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Calderasib for Advanced Solid Tumors with KRAS G12C Mutation

This study is looking into whether a drug called calderasib, given alone or with another drug called cetuximab, can help people with advanced solid tumors that have a specific genetic change called a KRAS G12C mutation. You might be able to join if you have a locally advanced or metastatic solid tumor (cancer that has spread) other than colorectal cancer, and your cancer has worsened after standard treatments. Researchers want to see how many people's tumors shrink or disappear, and also understand the safety and side effects of these treatments. The study aims to enroll about 150 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 150 participants. It is testing calderasib, given by mouth, and cetuximab, given intravenously (through a vein).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and how well the treatment works for up to approximately 76 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07209111

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

Recruiting
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~150 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:CalderasibCetuximab

At a glance

Recruiting sites
71 of 71 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to approximately 76 months
+2 more outcomes measured

Conditions

Neoplasm Malignant

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaSolid NeoplasmGTPase KRas

Where it's being run

71 sites across 49 states
Turkey (Türkiye)5
Region M. de Santiago4
Shanghai Municipality3
Israel3
South Korea3
Spain3
New South Wales2
Guangdong2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Objective Response Rate (ORR)Up to approximately 76 months

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

  • Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 76 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be reported.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 76 months

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be reported.