Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Start Date
1/30/2026
Completion Date
5/1/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Daraxonrasib
Elironrasib
Zoldonrasib
Ivonescimab
Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)
cetuximab (Cohort C2 Only)
Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)
Daraxonrasib (Cohort B1 only)
Conditions
Locations
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut 06360
United States
Tennessee Oncology
Nashville, Tennessee 37023
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Dallas
Irving, Texas 75039
United States
NEXT Oncology
San Antonio, Texas 78229
United States
NEXT Virginia
Fairfax, Virginia 22031
United States