RightFit
RecruitingPhase 1 / Phase 2

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

A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal 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 new drugs called RAS(ON) inhibitors with standard cancer treatments or other new drugs. It looks at safety, how the body handles the drugs, and whether they may fight cancer. It is for adults with certain cancers of the pancreas or colon and rectum.

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol G: RMC-9805 + cetuximab + FOLFIRI

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 daily activities with little or no limits.
  • Your organs work well enough to meet the study rules.
  • For study groups A, B, C, and G: tests confirm pancreatic cancer that has spread, or colorectal cancer with a RAS gene change that has spread or cannot be removed by surgery.
  • For study groups D, E, F, and G: your cancer has a gene change called RAS G12D.
  • Other study rules may apply.

Who can't join

  • You have a tumor that started in the brain or spinal cord.
  • You have digestive problems that could greatly affect how your body takes in the study drugs.
  • You had major surgery within 28 days before your first dose.
  • Other study rules may apply.

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 * Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, C and G) * Presence of RAS G12D mutation (Subprotocol D, E, F, G) 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 within 28 days of first dose Other inclusion/exclusion criteria may apply.

Study sites (32)

AZ

CA

CO

CT

FL

KS

MA

MD

MN

NC

NE

NJ

NY

OH

OK

PA

TN

TX

UT

VA

WA