Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Investigational Medication for Metastatic Pancreatic Cancer

Recruiting
18 years or above
All
Phase 3
460 participants needed
15 Locations

Study Overview

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

Study Details

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen.

Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Cancer, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically or cytologically confirmed PDAC with metastatic disease.
  • Measurable disease per RECIST 1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation)
  • Documented RAS mutation status, either mutant or wild-type. Eligible RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  • Able to take oral medications.

Exclusion Criteria:

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • History of or known central nervous system metastatic disease.
  • Any conditions that may affect the ability to take or absorb study treatment
  • Major surgery within 4 weeks prior to randomization.
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures

Updated on 03 Feb 2025. Study ID: NCT06625320

This study investigates the safety and effectiveness of an investigational medication compared to standard chemotherapy treatments. The focus is on patients with metastatic pancreatic ductal adenocarcinoma (PDAC), a type of cancer that has spread from the pancreas to other parts of the body. The study will compare two approaches: the investigational medication and the standard chemotherapy chosen by the investigator.

Participants in the study will be randomly assigned to one of two study arms. In Arm A, they will receive the investigational medication, while in Arm B, they will receive a standard chemotherapy treatment. The goal is to see if the investigational medication can improve the time patients live without the cancer getting worse or improve overall survival compared to standard treatments.

  • Who can participate: Adults aged 18 or older with metastatic pancreatic cancer can participate if they have RAS mutations and have not previously received RAS-targeted therapy. They must have good organ function and be able to take oral medications.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or standard chemotherapy. There is no placebo involved in this study. The investigational medication is being tested to see if it is more effective than the usual treatments for this type of cancer.

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