A Phase 1/2 Study of LY3537982 in Patients with KRAS G12C-Mutant Advanced Solid Tumors

Brief description of study

Study LOXO-RAS-20001 is a first-in-human, multicenter, open-label Phase 1/2 study to evaluate the safety, tolerability, and preliminary efficacy of oral LY3537982 as monotherapy and as part of combination therapy in patients with KRAS G12C-mutant advanced solid tumor types, including but not limited to NSCLC and CRC. This study includes 2 parts, Phase 1a dose escalation (Part A) followed by a Phase 1b dose expansion (Part B-E). The Phase 1a dose escalation LY3537982 monotherapy cohort will enroll any eligible patient with KRAS G12C-mutant advanced solid tumor. Once the LY3537982 monotherapy RP2D (RP2DM) is established, Phase 1b dose expansion will begin and include 10 cohorts (NSCLC, Cohorts B1–B6; CRC, Cohorts C1–C2; other solid tumors [except NSCLC and CRC], Cohort D1; KRAS G12C-mutant advanced NSCLC who have previously been treated with a KRAS G12C inhibitor, Cohort E1) to further evaluate safety and clinical activity. KRAS G12C mutations will be identified through standard of care testing as routinely performed at each participating site utilizing material collected prior to patient consent to this protocol. Molecular assays utilized for enrollment are required to be performed in Clinical Laboratory Improvement Amendments (CLIA), International Organization for Standardization/International Electrotechnical Commission (ISO/IEC), College of American Pathologists (CAP), or other in a similarly certified laboratory.


Clinical Study Identifier: s21-00538
ClinicalTrials.gov Identifier: NCT04956640
Principal Investigator: Joshua K Sabari.
Other Investigators: Nila Theresa De La Rosa, Elaine Shum, Scot Niglio, Nitish Mehta, Vamsidhar Velcheti, Eneil De La Pena, Janice Mehnert, Laura Palazzolo, Kirby Rodriguez, Jessica Wang, Jonathan B Kahn, Danny Perlaza, Keriann M Scavone, Marissa Rybstein, Nina Beri, Avital Benson, Caitlin Elizabeth Ryan, David R. Wise, Elka R Travis, Salman Rafi Punekar, Sally Lau, Jeffrey G Schneider, Samantha VanMaanen, Kristen Spencer, James Newman, Kathleen M Madden, Nancy Chan, Douglas K Marks.


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