Home › Trials › NCT07209111

Calderasib (MK-1084) with or without cetuximab for advanced KRAS G12C solid tumors

A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination With Cetuximab, in Participants With KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)

Phase 2 Interventional Merck Sharp & Dohme LLC · NCT07209111

This study will test whether calderasib (MK-1084), alone or combined with cetuximab, can shrink advanced solid tumors in people whose cancers have the KRAS G12C mutation.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionscetuximab
Locations55 sites (Baltimore, Maryland and 54 other locations)
Trial IDNCT07209111 on ClinicalTrials.gov

What this trial studies

This is a phase 2, multicenter interventional study enrolling people with locally advanced or metastatic non-colorectal solid tumors that harbor the KRAS G12C mutation. Participants receive calderasib alone or calderasib plus cetuximab and are followed for tumor response and safety. The main goals are to compare how often tumors shrink or disappear with each approach and to document tolerability and adverse effects. Study visits and treatments occur at participating U.S. cancer centers.

Who should consider this trial

Good fit: Ideal candidates are adults with locally advanced unresectable or metastatic non-colorectal solid tumors that have progressed after standard systemic therapy and whose tumors test positive for the KRAS G12C mutation, without active brain metastases or uncontrolled cardiovascular disease.

Not a fit: Patients without the KRAS G12C mutation, those with colorectal cancer, active central nervous system metastases, uncontrolled cardiovascular disease, or recent other progressing malignancies are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination or single-agent calderasib could offer a new treatment option that shrinks tumors or controls disease in patients with KRAS G12C–mutant cancers.

How similar studies have performed: Other KRAS G12C inhibitors have shown tumor responses in lung and some other cancers, and combining KRAS G12C inhibitors with EGFR-targeted drugs has been explored, but calderasib plus cetuximab remains a relatively new combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
* Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
* Has active infection, other than those permitted per protocol, requiring systemic therapy
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where this trial is running

Baltimore, Maryland and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neoplasm MalignantKRASNSCLCCRCTumor-agnosticPan TumorKRAS G12C
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.