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

ConditionsAdvanced Solid TumorsMetastatic Solid TumorsNon-small Cell Lung Cancer (NSCLC)NSCLCColorectal Cancer (CRC)CRC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Daraxonrasib

    Drug

    oral tablets

  • Elironrasib

    Drug

    oral tablets

  • Zoldonrasib

    Drug

    oral tablets

  • Ivonescimab

    Drug

    IV infusion

  • Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)

    Drug

    IV infusion

  • cetuximab (Cohort C2 Only)

    Drug

    IV infusion

  • Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)

    Drug

    IV infusion

  • Daraxonrasib (Cohort B1 only)

    Drug

    oral tablets

Treatment groups

370 Participants
are divided into 3 treatment groups
Group A: Arm A: Daraxonrasib + Ivonescimab CombinationExperimental treatment 3 interventions
Group B: Arm B: Elironrasib + Ivonescimab CombinationExperimental treatment 4 interventions
Group C: Arm C: Zoldonrasib + Ivonescimab CombinationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of patients with adverse events (AEs)

Number of patients with AEs as assessed by CTCAE v5.

Time frame
Up to approximately 4 years
2

Changes in vital signs

Number of patients with changes in vital signs.

Time frame
Up to approximately 4 years
3

Changes in clinical laboratory test values

Number of patients with changes in clinical laboratory test values.

Time frame
Up to approximately 4 years
4

Dose Limiting Toxicities

Number of patients with dose limiting toxicities

Time frame
28 days

Secondary outcomes

1

Concentration of RAS(ON) inhibitors and ivonescimab

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

Time frame
Up to Cycle 6 Day 1 (each cycle is 21 days)
2

Objective Response Rate (ORR)

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

Time frame
Up to approximately 4 years
3

Duration of Response (DOR)

DOR per RECIST v1.1

Time frame
Up to approximately 4 years
4

Disease Control Rate (DCR)

DCR per RECIST v1.1

Time frame
Up to approximately 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Revolution Medicines, Inc.

Lead sponsor

Summit Therapeutics

Collaborator

Source ClinicalTrials.gov
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