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| Name | Class |
|---|---|
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental | Participants will receive BL-B01D1 + Abiraterone, BL-B01D1 + Olaparib, or BL-B01D1 + Abiraterone + Olaparib in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-B01D1 | Drug | Administration by intravenous infusion for a cycle of 3 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to approximately 24 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sa Xiao, PHD | Contact | 15013238943 | xiaosa@baili-pharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Medical Center of Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C089740 | abiraterone |
| C531550 | olaparib |
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| Abiraterone | Drug | Oral administration for a cycle of 3 weeks. |
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| Olaparib | Drug | Oral administration for a cycle of 3 weeks. |
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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. |
| Up to approximately 24 months |
| 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. | Up to approximately 24 months |
| 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. | Up to approximately 24 months |
| The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) | Shanghai | Shanghai Municipality | China |
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