Trials / Active Not Recruiting
Active Not RecruitingNCT05462717
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 222 (estimated)
- Sponsor
- Revolution Medicines, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
Detailed description
This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Ductal Adenocarcinoma
- Advanced Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RMC-6291 | Oral tablet once or twice a day |
Timeline
- Start date
- 2022-09-19
- Primary completion
- 2027-03-31
- Completion
- 2027-09-30
- First posted
- 2022-07-18
- Last updated
- 2026-04-08
Locations
64 sites across 13 countries: United States, Australia, Czechia, France, Italy, Malaysia, Poland, Serbia, Singapore, South Korea, Spain, Taiwan, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05462717. Inclusion in this directory is not an endorsement.