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Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

ConditionsNon-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic AdenocarcinomaPancreatic Ductal Adenocarcinoma (PDAC)PDACCRCNSCLCPancreatic CancerLung Cancer (NSCLC)Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
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 RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

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.

Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.

Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.

Disqualifiers

Primary central nervous system (CNS) tumors

Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).

Any conditions that may affect the ability to take or absorb study drug.

Major surgery within 28 days prior to receiving study drug(s).

Trial design

Design model

Parallel

Treatments tested in this trial

  • RMC-5127

    Drug

    oral tablets

  • daraxonrasib

    Drug

    oral tablets

  • cetuximab

    Drug

    IV infusion

Treatment groups

574 Participants
are divided into 3 treatment groups
Group A: Arm A: RMC-5127 MonotherapyExperimental treatment 1 intervention
Group B: Arm B: RMC-5127 + Daraxonrasib CombinationExperimental treatment 2 interventions
Group C: Arm C: RMC-5127 + Cetuximab CombinationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of patients with adverse events (AEs)

Number of patients with AEs as assessed by Common Terminology Criteria for Adverse Events CTCAE v5

Time frame
Up to approximately 3 years
2

Changes in vital signs

Number of patients with changes from baseline in vital signs

Time frame
Up to approximately 3 years
3

Changes in electrocardiogram (ECG) test values

Number of patients with changes from baseline in ECG test values

Time frame
Up to approximately 3 years
4

Changes in clinical laboratory test values

Number of patients with changes from baseline in clinical laboratory test values

Time frame
Up to approximately 3 years

Secondary outcomes

1

Cmax concentrations of RMC-5127 and daraxonrasib

Maximum blood concentration (Cmax) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and Cmax of daraxonrasib in combination with RMC-5127 over time as applicable

Time frame
Up to Cycle 5 Day 1 (each cycle is up to 28 days)
2

Tmax concentration of RMC-5127 and daraxonrasib

Time to reach maximum blood concentration (Tmax) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and Tmax of daraxonrasib in combination with RMC-5127 over time as applicable

Time frame
Up to Cycle 5 Day 1 (each cycle is up to 28 days)
3

AUC concentrations of RMC-5127 and daraxonrasib

Area under the blood concentration time curve (AUC) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and AUC of daraxonrasib in combination with RMC-5127 over time as applicable

Time frame
Up to Cycle 5 Day 1 (each cycle is up to 28 days)
4

Ratio of accumulation of RMC-5127

Ratio of accumulation of RMC-5127 from a single dose to steady state with repeated dosing as monotherapy and in combination with darabxrasib or cetuximab over time as applicable

Time frame
Up to Cycle 5 Day 1 (each cycle is up to 28 days)

Other outcomes

Sponsors and contacts

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

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
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