Pancreatic CancerEarly Phase 1NCT06156267
Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino
A Early Phase 1 study testing Adebrelimab and mRNA tumor vaccines in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Adebrelimab and mRNA tumor vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed the informed consent form and complied with protocols requirements.
- Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
- Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
- Tumour specimen availability.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Life expectancy ≥ 6 months.
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- Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3.
- Adequate marrow and organ function.
- Patients with fertility are willing to use an adequate method of contraception.
Who cannot join
- Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
- Unsuitable for immunotherapy assessed by the investigator.
- Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment.
- Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
- Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
- Known or highly suspected history of interstitial pneumonia.
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- Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines.
- Prior malignancy within 5 years prior to study entry.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known splenectomy history.
- Concurrent severe infection within 28 days prior to initiation of study treatment.
- Congenital or acquired immune deficiency.
- Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay).
- Uncontrolled or severe cardiovascular disease.
- Other situations that are not suitable for inclusion in this study judged by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma
This is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- Adebrelimab, mRNA tumor vaccines
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Adebrelimab is a programmed death-ligand 1 antibody.
mRNA tumor vaccinesDrug
neoantigen personalized mRNA vaccines
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation, Part B: Dose Expansion | Experimental | Not described Receives: Drug: Adebrelimab; Drug: mRNA tumor vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Percentage of subjects who meet the criteria of DLT in DLT observation period
Measured: Day 1 to Day 28 after the first tumour vaccine was administrated
MTD/MAD
Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)
Measured: From first dose up to end of the study, assessed up to 36 months
RDE
Recommended dose of expansion
Measured: From first dose up to end of the study, assessed up to 36 months
AE
Percentage of subjects with Adverse Events (AEs)
Measured: From date of ICF up to end of the study, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Regenelead Therapies Co., Ltd.
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156267
- Sponsor's protocol ID
- PANC-IIT-RGL-mRNA vaccine
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06156267
- Acronym / sponsor ID
- PANC-IIT-RGL-mRNA vaccine
- Conditions
- Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Regenelead Therapies Co., Ltd.
- Study start
- Jan 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Dec 2023 (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 is a phase 1, open-label study to evaluate the safety and tolerability of neoantigen personalized mRNA tumour vaccine combined with Adebrelimab (a PD-L1 humanized monoclonal antibody) in patients with surgically resected pancreatic adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation, Part B: Dose Expansion | Experimental | Drug: Adebrelimab, Drug: mRNA tumor vaccines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily signed the informed consent form and complied with protocols requirements.
- Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1).
- Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0.
- Tumour specimen availability.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (15 listed)
- Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment.
- Unsuitable for immunotherapy assessed by the investigator.
- Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment.
- Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years.
- Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment.
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 |
|---|---|---|
| AdebrelimabAdebrelimab is a programmed death-ligand 1 antibody. | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
| mRNA tumor vaccinesneoantigen personalized mRNA vaccines | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
Primary outcome
DLT
Time frame: Day 1 to Day 28 after the first tumour vaccine was administrated
Percentage of subjects who meet the criteria of DLT in DLT observation period
MTD/MAD
Time frame: From first dose up to end of the study, assessed up to 36 months
Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)
RDE
Time frame: From first dose up to end of the study, assessed up to 36 months
Recommended dose of expansion
AE
Time frame: From date of ICF up to end of the study, assessed up to 36 months
Percentage of subjects with Adverse Events (AEs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Adebrelimab and mRNA tumor vaccines in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Day 1 to Day 28 after the first tumour vaccine was administrated). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 5 Dec 2023.