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
Revolution Medicines, Inc.
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.
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 d…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS. * Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration). * Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \& B for Part 2 Dose Expansion). * Solid tumor or CRC previously treated with no m…
Interventions
- DrugDaraxonrasib
oral tablets
- DrugElironrasib
oral tablets
- DrugZoldonrasib
oral tablets
- DrugIvonescimab
IV infusion
- DrugCarboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)
IV infusion
- Drugcetuximab (Cohort C2 Only)
IV infusion
- DrugCarboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)
IV infusion
Locations (5)
- Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut
- Tennessee OncologyNashville, Tennessee
- NEXT DallasIrving, Texas
- NEXT OncologySan Antonio, Texas
- NEXT VirginiaFairfax, Virginia