A Phase 1/2 interventional study of Elironrasib and Daraxonrasib in Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by Revolution Medicines, Inc.. Recruiting at 56 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Revolution Medicines, Inc. · Phase 1/2, Interventional, and Treatment
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.
This is an open-label, multicenter, Phase 1b/2 study evaluating elironrasib and daraxonrasib, administered as monotherapy and in combination, in patients with advanced KRAS G12C-mutated solid tumors to determine the maximum tolerated dose (MTD), identify the recommended Phase 2 dose and schedule (RP2DS), and preliminarily assess antitumor activity.
The study includes a Phase 1b dose escalation and expansion of combination therapy, followed by a Phase 2 evaluation of the selected RP2DS as monotherapy and combination therapy to further assess safety and antitumor activity.
Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
Exclusion Criteria:
Phase 2 only
Drug: Elironrasib
Phase 2 only
Drug: Daraxonrasib
Phase 1b and 2
Drug: Elironrasib · Drug: Daraxonrasib
oral tablets
Also known as: RMC-6291
oral tablets
Also known as: RMC-6236
Number of patients with adverse events (AEs) in Phase 1b
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: Up to approximately 3 years
Changes in vital signs in Phase 1b
Number of patients with clinically significant changes in vital signs
Time frame: Up to approximately 3 years
Changes in clinical laboratory test values in Phase 1b
Number of patients with clinically significant changes in clinical laboratory test values
Time frame: Up to approximately 3 years
Dose Limiting Toxicities in Phase 1b
Number of participants with dose limiting toxicities
Time frame: 21 days
Changes in ECGs in Phase 1b
Number of patients with clinically significant changes in ECGs
Time frame: Up to approximately 3 years
Overall Response Rate (ORR) in Phase 2
Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)
Time frame: Up to approximately 3 years
Maximum Observed Blood Concentration of Elironrasib and Daraxonrasib
Cmax
Time frame: up to 21 weeks
Time to Reach Maximum Blood Concentration of Elironrasib and Daraxonrasib
Tmax
Time frame: up to 21 weeks
Area Under Blood Concentration Time Curve of Elironrasib and Daraxonrasib
AUC
Time frame: up to 21 weeks
Elimination Half-Life of Elironrasib and Daraxonrasib
t1/2
Time frame: up to 21 weeks
Ratio of accumulation of Elironrasib and Daraxonrasib from a single dose to steady state with repeated dosing
accumulation ratio
Time frame: up to 21 weeks
Overall Response Rate (ORR) in Phase 1b
Overall response rate per RECIST v1.1
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Duration of response per RECIST v1.1
Time frame: Up to approximately 3 years
Disease Control Rate in Phase 1b
Disease Control rate per RECIST v1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) in Phase 1b
Time to response per RECIST v1.1
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS)
Progression-free survival per RECIST v1.1
Time frame: Up to approximately 3 years
Number of patients with AEs in Phase 2
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5
Time frame: Up to approximately 3 years
Changes in vital signs in Phase 2
Number of patients with clinically significant changes in vital signs
Time frame: Up to approximately 3 years
Changes in clinical laboratory values in Phase 2
Number of patients with clinically significant changes in clinical laboratory test values
Time frame: Up to approximately 3 years
Overall Survival (OS) in Phase 2
OS is defined as time from enrollment until death from any cause
Time frame: Up to approximately 3 years
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
Revolution Medicines, Inc.