Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only): IV infusion
cetuximab (Cohort C2 Only): IV infusion
Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only): IV infusion
Daraxonrasib (Cohort B1 only): oral tablets
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Number of patients with adverse events (AEs) — Up to approximately 4 years Number of patients with AEs as assessed by CTCAE v5.
Changes in vital signs — Up to approximately 4 years Number of patients with changes in vital signs.
Changes in clinical laboratory test values — Up to approximately 4 years Number of patients with changes in clinical laboratory test values.
Dose Limiting Toxicities — 28 days Number of patients with dose limiting toxicities
Trial sites (9)
Facility
City
Region
Status
USC Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
Eastern Connecticut Hematology and Oncology Associates
Norwich
Connecticut
Recruiting
Health Partners Cancer Center at Regions Hospital
Saint Paul
Minnesota
Recruiting
Tennessee Oncology
Nashville
Tennessee
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
NEXT Dallas
Irving
Texas
Recruiting
NEXT Oncology
San Antonio
Texas
Recruiting
NEXT Virginia
Fairfax
Virginia
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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