Pancreatic Ductal Adenocarcinoma (PDAC)NCT07612930
Expanded Access to PCNAT-01 for Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Adjuvant Therapy
A study testing PCNAT-01 in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Anda Biopharmaceutical Development (Shenzhen) Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- PCNAT-01
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access Program for PCNAT-01, a Personalized Tumor Neoantigen Peptide Vaccine, in Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Completion of Adjuvant Chemotherapy
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.
Read the detailed description
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- PCNAT-01
- Keywords
- Pancreatic Ductal Adenocarcinoma, PDAC, Personalized Neoantigen Vaccine, Peptide Vaccine, Tumor Neoantigen, Cancer Vaccine, Recurrence Prevention, Recurrence-Free Survival, Adjuvant Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNAT-01Biological
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612930
- Sponsor's protocol ID
- PCNAT-01-2026-EAP
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for PCNAT-01, a Personalized Tumor Neoantigen Peptide Vaccine, in Patients With Resected Pancreatic Ductal Adenocarcinoma Following Surgical Resection and Completion of Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07612930
- Acronym / sponsor ID
- PCNAT-01-2026-EAP
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- Pancreatic Ductal Adenocarcinoma, PDAC, Personalized Neoantigen Vaccine, Peptide Vaccine, Tumor Neoantigen, Cancer Vaccine, Recurrence Prevention, Recurrence-Free Survival
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Anda Biopharmaceutical Development (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCNAT-01PCNAT-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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing PCNAT-01 in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Anda Biopharmaceutical Development (Shenzhen) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact H. Chen, MD (+86 021-54920606, hmchen@andabiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.