has known brain metastasis or carcinomatous meningitis. Participants with brain mets may participate in study if any treatment for CNS was completed at least 14 days prior to study start. Patient must also be radiologically, neurologically, and clinically stable for at least 14 days prior to being randomized. Patient also allowed to participate if brain mets are asymptomatic.
– Patient has significant cardiovascular disease or history of myocardial infarct or unstable angina for 6 months prior to study start.
– Has prolonged QT interval as determined by ECG.
– Has uncontrolled, disease-related, pericardial or pleural effusion.
– History of pneumonitis or interstitial lung disease that required treatment with steroids, or has current pneumonitis/interstitial lung disease.
– Has autoimmune disease that has required treatment in the last 2 years. (Replacement therapy such as thyroxine, insulin or physiologic corticosteroids for adrenal or pituitary insufficiency are allowed.)
– History or solid organ transplant or allogenic stem cell transplant.
– Has active fungal or bacterial infection, HIV, or viral hepatitis (A, B, or C). HIV patients must be on ART and have well-controlled disease as defined by specific criteria at screening.
– Patient has pre-existing medical condition that, in the opinion of the treating physician, would interfere with the patient’s ability to be on the trial.
– Have significant active malabsorption syndrome or other condition that would affect the patient’s ability to absorb the study drug.
– Other known malignancy that is progressing and has required active treatment within the past 2 years.
Additional criteria may apply and will be discussed with the physician and research team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
TTX-080-001: TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination with Pembrolizumab, Cetuximab, or FOLFIRI plus Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies (Arms 9 and 10 only)
Study Sponsor: Tizona Therapeutics, Inc.
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase I
Purpose of study: The purpose of the study is to assess the safety and determine the good and bad effects of an investigational drug called TTX-080 (the study drug). The purpose of this study is to understand how subjects with colorectal cancer might benefit from TTX-080 in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil (5- FU), and irinotecan hydrochloride) and cetuximab (approved treatments for colorectal cancer). TTX-080 is an antibody made in a laboratory and binds to a protein called HLA-G and blocks its suppressive function. Antibodies are naturally made by the body in reaction against foreign substances (such as bacteria and viruses) that get in the body. Some cells use HLA-G to suppress the body’s immune system response and help cancer cells grow. By blocking HLA-G, TTX-080 may help the immune system attack cancer cells. Cetuximab and FOLFIRI are approved by the FDA in the USA, and they are available by prescription to treat colorectal cancer. Cetuximab, a monoclonal antibody belonging to class of targeted agents, works by blocking a key protein called epidermal growth factor receptor (EGFR) found on the cancer cell surface. It may also help the immune system to fight cancer. FOLFIRI is a combination of chemotherapy treatments that works by destroying cancer cells.
Inclusion Criteria:
– Male or female patients ≥ 18 years of age at the time of screening.
– Histological or cytological diagnosis of mCRC that is considered incurable.
– Tumors must be MSS, WT for RAS, WT for BRAF, and HER2-negative. Results from local testing will be accepted for enrollment but tumor samples must be submitted for central confirmation within 30 days after study enrollment
– Patient must have previously received 5-fluorouracil and oxaliplatin-based chemotherapy with or without bevacizumab in the frontline setting for mCRC. Patients who received FOLFOX in the adjuvant setting will be eligible if the tumor relapses within 6 months of stopping treatment.
– Patients must NOT have received prior irinotecan, or anti-EGFR therapy such as cetuximab, or panitumumab but be eligible to receive cetuximab per approved label regarding tumor RAS status
– Patients must be able to provide adequate amount of tumor tissue for central laboratory testing of MSS, RAS, BRAF, and HER2 status
– At least 1 measurable lesion per RECIST 1.1
– ECOG of 0 – 1.
– Life expectancy of at least 12 weeks.
– Adequate organ function as determined by local lab tests.
– Must use highly effective methods of contraception through 120 days after last dose of study treatment.
Additional criteria may apply and will be discussed with the treating physician and study team.
Exclusion Criteria:
-Active brain or leptomeningeal metastases. patients may be able to participate if radiologically and clinically stable for at least 4 weeks.
-Patients who are at risk of life-threatening complications in the short term (uncontrolled effusions, pulmonary lymphangitis).
-Patients with other active malignancy within 3 years prior to enrolling in study. (some exceptions may apply such as non-melanoma skin cancer, superficial bladder cancer, carcinoma in situ of breast or cervix, localized prostate cancer in remission, or other non-invasive or indolent malignancy).
-Major surgery within 4 weeks prior to receiving first dose of study drug.
-Excluded if patient has received systemic anticancer therapy within 4 weeks prior to first dose.
-Active Hepatitis B or C infection.
-Uncontrolled pleural, pericardial effusion, or ascites that requires draining more than once every 28 days.
– Active known or suspected autoimmune disease, or if receiving immunosuppression for organ transplant.
