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RecruitingPhase 1 / Phase 2

Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

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 new RAS(ON) drugs alone, with standard cancer treatments, or with each other. It checks safety, side effects, how the body handles the drugs, and early signs that they fight cancer. It is for adults with advanced cancer with certain RAS gene changes, mainly non-small cell lung cancer (NSCLC).

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

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 18 or older.
  • You can do all or most daily activities, but may need to avoid hard physical activity.
  • Your organs work well enough to meet the study rules.
  • You have had standard treatment suited to your cancer type and stage.
  • Group A: Tests confirm a solid tumor with a KRAS G12C gene change. It has grown into nearby areas or spread farther, and surgery cannot cure it.
  • Group B: Tests confirm NSCLC with a RAS gene change. It has grown into nearby areas or spread farther.
  • Groups C and D: Tests confirm NSCLC with a RAS G12D gene change. It has grown into nearby areas or spread farther.

Who can't join

  • You have a tumor that started in the brain or spinal cord.
  • You have digestive problems that could greatly change how your body absorbs the study drugs.
  • You had major surgery less than 28 days before your first study dose.
  • You have or have had interstitial lung disease or pneumonitis—lung conditions that cause scarring or swelling—that required steroids.

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

Official eligibility criteria

Inclusion criteria: All Patients (unless otherwise noted): * ≥ 18 years of age * ECOG PS is 0 to 1 * Adequate organ function as outlined by the study * Received prior standard therapy appropriate for tumor type and stage * Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A) * Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B) * Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D) Exclusion criteria: All Patients: * Primary central nervous system (CNS) tumors * Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs * Major surgery \< 28 days of first dose * Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids Other inclusion/exclusion criteria may apply.

Study sites (29)

AZ

CA

DC

FL

MA

MI

MT

NE

NY

OH

PA

TN

TX

VA

WA