AMG 193-20230167: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP deletion
Study Sponsor: Amgen Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase I
Purpose of study: The purpose of the study is to determine the maximum tolerated dose of study drug AMG193 given as a single drug, or in combination with other anti-cancer drugs in patients with metastatic or locally advanced MTAP-deleted lung cancer. The study drug AMG193 works by preferentially targeting tumor cells that lack the MTAP gene.
Inclusion Criteria:
– Must be at least 18 years or older at time of consent.
– Confirmed metastatic non small cell lung cancer without prior therapy for metastatic disease.
– MTAP-deletion per local NGS testing, OR MTAP protein loss per local IHC testing (discussed in greater detail with physician).
– Must have archival tumor tissue to submit to the study (tumor sample must be collected within the last 5 years).
– Must be able to swallow oral study drug.
– ECOG status of 0-1.
– Must have adequate organ function as determined by local lab tests
– Minimum life expectancy of at least 12 weeks in the opinion of the treating physician.
Additional inclusion criteria may apply, and will be discussed with the research team and physician.
Exclusion Criteria:
– Has had prior treatment for metastatic non small cell lung cancer. (Exception for patients that started standard platinum chemo or immunotherapy that receive their first dose within 28 days of signing the informed consent. Discuss with research team and physician for more detailed information)
– Has had a major surgery within 28 days prior to the first dose of the study drug (a fresh biopsy to fulfil the inclusion criteria is allowed)
– Side effects from prior treatments that have not resolved (some exceptions apply – such as hair loss or side effects that are well controlled)
– Has received radiation therapy within 28 days of the first dose of study drug.
– Has received a live vaccine within 4 week prior to first dose.
– Has untreated symptomatic brain metastasis, or asymptomatic brain metastasis lesions bigger than 2cm.
– Has Leptomeningeal disease.
– Ascites requiring drainage more than 1 time per month. Patients with PleurX catheters may be considered eligible after discussion and study medical monitor approval.
– Significant heart condition(s) (to be discussed in greater detail with research team and physician).
– Gastrointestinal disease causing inability to swallow oral study drug, or other significant gastrointestinal issues (to be discussed in greater detail with research team and physician).
– Has had a solid organ transplant.
– Known positive HIV (Subject may be eligible if they have no detectable viral load).
– Positive for hepatitis B or C.
– Female patients of childbearing potential, or male patients with partners that are of childbearing potential that are unwilling to use highly effective methods of contraception while on study are considered ineligible. Additionally, if patients agree to contraceptives, they must not donate eggs or sperm for a period of time from the first dose to 6 months after the last dose of study drug(s).
Additional exclusionary criteria may apply and are to be discussed in greater detail with the research team and physician.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
AMG 757 20240092: Phase 2 Study of Tarlatamab given as outpatient for patients with small cell lung cancer (SCLC).
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:
– Has a previous diagnosis of non-small cell lung cancer (NSCLC), including EGFR mutation positive NSCLC transformed into small cell lung cancer (SCLC).
– Symptomatic brain metastasis (Some exceptions apply. Can be discussed in greater detail with research team and physician).
– History of other cancer within the last 2 years (some exceptions apply, such as those felt to be low risk for recurrence as determined by your physician. Discuss with physician and research team for a detailed list of allowed exceptions).
– Has Leptomeningeal disease.
– Has lung disease or active pneumonitis.
– Active autoimmune disease that requires treatment within the last 2 years, or that requires immunosuppressive therapy while on study. (Replacement therapy is allowed)
– Has significant heart condition or history within the last 6 months prior to first dose of study drug.
– is HIV positive (patients with undetectable viral load are allowed to participate in study, as long as regular monitoring occurs to watch for reactivation).
– is Hepatitis B and C positive (Some may be eligible pending lab tests).
– Has had a major surgery within 21 days prior to first dose of study drug.
– Has received a live vaccine within the last 4 weeks prior to first dose.
Additional criteria may apply and should be discussed with the research team and physician.
Study Contact:
Lisa Wahowske
(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
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
