Expanded Access to PCNAT-01 for Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Adjuvant Therapy

PCNAT-01 is an investigational, personalized tumor neoantigen peptide vaccine composed of patient-specific synthetic peptides and Poly-ICLC. PCNAT-01 is being evaluated in Study PCNAT-01-2024-104, a Phase 1, multicenter, open-label study in disease-free patients with resected PDAC after completion of standard adjuvant chemotherapy. The ongoing Phase 1 study evaluates the safety, tolerability, immunogenicity, and preliminary clinical activity of PCNAT-01 and includes a Phase 1a dose-escalation part followed by a Phase 1b dose-expansion part. This expanded access program is related to Study PCNAT-01-2024-104, "A Phase 1, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of PCNAT-01 in Patients With Pancreatic Cancer Following Surgical Resection and Adjuvant Therapy" \[NCT number to be added once assigned\]. Whenever feasible, participation in the clinical trial should be considered before expanded access. This expanded access program is intended for eligible patients who may have a serious disease history of resected PDAC and are at risk of recurrence after standard therapy but are unable to participate in the ongoing PCNAT-01 clinical trial. Whenever feasible, participation in the clinical trial should be considered before expanded access. Expanded access may be considered only when the requesting physician determines that the patient has no comparable or satisfactory alternative options and that the potential benefit justifies the potential risks. Because PCNAT-01 is personalized, access depends on the availability of adequate tumor tissue, successful sequencing and neoantigen identification, and successful manufacture and release of the individualized vaccine. Patients must also meet protocol-defined clinical, safety, laboratory, disease-status, and tumor-marker requirements before receiving PCNAT-01. Requests will be reviewed on a case-by-case basis by the Sponsor in collaboration with the treating physician. Treatment may proceed only after all applicable regulatory, institutional, informed consent, and product-release requirements are satisfied.