Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma

Open to people ages 18 years and up

• 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.
• Evidence of active disease progression during or following the most recent line of systemic therapy for PDAC, based on investigator assessment.
• At least one prior line of systemic therapy in the metastatic setting, which must include either a fluoropyrimidine-based or gemcitabine-based regimen.
• Received and progressed, been intolerant to prior standard therapy, or no longer expected to benefit from standard therapies.
• Adequate bone marrow, renal, hepatic, and coagulation functions.
• Ineligible for, or unable to enroll in, another clinical trial of daraxonrasib, if available.
• Able to take oral medications

• History of known central nervous system metastatic disease.
• Concurrent systemic anticancer therapy.
• Significant cardiovascular disease.
• Major GI conditions that may affect the ability to take or absorb daraxonrasib (patients with prior Whipple procedure are eligible).
• Active uncontrolled systemic infection.
• Major surgery within 28 days before enrollment.
• Additional inclusion and exclusion criteria may apply.