A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AK154
- Cadonilimab
- Ivonescimab (SMT112 or AK112) Injection
- mFOLFORINOX
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Akeso
Lead sponsor
Fudan University
Collaborator
Source ClinicalTrials.gov