Trials / Recruiting
RecruitingNCT06040541
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 604 (estimated)
- Sponsor
- Revolution Medicines, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.
Detailed description
This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.
Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Advanced Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RMC-9805 | Oral Tablets |
| DRUG | RMC-6236 | Oral Tablets |
Timeline
- Start date
- 2023-09-07
- Primary completion
- 2026-04-30
- Completion
- 2027-04-30
- First posted
- 2023-09-15
- Last updated
- 2025-08-28
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06040541. Inclusion in this directory is not an endorsement.