This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
999
Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGOverall response (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Disease control rate (DCR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Duration of response (DoR) assessed according to RECIST v1.1.
Time frame: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Time frame: Up to approximately 2 years
Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment.
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Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
Time frame: Up to approximately 2 years
Cmax and Cmin
AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Time frame: Up to approximately 2 years
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Time frame: Up to approximately 2 years