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

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer, Pancreatic Ductal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06128551

Run by

Revolution Medicines, Inc.

People needed

534

Starts

2023-11-14

Expected to finish

2029-06-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age
• Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
• Phase 1b Dose Escalation: solid tumors, previously treated
• 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

You may not qualify if…

• 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

Where it is running

• Oscar Lambret Center of Lillle — Lille, France (enrolling)
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Hospital Louise Pradel — Bron, France (enrolling)
• UC IRVINE Health — Orange, California, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Moffitt Cancer Center and Research Institute — Tampa, Florida, United States (enrolling)
• Community Health Network — Indianapolis, Indiana, United States (enrolling)
• Stanford Cancer Institute — Stanford, California, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• START Midwest — Grand Rapids, Michigan, United States (enrolling)
• Columbia University — New York, New York, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (enrolling)
• Sarah Cannon Research Institue — Nashville, Tennessee, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• MD Anderson — Houston, Texas, United States (enrolling)
• NEXT Dallas — Irving, Texas, United States (enrolling)
• NEXT Oncology San Antonio — San Antonio, Texas, United States (enrolling)
• START Texas — San Antonio, Texas, United States (enrolling)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (enrolling)
• West Cancer Institute — Angers, France (enrolling)
• Institut Bergonie — Bordeaux, France (enrolling)
• Centre Leon Berard — Lyon, France (enrolling)

Full record on ClinicalTrials.gov

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