A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors
Merck Sharp & Dohme LLC
Summary
This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: For all participants: * Has measurable disease by RECIST 1.1 criteria * Has adequate organ function * Male participants agree to protocol-specified contraception requirements including refraining from donating sperm and using protocol-specified contraceptives unless confirmed to be azoospermic * Female participants must not be pregnant or breastfeeding, and must agree to protocol-specified contraceptive requirements and must have a negative highly sensitive pregnancy test within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study inte…
Interventions
- DrugCalderasib
Oral dose
- BiologicalPembrolizumab
Intravenous infusion of 200 mg
- Drugcarboplatin
Per label
- Drugpemetrexed
Per label
- Biologicalcetuximab
Per label
- Drugoxaliplatin
Per label
- Drugleucovorin
Per label
- Drug
Locations (74)
- Moffitt Cancer Center ( Site 0261)Tampa, Florida
- START Midwest ( Site 0267)Grand Rapids, Michigan
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)Hackensack, New Jersey
- Laura and Isaac Perlmutter Cancer Center ( Site 0270)New York, New York
- NEXT Virginia ( Site 0271)Fairfax, Virginia
- MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)Milwaukee, Wisconsin