A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC

March 30, 2025 updated by: Akeso

An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma

To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Xuhui
      • Shanghai, Xuhui, China, 200032
        • Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily signed the informed consent form and complied with protocols requirements
  • Patients with radiographically resectable primary pancreatic tumors
  • Histopathology or cytology confirmed resected PDAC with macroscopic complete resection (R0 and R1)
  • Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0
  • ECOG 0 or 1
  • Life expectancy ≥ 6 months
  • Surgical complications have recovered,
  • Adequate organ function
  • Patients with fertility are willing to use an adequate method of contraception.

Exclusion Criteria:

  • The presence of other pathologic types
  • Participating in another clinical study
  • Have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc
  • 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
  • Severe infection occurs within 4 weeks prior to the first dose
  • Requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration.
  • Acute pancreatitis or subclinical pancreatitis
  • Active autoimmune disease
  • Allergic to immunotherapies and related drugs
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Splenectomy history
  • Active tuberculosis
  • Known or highly suspected history of interstitial pneumonia.
  • Clinically significant liver disease
  • Uncontrolled or severe cardiovascular disease.
  • Severe bleeding tendency or history of coagulopathy
  • Active malignancy within the last 3 years
  • Active syphilis infection
  • Any other situations that are not suitable for inclusion in this study judged by investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pancreatic Cancer
Resectable PDAC
Biological: AK154
AK154 is neotigeon personalized mRNA vaccine
Biological: Cadonilimab
a PD-1/CTLA-4 bispecific antibody
Biological: Ivonescimab (SMT112 or AK112) Injection
a PD-1/VEGF bi-specific antibody
Drug: mFOLFORINOX
mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: Day 1 to Day 21 after the first tumour vaccine was administrated
Percentage of subjects who meet the criteria of DLT in DLT observation period
Day 1 to Day 21 after the first tumour vaccine was administrated
AE
Time Frame: From ICF up to 30days after last study treatment
Percentage of subjects with Adverse Events (AEs)
From ICF up to 30days after last study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFS
Time Frame: 2 years
Recurrence free survival（RFS）
2 years
OS
Time Frame: 2 years
Overall survival（OS）
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Collaborators

Fudan University Shanghai Cancer Center ( FUSCC )

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 22, 2025

Primary Completion (Estimated)

February 23, 2028

Study Completion (Estimated)

November 6, 2028

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK154-IIT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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