Access to PCNAT-01 Vaccine for Patients with Removed Pancreatic Cancer After Surgery and Additional Treatment

Sponsor: Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.

Expanded Access
Sponsor score: 0

ClinicalTrials ID:NCT07612930

Provider View

This program offers a way for patients who have had pancreatic cancer removed and completed additional treatment to access a new personalized vaccine, PCNAT-01, if they can't join the ongoing clinical trial. The vaccine aims to lower the chance of cancer returning.

Patient Parameters

Program Overview

This program allows eligible patients with pancreatic cancer, who have had their tumors surgically removed and completed standard additional treatment, to access PCNAT-01, a new personalized vaccine. This vaccine is designed to help prevent the cancer from coming back. Access is available when joining the clinical trial is not possible. Approval is needed from the sponsor, regulatory bodies, and a review board, and the vaccine must be successfully made for each patient.

Description

PCNAT-01 is a new personalized vaccine made from synthetic peptides tailored to each patient's tumor. It is currently being tested in a Phase 1 study to check its safety and effectiveness in patients who are cancer-free after surgery and additional chemotherapy. This expanded access program is linked to the ongoing study, which is open to patients who can't join the trial but still need the vaccine to prevent cancer recurrence.

The program is for patients with a history of pancreatic cancer who are at risk of the cancer returning after standard treatment but can't participate in the ongoing trial. Access is considered when no other treatment options are available, and the potential benefits outweigh the risks.

Since PCNAT-01 is personalized, access depends on having enough tumor tissue, successful identification of neoantigens, and successful production of the vaccine. Patients must meet specific health and safety criteria before receiving the vaccine. Each request is reviewed individually by the sponsor and the patient's doctor, and treatment can only start after all necessary approvals and requirements are met.

Eligibility Criteria

Eligibility for expanded access will be determined on a case-by-case basis by the Sponsor and treating physician. Key criteria may include the following:

Inclusion Criteria

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

Exclusion Criteria

  1. Ability to participate in the ongoing PCNAT-01 clinical trial, if trial participation is feasible and appropriate.
  2. Evidence of recurrent, metastatic, or unresectable disease before planned PCNAT-01 administration, unless specifically accepted after Sponsor and physician review.
  3. Known hypersensitivity or intolerance to PCNAT-01, Poly-ICLC, or any component of the vaccine.
  4. Active uncontrolled infection or clinically significant viral infection.
  5. Active or suspected autoimmune disease requiring systemic treatment, except protocol-permitted conditions.
  6. Immunodeficiency disease, organ transplantation requiring immunosuppression, or chronic systemic immunosuppressive therapy.
  7. Clinically significant cardiovascular disease, uncontrolled hypertension, clinically significant arrhythmia, or other uncontrolled medical condition.
  8. 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.
  9. Unresolved clinically significant toxicity from prior anticancer therapy.
  10. Pregnancy or breastfeeding.
  11. 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.

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