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NCT05067283 · ClinicalTrials.gov registry record · Phase 1
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
A Phase 1 study of Advanced Solid Tumors, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 830
- Enrollment target
- 20
- Study locations
NCT05067283: Recruiting Phase 1 study of Advanced Solid Tumors, sponsored by Merck Sharp & Dohme.
NCT05067283 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 830 participants, above the 193-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (330% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05067283, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 830 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT will be reported.
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
| Field | Value |
|---|---|
| Enrollment Target | 830 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2030-02-25 |
| Phase | Phase 1 |
What NCT05067283 shows while recruiting
NCT05067283 is an interventional study that assigns participants to a tested intervention. The registered 830 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (330% higher).
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.
NCT05067283 names 20 study sites across 14 states, led by New South Wales, Ontario, Region M. de Santiago.
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.
What interventions are being tested in trial NCT05067283?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Calderasib (DRUG), carboplatin (DRUG), pemetrexed (DRUG), cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05067283?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05067283's enrollment target sits among peer trials
830 4th of 144 higher than 141 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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