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Clinical Trials in China / NCT06913218
Starting soon Phase 1

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

NCT06913218 · tracked via the Priya Life Science China tracker
Sponsor
Akeso
Phase
Phase 1
Started
2025-07-22
Last updated
2025-04-06

Condition(s) studied

Pancreas CancerPancreas Cancer, Duct Cell Adenocarcinoma

Investigational drug(s) / intervention(s)

AK154CadonilimabIvonescimab (SMT112 or AK112) InjectionmFOLFORINOX

AK154: AK154 is neotigeon personalized mRNA vaccine

Cadonilimab: a PD-1/CTLA-4 bispecific antibody

Ivonescimab (SMT112 or AK112) Injection: a PD-1/VEGF bi-specific antibody

mFOLFORINOX: mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center Shanghai Xuhui

More Akeso trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06913218 on ClinicalTrials.gov ↗ ← All trials in China