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drugset / Trial / NCT05859750

A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer

NCT05859750 ↗

Phase 2 Recruiting 78 enrolled Akeso
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.

Timeline

Start
2023-05-25
Primary completion
2025-06
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 6 mg/kg Intravenous
Subject Cadonilimab Monoclonal antibody 10 mg/kg Intravenous
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject IRINOTECAN Small molecule 50 mg/m2 Intravenous
Subject Irinotecan Small molecule 180 mg/m2 Intravenous
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Nab-paclitaxel Small molecule 125 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 60 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

malignant pancreatic neoplasm