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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 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.

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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.

Conditions Studied

Advanced Solid Tumor Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC)

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

FieldValue
Enrollment Target 222 participants
Start Date 2022-09-19
Est. Completion 2025-12
Phase Phase 1

Sponsor

Revolution Medicines

16 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05462717

The ClinicalTrials.gov registry entry for NCT05462717 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (16% higher). The listed sponsor is Revolution Medicines, which has 16 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.