Expanded Access to PCNAT-01 for Patients With Resected Pancreatic Ductal Adenocarcinoma Following… (NCT07612930) | Clinical Trial Compass
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Expanded Access to PCNAT-01 for Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Adjuvant Therapy
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT07612930
SponsorAnda Biopharmaceutical Development (Shenzhen) Co., Ltd.
. Availability of adequate tumor tissue for sequencing and neoantigen identification.
Exclusion criteria
. 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.