NCT05859750

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

A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	AK104	AK104 (6mg/kg) on day 1, IV, Q2W
DRUG	AK104	AK104 (10mg/kg) on day 1, IV, Q2W
DRUG	Gemcitabine	Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
DRUG	Nab-Paclitaxel	Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
DRUG	Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate	liposomal irinotecan 50 mg/m², oxaliplatin 60 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m², administered sequentially as a continuous intravenous infusion over 46 h
DRUG	Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin	oxaliplatin, 85 mg/m²; irinotecan, 180 mg/m²; leucovorin, 400 mg/m²; and fluorouracil, 400 mg/m² given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks

Timeline

• Start date: 2023-05-25
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-05-16
• Last updated: 2024-12-16

Locations

7 sites across 1 country: China