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

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

Overview

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.

Interventions

• Drug Adebrelimab
  Adebrelimab is a programmed death-ligand 1 antibody.
• Drug mRNA tumor vaccines
  neoantigen personalized mRNA vaccines

Primary outcome measures

• DLT [Time frame: Day 1 to Day 28 after the first tumour vaccine was administrated]
• MTD/MAD [Time frame: From first dose up to end of the study, assessed up to 36 months]
• RDE [Time frame: From first dose up to end of the study, assessed up to 36 months]
• AE [Time frame: From date of ICF up to end of the study, assessed up to 36 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Other situations that are not suitable for inclusion in this study judged by investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Canc — Shanghai

Identifiers

NCT: NCT06156267 · PANC-IIT-RGL-mRNA vaccine

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