About this trial

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 criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Daraxonrasib
  • Elironrasib
  • Zoldonrasib
  • Ivonescimab
  • Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)
  • cetuximab (Cohort C2 Only)
  • Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)
  • Daraxonrasib (Cohort B1 only)

Treatment groups

370 Participants
are divided into 3 treatment groups

Locations

6
Eastern Connecticut Hematology and Oncology Associates06360, NorwichConnecticut, United States
Tennessee Oncology37023, NashvilleTennessee, United States
MD Anderson Cancer Center77030, HoustonTexas, United States
NEXT Dallas75039, IrvingTexas, United States

Sponsors and collaborators

Revolution Medicines, Inc.

Lead sponsor

Summit Therapeutics

Collaborator