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2022-09-19
2024-11
2025-12
222
NCT05462717
Revolution Medicines, Inc.
Revolution Medicines, Inc.
INTERVENTIONAL
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-07-11 | N/A | 2024-11-05 |
2022-07-13 | N/A | 2024-11-07 |
2022-07-18 | N/A | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: RMC-6291 Dose Escalation and Dose Expansion | DRUG: RMC-6291
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Adverse events | Number of participants with adverse events | up to 3 years |
| Dose Limiting Toxicities | Number of participants with dose limiting toxicities | The first 21 days (i.e. Cycle 1) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum Observed Blood Concentration of RMC-6291 | Cmax | 7 Cycles |
| Time to Reach Maximum Blood Concentration of RMC-6291 | Tmax | 7 Cycles |
| Area Under Blood Concentration Time Curve of RMC-6291 | AUC | 7 Cycles |
| Elimination Half-Life of RMC-6291 | t1/2 | 7 Cycles |
| Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing | accumulation ratio | 7 Cycles |
| Overall Response Rate (ORR) | Overall response rate per RECIST v1.1 | 3 years |
| Duration of Response (DOR) | Duration of response per RECIST v1.1 | 3 years |
| Disease Control Rate (DCR) | Disease control rate per RECIST v1.1 | 3 years |
| Time to Response (TTR) | Time to response per RECIST v1.1 | 3 years |
| Progression-Free Survival (PFS) | Progression-free survival per RECIST v1.1 | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
