NCT07397338

Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: Revolution Medicines, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.

Detailed description

This is an open-label, multicenter, Phase 1/2 study of RAS(ON) inhibitors in combination with ivonescimab with or without other anti-cancer agents in adults with advanced or metastatic solid tumors with a RAS mutation to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of three arms: Arm A:daraxonrasib in combination with ivonescimab; Arm B: elironrasib in combination with ivonescimab; and Arm C: zoldonrasib in combination with ivonescimab. All arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion. Part 1 dose exploration will explore the safety and tolerability of individual RAS(ON) inhibitors in combination with ivonescimab. Part 2 dose expansion will explore the safety, tolerability, and antitumor activity of the individual RAS(ON) inhibitors with ivonescimab +/- anti-cancer therapies.

Conditions

• Advanced Solid Tumors
• Metastatic Solid Tumors
• Non-small Cell Lung Cancer (NSCLC)
• NSCLC
• Colorectal Cancer (CRC)
• CRC

Interventions

Type	Name	Description
DRUG	Daraxonrasib	oral tablets
DRUG	Elironrasib	oral tablets
DRUG	Zoldonrasib	oral tablets
DRUG	Ivonescimab	IV infusion
DRUG	Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)	IV infusion
DRUG	cetuximab (Cohort C2 Only)	IV infusion
DRUG	Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)	IV infusion
DRUG	Daraxonrasib (Cohort B1 only)	oral tablets

Timeline

• Start date: 2026-01-30
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2026-02-09
• Last updated: 2026-03-30

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study