Trials / Recruiting
RecruitingNCT05379985
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 754 (estimated)
- Sponsor
- Revolution Medicines, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
Detailed description
This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose \[RP2D\] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).
Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Advanced Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RMC-6236 | Oral Tablets |
Timeline
- Start date
- 2022-05-31
- Primary completion
- 2027-05-31
- Completion
- 2027-07-26
- First posted
- 2022-05-18
- Last updated
- 2025-11-12
Locations
16 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05379985. Inclusion in this directory is not an endorsement.