A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer

NCT07641855 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-B01D1-214
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

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.

Drug: BL-B01D1; Drug: Abiraterone; Drug: Olaparib

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Also known as: iza-bren, izalontamab brengitecan, BMS-986507

Study treatment

Abiraterone DRUG

Oral administration for a cycle of 3 weeks.

Study treatment

Olaparib DRUG

Oral administration for a cycle of 3 weeks.

Study treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily join this study and sign the informed consent form;
• Age ≥ 18 years;
• Expected survival time ≥ 3 months;
• Unresectable metastatic castration-resistant prostate cancer;
• Meet the definition of mCRPC according to PCWG3 criteria;
• Agree to provide archived tumor tissue specimens from primary or metastatic lesions within 3 years or fresh tissue samples;
• Meet the evaluable lesion requirement defined by any one of the following assessment criteria;
• ECOG performance status score of 0 or 1;
• Toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥ 50%;
• Organ function levels must meet the required criteria;
• Urine protein ≤ 1+ or \< 1000 mg/24h;
• All enrolled patients must use adequate barrier contraceptive measures throughout the entire treatment period and for 7 months after the end of treatment.

You may not qualify if:

• 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;
• History of severe heart disease or cerebrovascular disease;
• Long-term systemic corticosteroid therapy with prednisone \>10 mg/day ongoing before the first dose, among others;
• Active autoimmune diseases and inflammatory diseases;
• Any thrombotic event within 6 months prior to randomization;
• Prolonged QTc interval, complete left bundle branch block, etc.;
• Diagnosis of active malignant tumors within 3 years prior to study randomization;
• Hypertension inadequately controlled by two antihypertensive medications;
• Patients with poorly controlled blood glucose;
• History of ILD requiring steroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;
• Concurrent pulmonary diseases resulting in clinically severe respiratory function impairment;
• Patients with active central nervous system metastases;

Sponsors & Collaborators

• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator
• Sichuan Baili Pharmaceutical Co., Ltd.: lead

Study Sites (2)

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Interventions

abiraterone; olaparib

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (2)