Trials / Recruiting
RecruitingNCT05067283
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
A Phase 1, Open-label, Multicenter Study to Assess Safety, Tolerability, PK, and Efficacy of MK-1084 as Monotherapy and as Part of Various Combination Therapies in Participants With KRAS G12C Mutant Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 830 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Calderasib | Oral dose |
| BIOLOGICAL | Pembrolizumab | Intravenous infusion of 200 mg |
| DRUG | carboplatin | Per label |
| DRUG | pemetrexed | Per label |
| BIOLOGICAL | cetuximab | Per label |
| DRUG | oxaliplatin | Per label |
| DRUG | leucovorin | Per label |
| DRUG | 5-fluorouracil | Per label |
Timeline
- Start date
- 2021-12-17
- Primary completion
- 2030-02-25
- Completion
- 2030-02-25
- First posted
- 2021-10-05
- Last updated
- 2026-02-12
Locations
73 sites across 21 countries: United States, Argentina, Australia, Canada, Chile, China, Denmark, Israel, Italy, Japan, Lithuania, Malaysia, New Zealand, Panama, Poland, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05067283. Inclusion in this directory is not an endorsement.