Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
18 Years and older, Male and Female
LOXO-RAS-20001 (primary)
NCI-2021-09724
2021-000595-12
2022-502756-31-00
J3M-OX-JZQA
KEYNOTE E27
MK-3475-E27/KEYNOTE E27
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, except for
specific groups who have not had cancer treatment. The study will last up to
approximately 4 years.
Objectives
This is an open-label, multicenter Phase 1/2 study to evaluate safety, tolerability, and
preliminary efficacy of oral LY3537982 in patients with KRAS G12C-mutant solid tumors.
This study will be conducted in 4 parts: Phase 1a dose escalation, Phase 1b dose
expansion, Phase 1b dose optimization, and Phase 2. KRAS G12C mutations will be
identified through standard of care testing.
Eligibility
- 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), (except in certain scenarios).
- Must be able to swallow capsule/tablet.
- Agree and adhere to contraceptive use, if applicable.
- For some parts of the study, (i.e., one of the two arms with LY3537982 in combination with pembrolizumab and the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy) histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC that is previously untreated in the advanced/metastatic setting and not suitable for curative intent radical surgery or radiation therapy. Previously untreated patients who received adjuvant and neoadjuvant therapy are eligible if the last dose of the systemic treatment was completed at least 6 months prior to enrollment. For untreated patients in the arm with LY3537982 in combination with pembrolizumab noted above, a single cycle of pembrolizumab may be initiated within 21 days prior to enrollment. For untreated patients in the arm of LY3537982 in combination with pembrolizumab, pemetrexed, and platinum therapy, a single cycle of any or all of the drugs other than LY3537982 may be initiated within 21 days prior to enrollment. Start of study treatment may be delayed to allow sufficient time for recovery from treatment-related toxicity.
- For one part of the study, participants must have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC.
Treatment Sites in Georgia
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