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Clinical Trials in the USA / NCT06128551
Recruiting Phase 1/2

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors

NCT06128551 · tracked via the Priya Life Science USA tracker
Sponsor
Revolution Medicines, Inc
Phase
Phase 1/2
Started
2023-11-14
Last updated
2026-09-22

Condition(s) studied

Non-Small Cell Lung Cancer (NSCLC)Colorectal CancerPancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

Elironrasib →Daraxonrasib →

Elironrasib: oral tablets

Daraxonrasib: oral tablets

Study summary

This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 18 years of age * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. Phase 1b Dose Escalation: solid tumors, previously treated 2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors. * ECOG performance status 0 or 1 * 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

Primary outcome measure(s)

  • Number of patients with adverse events (AEs) in Phase 1b — Up to approximately 3 years
    Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
  • Changes in vital signs in Phase 1b — Up to approximately 3 years
    Number of patients with clinically significant changes in vital signs
  • Changes in clinical laboratory test values in Phase 1b — Up to approximately 3 years
    Number of patients with clinically significant changes in clinical laboratory test values
  • Dose Limiting Toxicities in Phase 1b — 21 days
    Number of participants with dose limiting toxicities
  • Changes in ECGs in Phase 1b — Up to approximately 3 years
    Number of patients with clinically significant changes in ECGs
  • Overall Response Rate (ORR) in Phase 2 — Up to approximately 3 years
    Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)

Trial sites (56)

FacilityCityRegionStatus
City of Hope Duarte California Withdrawn
UC IRVINE Health Orange California Recruiting
UC Davis Comprehensive Cancer Center Sacramento California Recruiting
Stanford Cancer Institute Stanford California Recruiting
University of Colorado Cancer Center Aurora Colorado Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
Moffitt Cancer Center and Research Institute Tampa Florida Recruiting
Community Health Network Indianapolis Indiana Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Cancer Detroit Michigan Withdrawn
START Midwest Grand Rapids Michigan Recruiting
Columbia University New York New York Recruiting
NYU Langone Health New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
University of Oklahoma Oklahoma City Oklahoma Recruiting
Allegheny Health Network Pittsburgh Pennsylvania Recruiting
Sarah Cannon Research Institue Nashville Tennessee Recruiting
Mary Crowley Cancer Research Dallas Texas Completed
MD Anderson Houston Texas Recruiting
NEXT Dallas Irving Texas Recruiting
NEXT Oncology San Antonio San Antonio Texas Recruiting
START Texas San Antonio Texas Recruiting
NEXT Oncology Virginia Fairfax Virginia Recruiting
West Cancer Institute Angers France Recruiting
Institut Bergonie Bordeaux France Recruiting
Hospital Louise Pradel Bron France Recruiting
Oscar Lambret Center of Lillle Lille France Recruiting
Centre Leon Berard Lyon France Recruiting
Cancer Institute of Montpellier Montpellier France Recruiting
CHU Nantes Nantes France Recruiting
Institute of Cancer of Strasbourg Strasbourg France Withdrawn
Universitäts Klinikum Köln Cologne Germany Recruiting
Klinikum Esslingen GmbH Esslingen am Neckar Germany Recruiting
Krankenhaus Bethanien Moers Moers Germany Recruiting
Klinkum Nurnberg Paracelsus Medical Unviersity Nuremberg Germany Recruiting
Centro Ricerche Cliniche di Verona Srl Verona Veneto Recruiting
Department of Medical Oncology - Azienda Ospedaliero Uniersitaria delle Marche Ancona Italy Recruiting
Centro Di Riferimento Oncologico Aviano Italy Recruiting
Institute Romagnolo per lo Studio Tumori Meldola Italy Recruiting
Niguarda Cancer Center Milan Italy Recruiting

+ 16 more sites — see the full list on the official registry below.

More Revolution Medicines, Inc. trials in the USA

Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors Recruiting
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC Recruiting
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Active, not recruiting
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Recruiting
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) Recruiting

Other trials for the same condition

A Phase 1 Study of IM-1617 in Participants With Advanced Cancer Recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies Recruiting
A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours Active, not recruiting
A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202) Recruiting
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors Active, not recruiting
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 NCT06128551 on ClinicalTrials.gov ↗ ← All trials in the USA