Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
Sponsor: Akeso
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
78
Start Date
2023-05-25
Completion Date
2025-12
Last Updated
2024-12-16
Healthy Volunteers
No
Conditions
Interventions
AK104
AK104 (6mg/kg) on day 1, IV, Q2W
AK104
AK104 (10mg/kg) on day 1, IV, Q2W
Gemcitabine
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Nab-Paclitaxel
Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
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
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
Locations (7)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial People's hospital
Hangzhou, Zhejiang, China