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RecruitingLast updated: 23 April 2026

KANDLELIT-014: Assessing targeted medicines for the treatment of advanced solid cancers with a KRAS G12C mutationA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

KANDLELIT-014

Clinical summary

Summary

Researchers want to learn if a medicine called calderasib targeted therapy given alone, or with cetuximab targeted therapy, can treat certain advanced solid tumours in people with the KRAS G12C mutation. 

You may be eligible if you have a locally advanced, unresectable, or metastatic solid cancer (excluding colorectal cancer) that has progressed on, or after, standard of care systemic treatment. Your cancer should have the KRAS G12C mutation.

The goal of this study are to learn:

  • How many people have the cancer respond (get smaller or go away) when treated with calderasib alone or with cetuximab, and how these responded compare.
  • About the safety of calderasib alone or with certuximab, and if people tolerate the treatments.

Eligible participants will be randomly allocated (by chance) to receive one of two treatments:

  • Calderasib alone, as an oral tablet.
  • Calderasib orally plus cetuximab intravenous (IV) infusion.

Conditions

This trial is treating people with solid cancers (excluding bowel cancer) with a KRAS G12C mutation

Eligibility

Inclusion

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

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

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07209111 *
  • 2025-521737-91-00 *
  • 1084-014; MK-1084-014; U1111-1320-8626; JRCT2031250825

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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)

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