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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
AK104 (6mg/kg) on day 1, IV, Q2W
AK104 (10mg/kg) on day 1, IV, Q2W
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGUnion Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei, China
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
Time frame: Up to 2 years
The number of subjects experiencing adverse events (AEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
Time frame: From the subject signs the ICF to 90 days after the last dose of study treatment.
Maximum observed concentration (Cmax) of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Minimum observed concentration (Cmin) of AK104 at steady state
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Area under the curve (AUC) of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
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Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
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, 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
Shandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGShanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGZhejiang Provincial People's hospital
Hangzhou, Zhejiang, China
RECRUITINGTime frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.