Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care. The study will last up to approximately 2 years.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Loxo Oncology, Inc.
• Treatments: Cetuximab; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Patients have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

• Patients must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor deoxyribonucleic acid (DNA).

• Participants must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria.

• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

• Have adequate organ function.

• Have discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs).

• Must be able to swallow capsule/tablet.

• Agree and adhere to contraceptive use, if applicable.

Exclusion Criteria:

• Disease suitable for local therapy administered with curative intent.

• Have an active, ongoing, or untreated infection.

• Have a serious pre-existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.

• Have a serious cardiac condition.

• Have a second active primary malignancy or have been diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment.

• Have symptomatic central nervous system (CNS) malignancy or metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids in excess of 10 milligrams (mg) per day prednisone/prednisolone (or equivalent) and their disease is asymptomatic and radiographically stable for at least 30 days.

• Have received prior treatment with any KRAS G12C small molecule inhibitor, except in certain scenarios where such prior therapy is allowed as per protocol.

• For Cohorts B2, B3, and B5/C1, patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 (CYP)3A.

• The following patients will be excluded from Cohort B4:

• Experienced certain serious side effects with prior immunotherapy.

• Have an active autoimmune disease that has required systemic anti-autoimmune treatment in the past 2 years.

• Have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years.

• Have received a live vaccine within 30 days prior to the first dose of study drug.

• Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 180 days after the last dose of study medication.

• Known allergic reaction against any of the components of the study treatments.