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Clinical Trials/NCT06156267
NCT06156267
Not yet recruiting
Early Phase 1

An Exploratory Study of Neoantigen Personalized mRNA Vaccines in Combination With Adebrelimab and Sequential mFOLFIRINOX Regimen in Patients With Surgically Resected Pancreatic Adenocarcinoma

Fudan University1 site in 1 country30 target enrollmentStarted: January 2024Last updated:
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ConditionsPancreatic Cancer
InterventionsAdebrelimabmRNA tumor vaccines
DrugsAdebrelimabmRNA tumor vaccines

Overview

Phase
Early Phase 1
Status
Not yet recruiting
Enrollment
30
Locations
1
Primary Endpoint
DLT
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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, M
  • •Tumour specimen availability.
  • •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or
  • •Life expectancy ≥ 6 months.
  • •Surgical complications have recovered, or complications lower than Clavien-Dindo complication grade
  • •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.

Arms & Interventions

Part A: Dose Escalation, Part B: Dose Expansion

Experimental

Intervention: Adebrelimab (Drug)

Part A: Dose Escalation, Part B: Dose Expansion

Experimental

Intervention: mRNA tumor vaccines (Drug)

Outcomes

Primary Outcomes

DLT

Time Frame: 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

RDE

Time Frame: From first dose up to end of the study, assessed up to 36 months

Recommended dose of expansion

AE

Time Frame: From date of ICF up to end of the study, assessed up to 36 months

Percentage of subjects with Adverse Events (AEs)

MTD/MAD

Time Frame: From first dose up to end of the study, assessed up to 36 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xian-Jun Yu

Principal Investigator

Fudan University

Study Sites (1)

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