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ACTIVE NOT RECRUITING Phase 1

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

NCT05462717 · View on ClinicalTrials.gov ↗

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.

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

66 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Revolution Medicines, which has 66 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05462717 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, New York, Victoria. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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, Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05462717?

The interventions under investigation include: RMC-6291 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05462717?

This trial is sponsored by Revolution Medicines, which has 66 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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