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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Adebrelimab; Drug: mRNA tumor vaccines

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT	Percentage of subjects who meet the criteria of DLT in DLT observation period	Day 1 to Day 28 after the first tumour vaccine was administrated
MTD/MAD	Maximum tolerated dose (MTD)/Maximum administrated dose (MAD)	From first dose up to end of the study, assessed up to 36 months
RDE	Recommended dose of expansion	From first dose up to end of the study, assessed up to 36 months
AE	Percentage of subjects with Adverse Events (AEs)	From date of ICF up to end of the study, assessed up to 36 months

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Regenelead Therapies Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Estimated): December 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PANC-IIT-RGL-mRNA vaccine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No