Overview

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.