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

Trial ID: NCT06128551

Interventional - Phase 1/2 - Recruiting

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.

Conditions

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

Interventions

• Elironrasib
• Daraxonrasib

Eligibility

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

Sponsor

Revolution Medicines, Inc.

Source: ClinicalTrials.gov

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