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Recruiting NCT07349537

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

Phase I Interventional Non-small Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC) Pancreatic Adenocarcinoma Pancreatic Ductal Adenocarcinoma (PDAC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RMC-5127, daraxonrasib, cetuximab.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Overview

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.

Detailed description

This is an open-label, multicenter, Phase 1/1b study of RMC-5127 in adults with advanced KRAS G12V-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of three arms: RMC-5127 monotherapy arm, RMC-5127 plus daraxonrasib combination arm, and RMC-5127 plus cetuximab combination arm. All arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion. Both parts of the monotherapy arm may include Food Effect Cohorts.

Interventions

  • Drug RMC-5127
    oral tablets
  • Drug daraxonrasib
    oral tablets
  • Drug cetuximab
    IV infusion

Primary outcome measures

  • Number of patients with adverse events (AEs) [Time frame: Up to approximately 3 years]
  • Changes in vital signs [Time frame: Up to approximately 3 years]
  • Changes in electrocardiogram (ECG) test values [Time frame: Up to approximately 3 years]
  • Changes in clinical laboratory test values [Time frame: Up to approximately 3 years]
  • Dose Limiting Toxicities [Time frame: Up to 28 days]
Secondary outcome measures (7)
  • Cmax concentrations of RMC-5127 and daraxonrasib [Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days)]
  • Tmax concentration of RMC-5127 and daraxonrasib [Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days)]
  • AUC concentrations of RMC-5127 and daraxonrasib [Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days)]
  • Ratio of accumulation of RMC-5127 [Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days)]
  • Half-Life of RMC-5127 and daraxonrasib [Time frame: Up to Cycle 5 Day 1 (each cycle is up to 28 days)]
  • Objective Response Rate (ORR) [Time frame: Up to approximately 3 years]
  • Duration of Response (DOR) [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • 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.
  • Measurable per RECIST v1.1
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

Exclusion criteria

  • 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).
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Yale Cancer Center — New Haven
  • Johns Hopkins — Baltimore
  • Dana-Farber Cancer Institute — Boston
  • START Midwest — Grand Rapids
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health — New York
  • NEXT - Dallas — Dallas
  • NEXT — San Antonio
  • START - San Antonio — San Antonio
  • … and 1 more center

Identifiers

NCT: NCT07349537 · RMC-5127-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