A Phase II, 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)

Study Identifier:
MK-1084-014
CT.gov Identifier:
NCT07209111
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-521737-91-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

Evaluating the efficacy and safety of MK-1084 and MK-1084 in combination with Cetuximab in patients with advanced solid tumors harboring KRAS G12C mutations.

To evaluate calderasib as monotherapy and in combination with cetuximab for certain patients with KRAS G12C-mutant advanced solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • Patients with locally advanced unresectable or metastatic solid malignancies other than colorectal cancer, whose disease has progressed during or after systemic SOC therapy, or who have no satisfactory alternative treatment options.
    • KRAS G12C mutation detected in tumor tissue
    • ECOG fitness status assessment: 0 or 1
    • There are measurable lesions (eligible to be selected as target lesions) as determined by RECIST 1.1.
    • Having sufficient organ function as defined in the plan
    • There are no Gender restrictions, and Age be at least 18 years old when providing informed consent.
    • The male subjects met the contraceptive requirements specified in the protocol.
    • The female participants met the contraceptive requirements specified in the protocol.
    • Based on the researchers' assessment, it is reasonably expected that they can comply with the research requirements for at least 3 months.
    • Subjects who experienced adverse events (AEs) due to prior anti-tumor therapy must have recovered to grade ≤1 or baseline level.
    • HIV/HBV/HCV infection should be adequately controlled.
    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
    • Oral medications that cannot be swallowed
    • Suffering from uncontrolled, significant cardiovascular or cerebrovascular disease
    • He has a known history of other malignant tumors that are progressing or require aggressive treatment within the past 3 years.
    • Known active CNS metastases, carcinomatous meningitis, and/or primary brain tumor.
    • Not fully recovered from major surgery, or still experiencing ongoing surgical complications.
    • Those who have previously received drug therapy targeting KRAS mutations or have previously received anti-EGFR mAb therapy
    • Active infection requiring systemic treatment
    • The researchers believe that any past or present conditions, treatments, abnormal laboratory tests, or other circumstances that could obscure the research results or interfere with the participant's ability to comply with research requirements would not be in the best interest of the participant.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer