This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
Voluntarily sign the informed consent form and comply with the protocol requirements;
Be ≥18 years and ≤75 years old on the day of signing the informed consent form;
Have an expected survival time of ≥3 months;
Have histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer;
Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks before the first dose;
Previously received ADC therapy with a topoisomerase I inhibitor as the payload, or HER2-ADC therapy;
History of severe cardiovascular or cerebrovascular disease within six months before screening;
Concurrent pulmonary disease resulting in severely impaired lung function;
Parallel
BL-M07D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Liposomal Doxorubicin
DrugAdministration by intravenous infusion for a cycle of 4 weeks.
Paclitaxel
DrugAdministration by intravenous infusion for a cycle of 4 weeks.
Topotecan
DrugAdministration by intravenous infusion for a cycle of 4 weeks.
Progression-free survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Overall survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Response Rate (RR)
Response Rate (RR) is defined as the proportion of subjects whose overall response is assessed as remission according to the RECIST v1.1 and GCIG CA-125 criteria.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
