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

Sponsor
Akeso
Study ID
NCT06913218
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pancreas Cancer
  • Pancreas Cancer, Duct Cell Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AK154 — BIOLOGICAL
    AK154 is neotigeon personalized mRNA vaccine
  • Cadonilimab — BIOLOGICAL
    a PD-1/CTLA-4 bispecific antibody
  • Ivonescimab (SMT112 or AK112) Injection — BIOLOGICAL
    a PD-1/VEGF bi-specific antibody
  • mFOLFORINOX — DRUG
    mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin

Study Details

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

Key Dates

Start date
Jul 22, 2025
Status verified
Mar 2025
Primary completion
Feb 23, 2028
Completion
Nov 6, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pancreatic Cancer
    Resectable PDAC

Primary Outcome Measure

DLT [ Time Frame: Day 1 to Day 21 after the first tumour vaccine was administrated ]

Central Contacts

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