Clincosm LogoSign in Get a demo

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

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06156267
Collaborator
Shanghai Regenelead Therapies Co., Ltd. (Industry)
30
Enrollment
1
Location
1
Arm
37.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Mar 1, 2027

Arms and Interventions

Arm Intervention/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

Outcome Measures

Primary Outcome Measures

  1. DLT [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

  2. MTD/MAD [From first dose up to end of the study, assessed up to 36 months]

    Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)

  3. RDE [From first dose up to end of the study, assessed up to 36 months]

    Recommended dose of expansion

  4. AE [From date of ICF up to end of the study, assessed up to 36 months]

    Percentage of subjects with Adverse Events (AEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University
  • Shanghai Regenelead Therapies Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xian-Jun Yu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier:
NCT06156267
Other Study ID Numbers:
  • PANC-IIT-RGL-mRNA vaccine
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Dec 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 5, 2023