– significant cardiac arrhythmias within the last 6 months, NYHA class III or IV congestive heart failure, or ongoing cardiac arrhythmias of Grade 2 or higher, or any grade of atrial fibrillation.
– Hypertension that requires more than 2 medications to control.
– participation in other studies involving investigational drugs within the last 28 days prior to first dose.
– History of allergy or hypersensitivity to study medication or its components.
– Women who are pregnant or breastfeeding.
Additional criteria may apply and will be discussed with the treating physician and study team.
Study Contact:
Lisa Wahowske , RN OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
The Connect for Cancer Prevention Study
Study sponsor: The National Cancer Institute (NCI), part of the National Institutes of Health (NIH)
Location: HealthPartners Neuroscience Center, Park Nicollet Clinic Chanhassen, Park Nicollet 3850 Building, HealthPartners Riverway Clinic Elk River, Park Nicollet Clinic Minneapolis, HealthPartners Clinic Brooklyn Center, HealthPartners Clinic Stillwater, New Richmond Clinic, Westfields Hospital & Clinic
Purpose of study: The Connect for Cancer Prevention Study will help us better understand the causes of cancer and how to prevent it. HealthPartners is one of ten health care systems throughout the country to partner with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for Connect. The study will include 200,000 adults.
Participants will be asked to answer online health surveys, donate samples of blood, urine, and saliva, and share access to their electronic health records. This information will help researchers study the health and behavior patterns that may affect cancer risk. It takes time to understand the causes of cancer, so Connect will go on for many years. The longer you participate, the more we may learn.
Inclusion Criteria: HealthPartners patients between 30 and 70 years old who have never had cancer. People who have or once had non-melanoma skin cancer, or a condition that raises the risk of getting cancer (such as DCIS, or stage 0 breast cancer), can still join.
Study Contact:
The Connect team at HealthPartners
(952) 967-5067
ConnectStudy@HealthPartners.com
XTX301-01/02-001: A First-in-Human, Multicenter, Phase 1, Open-Label Study of XTX301 in Patients With Advanced Solid Tumors
Study sponsor: Xilio Development Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The main purpose of this study is to determine if XTX301 is safe and well-tolerated in participants with advanced solid tumors. This is the first time XTX301 is going to be given to humans, so this study will also serve to determine the recommended XTX301 dose and schedule in later clinical studies.
Inclusion Criteria:
– Patient must be at least 18 years or older at time of consent.
– Must meet the following disease criteria:
a. Part 1A – any confirmed solid tumor that is locally advanced or metastatic that has failed standard treatments, or for which there is no standard therapy available.
b. Part 1B – Locally advanced or metastatic tumor that is any of the following: Melanoma, non-small cell lung cancer (NSCLC), Head and Neck Squamous cell, Triple-negative breast (TNBC), Cervical cancer, MSI-H/dMMR colorectal, or MSI-H/dMMR endometrial cancer.
– Patient must not have received prior anticancer therapy for at least 28 days prior to starting study treatment, and must have returned to baseline or grade 1 for any side effects from previous therapy.
– Must have ECOG of 0-2.
– Patient must have adequate organ function as determined by local lab tests.
– For Part 1B only: patients must be willing to undergo a tumor biopsy before starting, and while on study treatment.
– Women of Childbearing Potential (WOCBP) must be willing to abstain from sexual activity, or use highly effective contraception. Additionally, must also have a negative serum pregnancy test at the time of study enrollment and before each dose of study drug.
– Additional criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Must not have had previous treatment with IL-12 therapy
– Patients with known liver metastasis are excluded, unless previous discussion between treating physician and study medical monitor approves the patient to enroll.
– Concurrent anticancer therapy, immune therapy, or cytokine therapy, or other antineoplastic therapy during the study.
– History of significant pulmonary disease, interstitial lung disease or pulmonary fibrosis.
– History of significant heart disease, uncontrolled hypertension, congestive heart failure, or myocarditis.
– Possible area of non-disease related necrosis, such as an active ulcer, a non-healing wound, or intercurrent bone disease.
– Has active central nervus metastases, or carcinomatous meningitis.
– Active autoimmune disease that required therapy in the past 2 years, including use of corticosteroids, or immunosuppressive drugs.
– Has an active infection that requires systemic therapy within 4 weeks prior to receiving study drug.
– Has a history of Grade 3 or higher immune-related toxicities from prior immunotherapy unless it resolved within 14 days.
– Has had history of severe hypersensitivity to monoclonal antibodies
– Is pregnant or breastfeeding.
– Has active hepatitis B or C infection.
– Has had prior gene therapy treatment, organ transplant, or hematopoietic stem-cell transplant.
– Is currently using or has received another investigational drug or device within 4 weeks prior to starting study drug.
– Has received a live or live-attenuated vaccine within 4 weeks prior to first dose.
– Additional exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
Alissa.Gavenda@ParkNicollet.com
