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Castration-resistant Prostate CancerPhase 2/3NCT07641855

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

A Phase 2/3 study testing BL-B01D1, Abiraterone and Olaparib in people with Castration-resistant Prostate Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Castration-resistant Prostate Cancer
What is being tested?
BL-B01D1, Abiraterone and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesChina
Study dates
Sep 2026to Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Severe infection occurring within 4 weeks prior to study randomization, etc.;
  • Presence of large serous cavity effusion, or serous cavity effusion with symptoms, etc.;
  • Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
  • Severe non-healing wounds, ulcers, or fractures within 4 weeks prior to signing informed consent;
  • Trial participants with clinically significant bleeding or obvious bleeding tendency within 4 weeks prior to signing informed consent;
  • Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea, etc.;
  • Patients with a history of allergy to recombinant humanized antibodies or allergy to the investigational drug;
  • History of autologous or allogeneic stem cell transplantation;
  • Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
  • History of severe neurological or psychiatric disorders;
  • Receipt of other unapproved clinical investigational drugs or treatments within 4 weeks prior to study randomization;
  • Trial participants planning to receive vaccination or having received live vaccines within 28 days prior to study randomization;
  • Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China2 sites

  • The First Medical Center of Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Xu Zhang

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

    Shanghai, Shanghai Municipality

    Linhui Wang

Other trials in China

About this study

Official title: 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.

Being tested
BL-B01D1, Abiraterone, Olaparib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-B01D1Drug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion for a cycle of 3 weeks.

  • AbirateroneDrug

    Oral administration for a cycle of 3 weeks.

  • OlaparibDrug

    Oral administration for a cycle of 3 weeks.

Study groups in NCT07641855
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants 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.
Receives: Drug: BL-B01D1; Drug: Abiraterone; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to approximately 24 months

Secondary outcomes (4)

  1. 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).

    Measured: Up to approximately 24 months

  2. 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.

    Measured: Up to approximately 24 months

  3. 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.

    Measured: Up to approximately 24 months

  4. 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.

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07641855
Sponsor's protocol ID
BL-B01D1-214
Status last verified
Jul 2026
First submitted
8 Jun 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BL-B01D1, Abiraterone and Olaparib in people with Castration-resistant Prostate Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07641855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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