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A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
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)
Who can join
Ages 18 and older · All sexes
Full eligibility 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
About the study
Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
The goals of this study are to learn:
* How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare * About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.
What is being tested
- Calderasib (drug)
- Cetuximab (biological)
Sponsor: Merck Sharp & Dohme LLC · Participants: 150 · Started: Dec 4, 2025
Contact the study team
- Toll Free Number · Phone: 1-888-577-8839
Official record on ClinicalTrials.gov — NCT07209111
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.