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

NCT05067283 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2030-02-25
Completion
2030-02-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • China
  • Denmark
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Malaysia
  • New Zealand
  • Panama
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067283 on ClinicalTrials.gov