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NCT05462717 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
A Phase 1 study of Advanced Solid Tumor and Pancreatic Ductal Adenocarcinoma, sponsored by Revolution Medicines.
- Active
- Registry status
- Phase 1
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT05462717: Active Phase 1 study of Advanced Solid Tumor and Pancreatic Ductal Adenocarcinoma, sponsored by Revolution Medicines.
NCT05462717 is a Phase 1 study of Advanced Solid Tumor and Pancreatic Ductal Adenocarcinoma that is active but no longer recruiting, run by Revolution Medicines. The registered enrollment target is 222 participants, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (16% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05462717, a Phase 1 study of Advanced Solid Tumor and Pancreatic Ductal Adenocarcinoma, is active but no longer recruiting, sponsored by Revolution Medicines.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Number of participants with adverse events
Conditions Studied
Interventions
- DRUG RMC-6291
Study Locations (20)
California
- UC Irvine Cancer Center - Orange
- UC Davis Cancer Center - Sacramento
- UCSF - San Francisco
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- MSK Cancer Center - New York
- Columbia University Irving Medical Center - New York
Victoria
- Peninsula & South Eastern Haematology and Oncology Group - Frankston
- Austin Health, Olivia Newton-John Cancer Research & Wellness Centre - Heidelberg
- South West Health Care - Warrnambool
Florida
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center - Miami
- Moffitt Cancer Center - Tampa
Texas
- Next Oncology - San Antonio
- START - San Antonio
Arkansas
- Highlands Oncology Group - Springdale
Maryland
- American Oncology Partners of Maryland - Bethesda
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2025-12 |
| Phase | Phase 1 |
What the registry record for NCT05462717 still lists
NCT05462717 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (16% higher).
The record links to 4 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which RMC-6291 is the first listed.
NCT05462717 names 20 study sites across 12 states, led by California, New York, Victoria.
Frequently Asked Questions
What is clinical trial NCT05462717 about?
NCT05462717 is a clinical study titled "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.
What is the current status of trial NCT05462717?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 222 participants. The study started on 2022-09-19. Estimated completion is 2025-12.
What conditions does trial NCT05462717 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC).
What interventions are being tested in trial NCT05462717?
The interventions under investigation include: RMC-6291 (DRUG).
Who is sponsoring clinical trial NCT05462717?
This trial is sponsored by Revolution Medicines, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05462717 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05462717's enrollment target sits among peer trials
222 54th of 189 higher than 136 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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