An Exploratory, Multi-cohort Phase II Study of combination therapy of AK112 with chemotherapy and/or olaparib in platinum-sensitive ovarian cancer(PSOC)
Signs the written informed consent form.
Female participants who are at least 18 years of age on the day of signing informed consent with.
ECOG of 0 or 1.
Life expectancy ≥3 months.
Other pathological types such as mucinous cancer, sex cord stromal cell tumor, etc.
Presence of central nervous system (CNS) metastases or carcinomatous meningitis.
Subjects with uncontrollable pleural, pericardial, or peritoneal effusion requiring repeated drainage.
Subjects with other active malignancies within 3 years prior to randomization.
Sequential
AK112 low dose
Drug10mg/kg, Q3W, ivgtt
Chemotherapy
Drugivgtt
Olaparib
Drugbid, oral
AK112 high dose
Drug20mg/kg, Q3W, ivgtt
Progression-free survival (PFS) assessed by investigator per RECIST v1.1
PFS is defined as the time from the date of first dosing till the first documented disease progression Per RECIST v1.1 assessed by the investigator or death due to any cause, whichever occurs first.
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by investigator
Proportion of subjects who have a complete or partial response relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Disease control rate(DCR)assessed by investigator per RECIST v1.1
Proportion of subjects who have received response(ie complete response or partial response) or stable disease relative to baseline as assessed by investigator according to RECIST 1.1 criteria
Duration of Response (DOR) assessed by investigator per RECIST v1.1
DOR means time measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time to Response (TTR) assessed by investigator per RECIST v1.1
TTR refers to Time to Response.
