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 Germany 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

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)

Facility	City	Region	Status
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 Germany

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) Recruiting

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC Recruiting

Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Active, not recruiting

Other trials for the same condition

Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs Recruiting

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) Active, not recruiting

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours Recruiting

A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer Recruiting

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant 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 Germany