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

NCT07612930 | Unknown

• 1 other identifier: PCNAT-01-2026-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Pancreatic Ductal Adenocarcinoma; PDAC; Personalized Neoantigen Vaccine; Peptide Vaccine; Tumor Neoantigen; Cancer Vaccine; Recurrence Prevention; Recurrence-Free Survival; Adjuvant Therapy

Interventions

PCNAT-01 BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older.
• Histologically confirmed pancreatic ductal adenocarcinoma.
• Prior R0 or R1 surgical resection of PDAC.
• Completion of standard adjuvant therapy, unless discontinued early due to intolerable toxicity as permitted after Sponsor and physician review.
• No evidence of disease recurrence before PCNAT-01 administration.
• ECOG performance status of 0 or 1, or otherwise acceptable functional status based on treating physician and Sponsor assessment.
• Adequate organ and marrow function to receive PCNAT-01.
• Availability of adequate tumor tissue for sequencing and neoantigen identification.
• Successful identification of sufficient patient-specific neoantigens for PCNAT-01 manufacture.
• Ability to provide informed consent and comply with expanded access procedures.
• For patients of reproductive potential, willingness to comply with pregnancy testing and contraception requirements.

You may not qualify if:

• Ability to participate in the ongoing PCNAT-01 clinical trial, if trial participation is feasible and appropriate.
• Evidence of recurrent, metastatic, or unresectable disease before planned PCNAT-01 administration, unless specifically accepted after Sponsor and physician review.
• Known hypersensitivity or intolerance to PCNAT-01, Poly-ICLC, or any component of the vaccine.
• Active uncontrolled infection or clinically significant viral infection.
• Active or suspected autoimmune disease requiring systemic treatment, except protocol-permitted conditions.
• Immunodeficiency disease, organ transplantation requiring immunosuppression, or chronic systemic immunosuppressive therapy.
• Clinically significant cardiovascular disease, uncontrolled hypertension, clinically significant arrhythmia, or other uncontrolled medical condition.
• Recent live or live-attenuated vaccination, recent prohibited anticancer therapy, or recent major surgery within a timeframe considered unsafe by the treating physician and Sponsor.
• Unresolved clinically significant toxicity from prior anticancer therapy.
• Pregnancy or breastfeeding.
• Any condition that, in the opinion of the treating physician or Sponsor, would make expanded access treatment unsafe, interfere with patient monitoring, or compromise the ongoing clinical development program.

Sponsors & Collaborators

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

Central Study Contacts

H. Chen, MD

CONTACT

+86 021-54920606; hmchen@andabiopharma.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05