Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with PARP inhibitor in patients with recurrent ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
AK112 injection low dose+ olaparib (Lynparza®) PARP inhibitor
AK112 injection medium dose+ olaparib (Lynparza®) PARP inhibitor
AK112 injection high dose+ olaparib (Lynparza®) PARP inhibitor
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Safety endpoint: number of subjects with adverse events (AE)
An AE is any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: Up to approximately 2 years
Primary efficacy endpoint: objective response rate (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) assessed according to RECIST v1.1
Time frame: Up to approximately 2 years
Efficacy Endpoint assessed according to RECIST v1.1 : disease control rate (DCR)
DCR based on RECIST v1.1. DCR is defined as the proportion of subjects with CR, PR, or SD.
Time frame: Up to approximately 2 years
Efficacy Endpoint assessed according to RECIST v1.1 : progression-free survival (PFS)
PFS based on RECIST v1.1. PFS is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first)
Time frame: Up to approximately 2 years
Efficacy Endpoint assessed according to RECIST v1.1 : Overall survival (OS)
OS based on RECIST v1.1. OS is defined as the time from the date of randomization or first dosing date to death due to any cause
Time frame: Up to approximately 2 years
Serum PK concentrations of AK112
Serum PK concentrations of AK112 in individual subjects at different time points after AK112 administration
Time frame: Up to approximately 2 years
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To evaluate the immunogenicity of AK112: Number of subjects with anti-drug antibodies (ADA)
Immunogenicity of AK112: Number of subjects with detectable anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
To evaluate the immunogenicity of AK112: Percentage of subjects with anti-drug antibodies (ADA)
Immunogenicity of AK112: Percentage of subjects with detectable anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
To evaluate the correlation between the expression of PD-L1 and the antitumor activity of AK112 in tumor tissues
Correlation between PD-L1 and AK112 in tumor tissues
Time frame: Up to approximately 2 years
To evaluate the association between gBRCA1/2 mutation in peripheral blood and the antitumor activity of AK112 in subjects with recurrent ovarian cancer
Association between gBRCA1/2 mutation in peripheral blood and antitumor activity of AK112
Time frame: Up to approximately 2 years