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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 252
- Locations
- 76
- Primary Endpoint
- • Incidence of DLTs (Part 1 and Part 2 safety lead-ins only)
Study Overview
Brief Summary
• To evaluate the safety and tolerability of RAS(ON) inhibitors in combination with ivonescimab in patients with advanced RAS-mutated solid tumors • To define the RP2D for RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, in patients with advanced RAS-mutated solid tumors
Study Design
- Allocation
- Na
- Primary Purpose
- A Research Study Testing New Cancer Medicines Used Alone Or Together To Treat Solid Tumors
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants may be included in the study if they • are at least 18 years old. • have a RAS-mutated cancer that has spread or cannot be removed by surgery and at least one tumor that can be measured by scans. Some parts of the study are only open to participants with a specific RAS mutation type. • have adequate organ function.
Exclusion Criteria
- •Participants cannot be included in the study if they • have previously received certain medicines that directly target RAS, or certain immune or anti-VEGF therapies (cancer treatment that stops tumors from growing new blood vessels). • have any medical condition including a bleeding issue, or active infections that may interfere with the study medicine. • are pregnant or breastfeeding. • depending on the part of the study, participants may or may not have received previous treatment for their cancer.
Arms & Interventions
Pemetrexed 25 mg/ml concentrate for solution for infusion
Intervention: Pemetrexed 25 mg/ml concentrate for solution for infusion (Drug)
Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Intervention: Carboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
DARAXONRASIB (RMC-6236), DARAXONRASIB (RMC-6236)
Intervention: DARAXONRASIB (RMC-6236) (Drug)
ivonescimab
Intervention: ivonescimab (Drug)
RMC-9805
Intervention: RMC-9805 (Drug)
RMC-6291, RMC-6291
Intervention: RMC-6291 (Drug)
Erbitux 5 mg/mL solution for infusion
Intervention: Erbitux 5 mg/mL solution for infusion (Drug)
Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Intervention: Cisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung (Drug)
Outcomes
Primary Outcomes
• Incidence of DLTs (Part 1 and Part 2 safety lead-ins only)
• Incidence of DLTs (Part 1 and Part 2 safety lead-ins only)
• Incidence of AEs, TRAEs, SAEs, and clinically significant changes in laboratory test values and vital signs
• Incidence of AEs, TRAEs, SAEs, and clinically significant changes in laboratory test values and vital signs
Secondary Outcomes
- • DCR, TTR and PFS per RECIST v1.1
- • RAS(ON) inhibitor concentrations over time as applicable
- • ORR and DOR per RECIST v1.1
- • Ivonescimab serum concentrations over time as applicable
- • Number and percentage of patients with detectable anti-ivonescimab antibody (ADA) at baseline and post treatment
Investigators
Marie Keegan
Scientific
Revolution Medicines Inc.