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RecruitingInterventionalPhase 2

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)

NCT ID: NCT07209111Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-12

Summary

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.

Arms & interventions

  • DrugCalderasib

    Oral administration

  • BiologicalCetuximab

    Intravenous administration

Outcome measures

Primary

  • Objective Response Rate (ORR)

    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.

    Time frame: Up to approximately 76 months

  • Number of Participants Who Experience One or More Adverse Events (AEs)

    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.

    Time frame: Up to approximately 76 months

  • Number of Participants Who Discontinue Study Treatment Due to an AE

    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.

    Time frame: Up to approximately 76 months

Secondary

  • Progression-free Survival (PFS)

    Time frame: Up to approximately 76 months

  • Duration of Response (DOR)

    Time frame: Up to approximately 76 months

  • Overall Survival (OS)

    Time frame: Up to approximately 76 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (6)

Greater Baltimore Medical Center ( Site 1104)

Baltimore, Maryland, 21204

Recruiting
Study Coordinator · Contact

START Midwest ( Site 1103)

Grand Rapids, Michigan, 49546

Recruiting
Study Coordinator · Contact

Comprehensive Cancer Centers of Nevada ( Site 1109)

Las Vegas, Nevada, 89169

Recruiting
Study Coordinator · Contact

Rutgers Cancer Institute of New Jersey ( Site 1100)

New Brunswick, New Jersey, 08903

Recruiting
Study Coordinator · Contact

START Mountain Region ( Site 1106)

West Valley City, Utah, 84119

Recruiting
Study Coordinator · Contact

Virginia Cancer Specialists ( Site 1102)

Fairfax, Virginia, 22031

Recruiting
Study Coordinator · Contact
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) | Cancerify