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

NCT06156267 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PANC-IIT-RGL-mRNA vaccine
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Part A: Dose Escalation, Part B: Dose Expansion

EXPERIMENTAL

Drug: Adebrelimab; Drug: mRNA tumor vaccines

Interventions

Adebrelimab DRUG

Adebrelimab is a programmed death-ligand 1 antibody.

Part A: Dose Escalation, Part B: Dose Expansion

mRNA tumor vaccines DRUG

neoantigen personalized mRNA vaccines

Part A: Dose Escalation, Part B: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead
• Shanghai Regenelead Therapies Co., Ltd.: collaborator

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: December 5, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)