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RECRUITING
NCT05859750
PHASE2

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

Sponsor: Akeso

View on ClinicalTrials.gov

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

Interventions

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

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