Status:
NOT_YET_RECRUITING
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
Lead Sponsor:
Akeso
Collaborating Sponsors:
Fudan University
Conditions:
Pancreas Cancer
Pancreas Cancer, Duct Cell Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 6 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06913218
Start Date
July 22 2025
End Date
November 6 2028
Last Update
April 6 2025
Active Locations (1)
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1
Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China, 200032