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

Detailed criteria

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

Drug
Calderasib
Oral dose
Biological
Pembrolizumab
Intravenous infusion of 200 mg
Drug
carboplatin
Per label
Drug
pemetrexed
Per label
Biological
cetuximab
Per label
Drug
oxaliplatin
Per label
Drug
leucovorin
Per label
Drug
5-fluorouracil
Per label

Locations (75)

Moffitt Cancer Center ( Site 0261)
Tampa, Florida
813-745-5995
START Midwest ( Site 0267)
Grand Rapids, Michigan
616-954-5554
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260)
Hackensack, New Jersey
551-996-5900
Laura and Isaac Perlmutter Cancer Center ( Site 0270)
New York, New York
NEXT Virginia ( Site 0271)
Fairfax, Virginia
703-280-5390
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0262)
Milwaukee, Wisconsin
414-805-0505