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

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: BL-B01D1; Drug: Abiraterone; Drug: Olaparib

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sa Xiao, PHD; Phone Number: 15013238943; Email: xiaosa@baili-pharm.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • The First Medical Center of Chinese PLA General Hospital
      • Contact: Xu Zhang
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)
      • Contact: Linhui Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with metastatic castration-resistant prostate cancer who are suitable for radical local therapy;
2. Patients with non-prostatic acinar adenocarcinoma confirmed by histopathology or cytology, among others;
3. Patients who have previously received antibody-drug conjugates using topoisomerase I inhibitors as the toxin, among others;
4. Use of chemotherapy, targeted therapy, biological therapy, etc., within 4 weeks or 5 half-lives prior to study randomization;
5. History of severe heart disease or cerebrovascular disease;
6. Long-term systemic corticosteroid therapy with prednisone >10 mg/day ongoing before the first dose, among others;
7. Active autoimmune diseases and inflammatory diseases;
8. Any thrombotic event within 6 months prior to randomization;
9. Prolonged QTc interval, complete left bundle branch block, etc.;
10. Diagnosis of active malignant tumors within 3 years prior to study randomization;
11. Hypertension inadequately controlled by two antihypertensive medications;
12. Patients with poorly controlled blood glucose;
13. History of ILD requiring steroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;
14. Concurrent pulmonary diseases resulting in clinically severe respiratory function impairment;
15. Patients with active central nervous system metastases;
16. Severe infection occurring within 4 weeks prior to study randomization, etc.;
17. Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;
18. Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
19. Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
20. Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
21. Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea, etc.;
22. Patients with a history of allergy to recombinant humanized antibodies or allergy to the investigational drug;
23. History of autologous or allogeneic stem cell transplantation;
24. Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
25. History of severe neurological or psychiatric disorders;
26. Receipt of other unapproved clinical investigational drugs or treatments within 4 weeks prior to study randomization;
27. Trial participants planning to receive vaccination or having received live vaccines within 28 days prior to study randomization;
28. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study treatment; 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; Administration by intravenous infusion for a cycle of 3 weeks.; Other Names: BMS-986507; iza-bren; izalontamab brengitecan; Drug: Abiraterone; Oral administration for a cycle of 3 weeks.; Drug: Olaparib; Oral administration for a cycle of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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
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
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

Collaborators and Investigators

• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
• Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: abiraterone; olaparib
• Other Study ID Numbers: BL-B01D1-214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No