Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors

NCT07397338
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Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
370
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Lead sponsor
Revolution Medicines, Inc.
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Start date
2026-01-30
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Number of sites
9
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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.
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Short title
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2029-05-01
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First posted
2026-02-09
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Registry last updated
2026-08-03
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Primary completion date
2029-05-01
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Start date
2026-01-30
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Participants
370
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Participant count basis
Estimated
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Planned participants
370
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Protocol amendments
0
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Number of sites
9
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Revolution Medicines, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07397338
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ClinicalTrials.gov ID
NCT07397338
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of patients with adverse events (AEs)

    Timeframe: Up to approximately 4 years

    Number of patients with AEs as assessed by CTCAE v5.

  2. Changes in vital signs

    Timeframe: Up to approximately 4 years

    Number of patients with changes in vital signs.

  3. Changes in clinical laboratory test values

    Timeframe: Up to approximately 4 years

    Number of patients with changes in clinical laboratory test values.

  4. Dose Limiting Toxicities

    Timeframe: 28 days

    Number of patients with dose limiting toxicities

  1. Concentration of RAS(ON) inhibitors and ivonescimab

    Timeframe: Up to Cycle 6 Day 1 (each cycle is 21 days)

    Trough and peak blood concentrations of RAS(ON) inhibitors and ivonescimab over time as applicable.

  2. Objective Response Rate (ORR)

    Timeframe: Up to approximately 4 years

    ORR per response evaluation criteria in solid tumors (RECIST) v1.1

  3. Duration of Response (DOR)

    Timeframe: Up to approximately 4 years

    DOR per RECIST v1.1

  4. Disease Control Rate (DCR)

    Timeframe: Up to approximately 4 years

    DCR per RECIST v1.1

  5. Time to response (TTR)

    Timeframe: Up to approximately 4 years

    TTR per RECIST v1.1

  6. Progression free survival (PFS)

    Timeframe: Up to approximately 4 years

    PFS per RECIST v1.1

  7. Anti-drug Antibody (ADA) of ivonescimab

    Timeframe: Up to approximately 4 years

    Number and percentage of patients with anti-ivonescimab antibody

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
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  • USC Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • Eastern Connecticut Hematology and Oncology AssociatesNorwich, United StatesRecruiting
  • Health Partners Cancer Center at Regions HospitalSaint Paul, United StatesRecruiting
  • Tennessee OncologyNashville, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • NEXT DallasIrving, United StatesRecruiting
  • NEXT OncologySan Antonio, United StatesRecruiting
  • NEXT VirginiaFairfax, United StatesRecruiting
Sources for sites
clinicaltrials.gov

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