A Study Of MRNA Vaccines AK154 Monotherapy Or In Combination With AK104/AK112,and Sequential MFOLFIRINOX In Surgically Resected PDAC

Study Overview

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

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

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

Pancreas Cancer
Pancreas Cancer, Duct Cell Adenocarcinoma

BIOLOGICAL: AK154
BIOLOGICAL: Cadonilimab
BIOLOGICAL: Ivonescimab (SMT112 or AK112) Injection
DRUG: mFOLFORINOX

AK154-IIT-001

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-30
First Submitted that Met QC Criteria 2025-03-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-06
First Posted (ACTUAL) 2025-04-06	Results First Posted N/A	Last Verified 2025-03

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

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

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

Primary Outcome Measures	Measure Description	Time Frame
DLT	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	Percentage of subjects with Adverse Events (AEs)	From ICF up to 30days after last study treatment

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

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

Name: Ting Liu

Phone Number: +86 (0760) 8987 3999

Email: clinicaltrials@akesobio.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

Fudan University Shanghai Cancer Center ( FUSCC )

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record