NCT06128551

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

Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 534 (estimated)
• Sponsor: Revolution Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Elironrasib	oral tablets
DRUG	Daraxonrasib	oral tablets

Timeline

• Start date: 2023-11-14
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2023-11-13
• Last updated: 2026-02-10

Locations

53 sites across 7 countries: United States, France, Germany, Italy, Netherlands, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study