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RECRUITING Phase 1

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

NCT05067283 · View on ClinicalTrials.gov ↗

Study Summary

This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.

Conditions Studied

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Calderasib
  • DRUG carboplatin
  • DRUG pemetrexed
  • BIOLOGICAL cetuximab

Study Locations (20)

New South Wales

  • Chris O'Brien Lifehouse ( Site 0002) — Camperdown
  • Liverpool Hospital-Medical Oncology ( Site 0001) — Liverpool
  • Westmead Hospital ( Site 0006) — Westmead

Ontario

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0030) — Hamilton
  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0036) — Kingston
  • Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0032) — Toronto

Region M. de Santiago

  • Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0041) — Santiago
  • FALP-UIDO ( Site 0040) — Santiago
  • Bradfordhill ( Site 0042) — Santiago

Florida

  • Moffitt Cancer Center ( Site 0261) — Tampa

Michigan

  • START Midwest ( Site 0267) — Grand Rapids

New Jersey

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0260) — Hackensack

New York

  • Laura and Isaac Perlmutter Cancer Center ( Site 0270) — New York

Virginia

  • NEXT Virginia ( Site 0271) — Fairfax

Trial Details

FieldValue
Enrollment Target 830 participants
Start Date 2021-12-17
Est. Completion 2030-02-25
Phase Phase 1

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05067283

The ClinicalTrials.gov registry entry for NCT05067283 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 830 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05067283 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New South Wales, Ontario, Region M. de Santiago. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05067283 about?

NCT05067283 is a clinical study titled "A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)". This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.

What is the current status of trial NCT05067283?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 830 participants. The study started on 2021-12-17. Estimated completion is 2030-02-25.

What conditions does trial NCT05067283 study?

This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05067283?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Calderasib (DRUG), carboplatin (DRUG), pemetrexed (DRUG), cetuximab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05067283?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05067283 being conducted?

This trial has 20 study locations across Florida, Michigan, New Jersey, New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial