18-BI-1206-03: Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody CD32b (FcƴRIIB) in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors Previously Treated with Anti-PD-1 or Anti-PD-L1 Antibodies
Principal Investigator: Yan Ji, MD
Study Sponsor: BioInvent International AB
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if a medicine not yet approved by the FDA, named BI-1206, will help in the treatment of advanced solid tumors and also how safe it is for people to use in combination with pembrolizumab, which is an approved drug under the trade name of Keytruda.
There are 2 parts to this study: Part 1 (dose escalation) Part 2 (dose expansion). When enrollment is completed to Part 1 then Part 2 (dose expansion) will open.
Inclusion Criteria:
– At least 18 years of age on day of signing informed consent.
– Has a histologically confirmed advanced solid tumor.
– Must have received at least 2 doses of an approved anti-PD-1/L1 mAb administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
– Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
– Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206 (on non-previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor-directed therapy.
– Has an ECOG performance status of 0-1.
– Has adequate organ function as confirmed by laboratory values.
– Has a life expectancy of at least 12 weeks.
Exclusion Criteria:
– Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
– Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated CNS metastases may participate provided they are radiologically stable.
– Has cardiac or renal amyloid light-chain amyloidosis.
– Has received chemotherapy or small molecule products within 4 weeks of first dose of BI-1206.
– Has received radiotherapy within 2 weeks of first dose of BI-1206.
– Has received immunotherapy within 4 weeks prior to the first dose of BI-1206.
– Has an active, known or suspected autoimmune disease.
– Has had an allogenic tissue/solid organ transplant.
– Has uncontrolled or significant cardiovascular disease.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
AK112-301: A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi).
Principal Investigator: Kurt Demel, MD
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 study is randomized, meaning you have an equal chance to be placed in either the study drug arm, or the placebo arm. The study is split into two arms: Arm 1 is the study drug (Ivonescimab, or AK112) combined with the drugs Pemetrexed and Carboplatin. Arm 2 is Placebo combined with Pemetrexed and Carboplatin. Since both arms are receiving Pemetrexed and Carboplatin, you will still be receiving some form of treatment for your disease regardless of what arm you are assigned. The main purpose of the study is to compare the overall survival and progression-free survival between the two arms. The study drug is an antibody. Antibodies are substances that occur naturally in the body and help fight infection. The study drug blocks two proteins in the body that help cancer cells live, grow, and spread. It is possible that the study drug may slow the growth and spread of cancer cells.
Inclusion Criteria:
– Must sign written informed consent.
– Must be at least 18 years old at the time of consent.
– ECOG of 0 – 1.
– Expected survival of at least 3 months.
– Confirmed locally advanced (stage IIIB / IIIC) or metastatic (stage IV) non-squamous non-small cell lung cancer.
– EGFR mutation as confirmed by tumor testing.
– Prior treatment with EGFR TKIs and treatment failure.
– At least 1 measurable noncerebral lesion per RECIST 1.1.
– Adequate organ function as determined by local lab tests.
– Negative serum pregnancy test within 3 days prior to first dose for women of child-bearing potential (WOCBP).
– WOCBP and their partners must agree to highly effective contraceptive use during the duration of the study and for at least 120 days following the last dose.
– Additional criteria may apply and will be discussed with the physician and research team.
Additional inclusion criteria may apply and will be discussed in greater detail with research team and physician.
Exclusion Criteria:
– Evidence of small cell carcinoma component, or predominantly squamous cell carcinoma.
– Previously received immunotherapy including anti-PD-1/PD-L1 antibodies, anti-CTLA4, and immune-checkpoint agonists, immune cell therapy.
– Received systemic antitumor therapy or antiangiogenic therapy other than EGFR inhibitors.
– Enrolled in another clinical trial, unless it is a non-interventional study or the follow-up period of an interventional study, and is more than 4 weeks from the last dose of the prior clinical study drug administration.
– Received EGFR inhibitor therapy within 2 weeks prior to first dose.
– Imaging during the screening period showing tumor growth around important blood vessels, that in the physician’s opinion could be a concern for bleeding risks.
– Symptomatic brain metastases.
– Other malignant tumors besides NSCLC within 3 years prior to first dose.
– Active autoimmune disease requiring systemic therapy within 2 prior to first dose. *Replacement therapy such as insulin or corticosteroid replacement therapy (prednisone <10mg per day or equivalent) for adrenal or pituitary insufficiency is allowed.
