Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib

This EAP has been established to provide access to daraxonrasib to patients with previously treated metastatic pancreatic adenocarcinoma during the period before potential commercial availability. Patients may be eligible if they have progressed on, are intolerant of, or are no longer expected to benefit from available standard therapies, and if they are not able to enroll in a clinical trial of daraxonrasib due to ineligibility or lack of access. This EAP is intended to address an unmet medical need and is not designed to support clinical development objectives.

Daraxonrasib is an investigational, orally administered, RAS(ON) inhibitor administered as monotherapy. Daraxonrasib will be supplied by the Sponsor free of charge during the duration of treatment under this program.

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.
• 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

Exclusion Criteria:

• 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.