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

Launched by REVOLUTION MEDICINES, INC. · Oct 1, 2024

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ClinConnect Summary

This clinical trial is studying a new treatment called RMC-6236 for patients with metastatic pancreatic ductal adenocarcinoma (PDAC), which is a type of pancreatic cancer that has spread to other parts of the body. The goal is to see how safe and effective this new treatment is compared to the standard care options currently available. The trial is open to adults aged 18 and older who have been diagnosed with PDAC and have measurable disease. Participants should have a good performance status, meaning they are able to carry out daily activities with little assistance, and they need to have specific mutations in their cancer that the treatment is designed to target.

If you decide to participate in this trial, you will be monitored closely to assess your health and the effects of the treatment. It’s important to know that certain individuals may not be eligible, such as those who have previously received specific RAS-targeted therapies or have certain health conditions that could affect their ability to take the study medication. This is an opportunity to potentially access a new treatment option while contributing to research that may help others with pancreatic cancer in the future.

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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.
• • 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. 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