B013
DrugB013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
NCT Number: NCT06434610
To evaluate the efficacy and safety of B013 in patients with platinum-resistant recurrent ovarian cancer.
Interested in participating?
Request Info18 year–75 year
Female
Interventional
Phase 2
Beijing Cancer Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
B013: The subjects will receive IV dose of B013 600 mg on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Paclitaxel: 80 mg/m^2 is administered weekly on Day 1, 8, 15 of each 28-day cycle.
Placebo: The subjects will receive IV dose of placebo matched to B013 on Day 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Time frame: Approximately 2 years
From the date of randomization to the date of progression disease or death , whichever occurred first.
Time frame: Approximately 2 years
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: Approximately 2 years
DCR was defined as the percentage of participants who have achieved complete response, partial response and stable disease.
Time frame: Approximately 5 years
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause.
Time frame: Approximately 2 years
Determination of the overall survival times of all participants.
Time frame: Approximately 5 years
The incidence of adverse event (regardless of its relationship to study drug) will be classified using MedDRA and the severity of each adverse event will be graded using NCI CTCAE v5.0.
Contact information is provided by the study sponsor or research team.
Shanghai Jiaolian Drug Research and Development Co., Ltd
Industry
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of B013 Combined With Paclitaxel in the Treatment of Platinum-resistant Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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