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

Phase 1

Not yet recruiting

• Conditions: Pancreas Cancer; Pancreas Cancer, Duct Cell Adenocarcinoma
• Interventions: Biological: AK154; Biological: Cadonilimab; Biological: Ivonescimab (SMT112 or AK112) Injection; Drug: mFOLFORINOX

• Registration Number: NCT06913218
• Lead Sponsor: Akeso

Brief Summary

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

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-30
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Study Start: 2025-07-22
• Primary Completion: 2028-02-23
• Study Completion: 2028-11-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Pancreatic Cancer	AK154	Resectable PDAC
Pancreatic Cancer	Cadonilimab	Resectable PDAC
Pancreatic Cancer	mFOLFORINOX	Resectable PDAC
Pancreatic Cancer	Ivonescimab (SMT112 or AK112) Injection	Resectable PDAC

Primary Outcome Measures

Name	Time	Method
DLT	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
AE	From ICF up to 30days after last study treatment	Percentage of subjects with Adverse Events (AEs)

Secondary Outcome Measures

Name	Time	Method
RFS	2 years	Recurrence free survival（RFS）
OS	2 years	Overall survival（OS）

Trial Locations

Locations (1)

Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Xuhui, China