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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests RMC-5127 alone or with either daraxonrasib or cetuximab in adults with advanced solid tumors that have a KRAS G12V gene change. It looks at safety, how well people tolerate treatment, how the body handles the drug, and early signs that it works against cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 and have agreed to join after learning about the study.
  • You can do all usual activities or have limits only with hard physical activity.
  • Tests confirm a solid tumor with a KRAS G12V gene change that has grown into nearby tissue or spread to other parts of the body.
  • Your cancer got worse after standard treatment for your cancer type and stage, or you could not tolerate that treatment.
  • Your cancer can be measured using the study’s rules.
  • Your bone marrow, liver, kidneys, and blood clotting work well enough for the study.
  • You can take medicine by mouth.

Who can't join

  • You have a tumor that started in the brain or spinal cord.
  • You previously had a KRAS G12V blocker or another treatment that directly targets RAS, such as a drug that blocks or breaks down RAS.
  • You have a condition that could affect your ability to take or absorb the study drug.
  • You had major surgery within 28 days before starting the study drugs.
  • You cannot or do not want to follow the required study visits or procedures.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (9)

CT

MA

MD

MI

NY

TX

VA