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Clinical Trials in the USA / NCT05462717
Active, not recruiting Phase 1

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

NCT05462717 · tracked via the Priya Life Science USA tracker
Sponsor
Revolution Medicines, Inc.
Phase
Phase 1
Started
2022-09-19
Last updated
2026-05-15

Condition(s) studied

Non-Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal AdenocarcinomaAdvanced Solid Tumor

Investigational drug(s) / intervention(s)

RMC-6291

RMC-6291: Oral tablet once or twice a day

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Subject must be ≥18 years of age. * Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments. * ECOG performance status 0 or 1 * Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation and for NSCLC in dose expansion * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active brain metastases * Known impairment of GI function that would alter the absorption * Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment. * Prior therapy with KRASG12C (ON) inhibitor Other inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Highlands Oncology Group Springdale Arkansas
UC Irvine Cancer Center Orange California
UC Davis Cancer Center Sacramento California
UCSF San Francisco California
University of Miami School of Medicine Sylvester Comprehensive Cancer Center Miami Florida
Moffitt Cancer Center Tampa Florida
American Oncology Partners of Maryland Bethesda Maryland
Dana-Farber Cancer Institute Boston Massachusetts
Roswell Park Comprehensive Cancer Center Buffalo New York
MSK Cancer Center New York New York
Columbia University Irving Medical Center New York New York
Tennessee Oncology Nashville Tennessee
Next Oncology San Antonio Texas
START San Antonio Texas
Next Oncology Virginia Fairfax Virginia
Southside Cancer Care Centre Sydney New South Wales
Peninsula & South Eastern Haematology and Oncology Group Frankston Victoria
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre Heidelberg Victoria
South West Health Care Warrnambool Victoria
NH Hospital a.s. Hořovice Czechia
Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove Hradec Králové Czechia
Onkologicka klinika, Fakultni Nemocnice Olomouc Olomouc Czechia
ICO Angers France
CHU Bordeaux Hospital Saint-Andre Bordeaux France
Centre Jean Perrin Clermont-Ferrand France
Centre Oscar Lambret Lille France
Centre Léon Bérard Lyon France
CHU Nantes Nantes France
ICANS Strasbourg France
S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center Milan Italy
Istituto Europeo Oncologico Milan Italy
Istituto Nazionale Tumori Fondazione G. Pascale Naples Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Centro Ricerche Cliniche di Verona s.r.l. Verona Italy
University Malaya Medical Centre Kuala Lumpur Malaysia
Sarawak General Hospital Kuching Malaysia
Instytut MSF Sp zoo Lodz Poland
Med - Polonia Sp. z o. o. Poznan Poland
Narodowy Instytut Onkologii Warsaw Poland

+ 24 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05462717 on ClinicalTrials.gov ↗ ← All trials in the USA