A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Phase 1 Recruiting 830 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2021-12-17
Primary completion: 2030-02-25
Completion: 2030-02-25

Publications

Ma X, Sloman DL, Duggal R, Anderson KD, Ballard JE, Bharathan I, Brynczka C, Gathiaka S, Henderson TJ, Lyons TW, Miller R, Munsell EV, Orth P, Otte RD, Palani A, Rankic DA, Robinson MR, Sather AC, Solban N, Song XS, Wen X, Xu Z, Yang Y, Yang R, Day PJ, Stoeck A, Bennett DJ, Han Y. Discovery of MK-1084: An Orally Bioavailable and Low-Dose KRASG12C Inhibitor. J Med Chem. 2024 Jul 11;67(13):11024-11052. doi: 10.1021/acs.jmedchem.4c00572. Epub 2024 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calderasib	Unknown	800 mg	Oral
Subject	Cetuximab	Monoclonal antibody	—	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	—	—
Background	Leucovorin	Small molecule	—	—
Background	Oxaliplatin	Small molecule	—	—
Background	Pemetrexed	Small molecule	—	—
Background	fluorouracil	Small molecule	—	—

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Summary

Timeline

Publications

Drugs

Indications