Tests BL-B01D1 combination therapy in men with advanced prostate cancer
Tests BL-B01D1 with other drugs in adults with advanced, hormone-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 2/3
Where in China
- The First Medical Center of Chinese PLA General HospitalBeijing, ChinaNo longer taking part
- The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital)Shanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT07641855
- Record updated
- 23 July 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Long-term systemic corticosteroid therapy with prednisone >10 mg/day ongoing before the first dose, among others; Any thrombotic event within 6 months prior to randomization; Diagnosis of active malignant tumors within 3 years prior to study randomization; Concurrent pulmonary diseases resulting in clinically severe respiratory function impairment; Severe infection occurring within 4 weeks prior to study randomization, 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 a history of allergy to recombinant humanized antibodies or allergy to the investigational drug; 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; Patients with metastatic castration-resistant prostate cancer who are suitable for radical local therapy; History of severe heart disease or cerebrovascular disease; Active autoimmune diseases and inflammatory diseases; Hypertension inadequately controlled by two antihypertensive medications; History of ILD requiring steroid therapy, or current ILD, or grade ≥2 radiation pneumonitis; Patients with inflammatory bowel disease, history of extensive bowel resection, history of immune-related enteritis, intestinal obstruction, or chronic diarrhea, etc; 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; Other conditions deemed by the investigator as unsuitable for participation in this clinical trial due to complications or other circumstances; Prolonged QTc interval, complete left bundle branch block, etc; Patients with poorly controlled blood glucose; Patients with non-prostatic acinar adenocarcinoma confirmed by histopathology or cytology, among others; Patients with active central nervous system metastases; 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.