This study will first conduct a phase II clinical study, and on the basis of the phase II clinical study, subsequent clinical research will be carried out.
Voluntarily join this study and sign the informed consent form;
Age ≥ 18 years;
Expected survival time ≥ 3 months;
Unresectable metastatic castration-resistant prostate cancer;
Patients with metastatic castration-resistant prostate cancer who are suitable for radical local therapy;
Patients with non-prostatic acinar adenocarcinoma confirmed by histopathology or cytology, among others;
Patients who have previously received antibody-drug conjugates using topoisomerase I inhibitors as the toxin, among others;
Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to study randomization;
Single group
BL-B01D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Abiraterone
DrugOral administration for a cycle of 3 weeks.
Olaparib
DrugOral administration for a cycle of 3 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.
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) is 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.
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
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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:
