Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
a study on Solid Tumor Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer Colorectal Tumor
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCSF
- Dates
- study startedstudy ends around
Description
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.
Official Title
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
Details
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.
Keywords
Advanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC, Colorectal Cancer (CRC), CRC, Non-small Cell Lung Cancer, Colorectal Cancer, RAS, NRAS, KRAS, HRAS, RAS Mutation, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Carboplatin, Cisplatin, Pemetrexed, Cetuximab, Daraxonrasib, Elironrasib, Zoldonrasib, Ivonescimab, Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only), cetuximab (Cohort C2 Only), Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only), Daraxonrasib (Cohort B1 only)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).
- Measurable disease per RECIST v1.1
- Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).
- Able to take oral medications.
You CAN'T join if...
- Head and neck squamous cell carcinoma.
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery within 4 weeks prior to receiving study drug(s).
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
- Other inclusion/exclusion criteria may apply.
Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
accepting new patients
San Francisco California 94158 United States - USC Norris Comprehensive Cancer Center
accepting new patients
Los Angeles California 90033 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Revolution Medicines, Inc.
- ID
- NCT07397338
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 370 study participants
- Last Updated
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study, which might include an external sponsor. Providing your contact details does not obligate you to participate in the research.
Thank you!
The study team should get back to you in a few business days.