– History of major diseases within 1 year before first dose
– Major surgical procedures or severe infections within 4 weeks prior to first dose.
– History of severe bleeding.
– Current hypertension, uncontrolled hyperglycemia, presence of pleural effusions, pericardial effusions, ascites requiring multiple drainage, history of noninfectious pneumonia,
– Active or history of IBD (such as Crohn’s disease, ulcerative colitis)
– History of immunodeficiency; HIV test positive.
– History of Allogenic organ transplant or hematopoietic stem cell transplant.
– Untreated Hepatitis B, active Hepatitis C
– Known active tuberculosis
– Active Syphilis
– Unresolved toxicities from previous treatments that have not returned to baseline.
– Other exclusion 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
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
Principal Investigator: Kurt Demel, MD
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
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).
Principal Investigator: Yan Ji, MD
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
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.
Principal Investigator: Dylan Zylla, MD
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
RGX-104-001: A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies (RGX-104-001)
Principal Investigator: Arkadiusz Dudek, PhD, MD
Study Sponsor: Rgenix, Inc. , Inc.
Location: HealthPartners Frauenshuh Cancer Center, HealthPartners Cancer Center at Regions Hospital
Phase of Study: Phase 1
Purpose of study: The purpose of the study is to see if the experimental drug called RGX-104 used in combination with docetaxel, will help in the treatment of small cell lung cancer (SCLC). We are also testing RGX-104 in combination with pembrolizumab, carboplatin, and pemetrexed in patients with non-small cell lung cancer (NSCLC). We are trying to find the best dose to use that will benefit patients with SCLC or NSCLC.
Inclusion Criteria:
For patients with NSCLC enrolled in the pembrolizumab plus carboplatin/pemetrexed combination dose escalation or expansion stages:
- The patient must have histologic or cytologic evidence of newly-diagnosed non-squamous, NSCLC that is advanced disease, defined as cancer that is either metastatic (Stage 4) or locally advanced (Stage 3B) and unresectable.
- The patient has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
- The patient has not received prior systemic treatment for their advanced/metastatic disease.
- For patients in the expansion stage only: the patient’s tumor block must demonstrate PD-L1 expression TPS <1% as determined with a validated assay.
- The patient must have adequate organ function and performance status eligible for treatment with a platinum-based regimen and checkpoint inhibitor.
For patients with SCLC enrolled in the docetaxel combination expansion stage:
- The patient must have a pathologically confirmed (by histology or cytology) diagnosis of SCLC, which is currently extensive disease (disease outside a single radiation port), or of metastatic neuroendocrine cancer with small cell or high-grade features. Patients with metastatic neuroendocrine cancer with small cell or high-grade features must have a pathology report supplied to the sponsor before treatment.
- The patient must have demonstrated disease progression following platinum-based chemotherapy with or without a PD-1/L1 inhibitor for SCLC, or following a different, acceptable first-line regimen for high-grade neuroendocrine tumors.
- The patient must have received no more than 1 prior line of therapy for extensive disease.
Patients enrolled in the expansion stages must agree to a tumor biopsy to be obtained during the screening period and toward the beginning of Cycle 2 or at the time of PD, if earlier.
Patients must have disease that is measurable.
Patients must be ≥18 years old.
Patients must have a normal left ventricular ejection fraction as measured by an ECHO or MUGA
Additional criteria may apply.
Exclusion Criteria:
- Has persistent clinically significant toxicities (Grade ≥2) from previous anticancer therapy (excluding Grade 2 chemotherapy-related neuropathy and alopecia which are permitted). Prior toxicities that resulted in laboratory abnormalities should have resolved to Grade ≤1, unless a higher-grade abnormality is allowed by the inclusion criteria. If medical therapy is required for the treatment of a laboratory abnormality, the dose and laboratory value(s) should be stable.
- Has received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study therapy administration
- Has received treatment with an investigational systemic anticancer agent within 14 days prior to study therapy administration.
- Has previously received treatment with RGX-104 or another investigational agent that is a known LXR agonist.
- Has clinically significant cardiovascular disease or uncontrolled, clinical significant pulmonary disease.
- Has known active or suspected brain or leptomeningeal metastases.
- Additional criteria may apply.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com