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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment150 people
  • Recruiting US sites6
  • SponsorMerck Sharp & Dohme LLC
  • RegistryNCT07209111

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014): a one-minute explainerNCT072091111 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Kras G12C inhibitor MK-1084. An orally available inhibitor of the oncogenic KRAS substitution mutation G12C, with potential antineoplastic activity. Upon oral administration, KRAS G12C inhibitor MK-1084 selectively targets the KRAS G12C mutant and inhibits KRAS G12C-mediated signaling. This may halt proliferation and metastasis in susceptible tumor cells. KRAS, a member of the RAS family of oncogenes, serves an important role in cell signaling, division and differentiation. Mutations of KRAS may induce constitutive signal transduction leading to tumor cell proliferation, invasion, and metastasis. NCI Drug Dictionary

cetuximab. A recombinant, chimeric monoclonal antibody directed against the epidermal growth factor (EGFR) with antineoplastic activity. Cetuximab binds to the extracellular domain of the EGFR, thereby preventing the activation and subsequent dimerization of the receptor; the decrease in receptor activation and dimerization may result in an inhibition in signal transduction and anti-proliferative effects. This agent may inhibit EGFR-dependent primary tumor growth and metastasis. EGFR is overexpressed on the cell surfaces of various solid tumors. NCI Drug Dictionary

Treatments listed in the registry

  • Calderasib (Drug): Oral administration
  • Cetuximab (Biological): Intravenous administration

The study

Treatment groups

Randomized · Parallel · masking: None

Calderasib (Experimental)

Participants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Calderasib + Cetuximab (Experimental)

Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.

Goals

What the study measures

Main goals

  • Objective Response Rate (ORR) (Up to approximately 76 months)
  • Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 76 months)
  • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 76 months)

Other goals

  • Progression-free Survival (PFS)
  • Duration of Response (DOR)
  • Overall Survival (OS)

Planned enrollment: 150 (estimated).

Where

Recruiting US sites

  • Greater Baltimore Medical Center ( Site 1104), Baltimore, Maryland
  • START Midwest ( Site 1103), Grand Rapids, Michigan
  • Comprehensive Cancer Centers of Nevada ( Site 1109), Las Vegas, Nevada
  • Rutgers Cancer Institute of New Jersey ( Site 1100), New Brunswick, New Jersey
  • START Mountain Region ( Site 1106), West Valley City, Utah
  • Virginia Cancer Specialists ( Site 1102), Fairfax, Virginia

66 recruiting sites outside the US. Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 6, 2026. Public record; not medical advice.

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