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Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
EU CTIS ID: 2022-502756-31-00
What this study is testing
"To identify the RP2D, safety and tolerability, optimal dose, and antitumor activity of LY3537982, administered as monotherapy and in combination with other anticancer therapies, in patients with KRAS G12C-mutant advanced solid tumors"
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Individuals must be able to provide consent consistent with local regulations and be ≥ 18 years of age at the time of signing the informed consent form
- Individuals must have measurable disease per RECIST v1.1
- Individuals must have a solid tumor with a KRAS G12C mutation. Individuals with NSCLC who have progressed on a prior KRAS G12C inhibitor are allowed to enroll but must have KRAS G12C mutation confirmed on a blood or tumor sample collected within 3 months of discontinuing the KRAS G12C inhibitor.
- "Phase 1a Dose escalation: - Advanced solid tumor - Patients who are not candidates for approved treatment measures Phase 1b Dose expansion Part B: - Cohort B9: Individuals must have previously untreated advanced/metastatic NSCLC. One prior 21-day cycle of the KEYNOTE-189 regimen is allowed before enrollement. Patients must initiate study treatment at the dose levels specified for each planned combination agent. - Cohort B8: Individuals must have at least 1 untreated, active brain metastasis Phase 1b Dose expansion Part C and Dose Optimization Part H: - Individuals must have received at least one prior oxaliplatin or irinotecan-containing regimen for advanced/metastatic CRC Phase 1b Dose expansion Part D - Individuals must have an unresetable solid tumor with a KRAS G12C mutation that is not NSCLC, CRC, or pancreatic cancer Phase 1b Dose expansion Part E - Individuals must have been previously treated with a KRAS G12C inhibitor Phase 2 Part F - Individuals must have unresectable pancreatic cancer with a KRAS G12C mutation Phase 1b Dose Optimization Part G - Individuals must have previously untreated advanced/metastatic NSCLC. One prior 21-day cycle of pembrolizumab is allowed before enrollement.
- Individuals must have an ECOG performance status of 0 or 1
- Individuals must have adequate organ function, as measured by blood tests
You likely can't join if
- Individual must not have an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process.
- Individuals cannot have a second active primary malignancy.
- Individuals cannot have untreated active CNS metastases and/or carcinomatous meningitis. This does not apply to cohort B8.
- Individuals cannot have received prior KRAS G12C inhibitor therapy. This does not apply to Phase 1a Dose Escalation backfill, cohort E1, or cohort B4.
- Individuals that have experienced certain immune-related adverse reactions cannot enroll to cohorts B4, B9, or Part G.
- "Individuals with the following cannot enroll to cohorts B4, B9, or Part G: - An active autoimmune disease - Received a live vaccine within 30 days of study treatment - Received an organ or tissue transplant - Received radiation treatment to lungs - Received prior systemic therapy (except as allowed in Inclusion Criteria #4) "
See the full eligibility criteria
Who can join
- Individuals must be able to provide consent consistent with local regulations and be ≥ 18 years of age at the time of signing the informed consent form
- Individuals must have measurable disease per RECIST v1.1
- Individuals must have a solid tumor with a KRAS G12C mutation. Individuals with NSCLC who have progressed on a prior KRAS G12C inhibitor are allowed to enroll but must have KRAS G12C mutation confirmed on a blood or tumor sample collected within 3 months of discontinuing the KRAS G12C inhibitor.
- "Phase 1a Dose escalation: - Advanced solid tumor - Patients who are not candidates for approved treatment measures Phase 1b Dose expansion Part B: - Cohort B9: Individuals must have previously untreated advanced/metastatic NSCLC. One prior 21-day cycle of the KEYNOTE-189 regimen is allowed before enrollement. Patients must initiate study treatment at the dose levels specified for each planned combination agent. - Cohort B8: Individuals must have at least 1 untreated, active brain metastasis Phase 1b Dose expansion Part C and Dose Optimization Part H: - Individuals must have received at least one prior oxaliplatin or irinotecan-containing regimen for advanced/metastatic CRC Phase 1b Dose expansion Part D - Individuals must have an unresetable solid tumor with a KRAS G12C mutation that is not NSCLC, CRC, or pancreatic cancer Phase 1b Dose expansion Part E - Individuals must have been previously treated with a KRAS G12C inhibitor Phase 2 Part F - Individuals must have unresectable pancreatic cancer with a KRAS G12C mutation Phase 1b Dose Optimization Part G - Individuals must have previously untreated advanced/metastatic NSCLC. One prior 21-day cycle of pembrolizumab is allowed before enrollement.
- Individuals must have an ECOG performance status of 0 or 1
- Individuals must have adequate organ function, as measured by blood tests
- Individuals must have stopped all previous cancer treatments and recovered from the major side effects
What rules you out
- Individual must not have an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process.
- Individuals cannot have a second active primary malignancy.
- Individuals cannot have untreated active CNS metastases and/or carcinomatous meningitis. This does not apply to cohort B8.
- Individuals cannot have received prior KRAS G12C inhibitor therapy. This does not apply to Phase 1a Dose Escalation backfill, cohort E1, or cohort B4.
- Individuals that have experienced certain immune-related adverse reactions cannot enroll to cohorts B4, B9, or Part G.
- "Individuals with the following cannot enroll to cohorts B4, B9, or Part G: - An active autoimmune disease - Received a live vaccine within 30 days of study treatment - Received an organ or tissue transplant - Received radiation treatment to lungs - Received prior systemic therapy (except as allowed in Inclusion Criteria #4) "
- Patients with measured or calculated creatinine clearance <45mL/min at Cycle 1 Day 1 or withing 48 hours of C1D1 are excluded from Cohort B9
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
- Japan
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of; Japan; Australia; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.