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Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

2024-01

2026-04

2027-03

30

Study Overview

Study of Personalized Tumour Vaccines and a PD-L1 Blocker in Patients With Surgically Resected Pancreatic Adenocarcino

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.

N/A

  • Pancreatic Cancer
  • DRUG: Adebrelimab
  • DRUG: mRNA tumor vaccines
  • PANC-IIT-RGL-mRNA vaccine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-11-08  

N/A  

2023-12-04  

2023-12-04  

N/A  

2023-12-05  

2023-12-05  

N/A  

2023-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Part A: Dose Escalation, Part B: Dose Expansion

DRUG: Adebrelimab

  • Adebrelimab is a programmed death-ligand 1 antibody.

DRUG: mRNA tumor vaccines

  • neoantigen personalized mRNA vaccines
Primary Outcome MeasuresMeasure DescriptionTime Frame
DLTPercentage of subjects who meet the criteria of DLT in DLT observation periodDay 1 to Day 28 after the first tumour vaccine was administrated
MTD/MADMaximum tolerated dose (MTD)/Maximum administrated dose (MAD)From first dose up to end of the study, assessed up to 36 months
RDERecommended dose of expansionFrom first dose up to end of the study, assessed up to 36 months
AEPercentage of subjects with Adverse Events (AEs)From date of ICF up to end of the study, assessed up to 36 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Voluntarily signed the informed consent form and complied with protocols requirements. 2. Patients with radiographically resectable primary pancreatic tumors with histopathology or cytology confirmed resected ductal pancreatic adenocarcinoma (PDAC) with macroscopic complete resection (R0 and R1). 3. Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0. 4. Tumour specimen availability. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Life expectancy ≥ 6 months. 7. Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade 3. 8. Adequate marrow and organ function. 9. Patients with fertility are willing to use an adequate method of contraception.
    Exclusion Criteria:
    1. Prior anti-PDAC therapy (e.g., chemotherapy, radiotherapy, targeted therapy, immunotherapy and therapeutic tumor vaccines) prior to initiation of study treatment. 2. Unsuitable for immunotherapy assessed by the investigator. 3. 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. 4. Have any active autoimmune disease, or have a history of autoimmune disease and have received systemic therapy in the past 2 years. 5. Active tuberculosis or a history of active tuberculosis infection within 28 days prior to initiation of study treatment. 6. Known or highly suspected history of interstitial pneumonia. 7. Allergic to research drug ingredients, or have a history of severe allergic reactions to other vaccines. 8. Prior malignancy within 5 years prior to study entry. 9. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 10. Known splenectomy history. 11. Concurrent severe infection within 28 days prior to initiation of study treatment. 12. Congenital or acquired immune deficiency. 13. Active hepatitis B (HBV-DNA≥1000IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of assay). 14. Uncontrolled or severe cardiovascular disease. 15. Other situations that are not suitable for inclusion in this study judged by investigator.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Shanghai Regenelead Therapies Co., Ltd.
  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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