Study of AK112 in the Treatment of Advanced Gynecological Tumors (NCT04870177) | Clinical Trial Compass
CompletedPhase 2
Study of AK112 in the Treatment of Advanced Gynecological Tumors
China53 participantsStarted 2021-04-09
Plain-language summary
A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion Criteria:
* Be able and willing to provide written informed consent
* 18 to 75 years old of age during enrollment
* Has ECOG performance status of 0 or 1
* Has a life expectancy of at least 3 months
* Confirmed diagnosis of advanced gynaecological neoplasm
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
* Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy
* Has adequate organ functions (e.g hematology, renal, hepatic and coagulation)
* All female subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment
* Be able and willing to comply with all requirements of study participation (including all study procedures)
Exclusion Criteria:
* Known history of other malignancy (in the last 5 years) except localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, cervical carcinoma in situ, breast carcinoma in situ that has undergone curative therapy and breast carcinoma that has not recurred for \> 3 years after radical surgery
* Is currently participating in a study of an investigational agent or using an investigational device 4 weeks prior to first administration of study drug
* For patients with platinum-resistant recurrent epithe…
What they're measuring
1
Objective response rates (ORR) according to RECIST v1.1 in the FAS population