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

NCT07612930 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-05-29

No results posted yet for this study

Summary

This expanded access program provides a potential pathway for eligible patients with resected pancreatic ductal adenocarcinoma (PDAC) to receive PCNAT-01, an investigational, personalized tumor neoantigen peptide vaccine, outside of the ongoing clinical trial when participation in the clinical trial is not possible or feasible. PCNAT-01 is intended for use in disease-free patients following surgical resection and completion of standard adjuvant therapy to reduce the risk of recurrence. Access is subject to Sponsor review, regulatory authorization, institutional review board approval, physician oversight, successful patient-specific vaccine manufacture, and confirmation that treatment under expanded access will not interfere with the ongoing clinical development program.

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

BIOLOGICAL

PCNAT-01

PCNAT-01 is an investigational, personalized tumor neoantigen peptide vaccine composed of patient-specific synthetic peptides and Poly-ICLC. Each dose contains 7 to 25 linear neoantigen peptides, 0.3mg/peptide/vial, assigned into 4 predefined peptide pools. PCNAT-01 is administered by subcutaneous injection after surgical resection and completion of standard adjuvant therapy on Days 1, 4, 8, 15, and 22, followed by booster doses at Weeks 12 and 20, for up to 7 total doses. At each visit, the 4 peptide pools are administered as separate subcutaneous injections to fixed anatomical areas: right upper arm, left upper arm, right thigh, and left thigh. For each subject, the peptide pool assigned to each injection area remains consistent across all doses.

Sponsors & Collaborators

  • Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07612930 on ClinicalTrials.gov