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

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

Overview

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.

Interventions

• Drug BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Drug Abiraterone
  Oral administration for a cycle of 3 weeks.
• Drug Olaparib
  Oral administration for a cycle of 3 weeks.

Primary outcome measures

• Progression-free survival (PFS) [Time frame: Up to approximately 24 months]

Secondary outcome measures (4)

• Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
• Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
• Duration of Response (DOR) [Time frame: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• The First Medical Center of Chinese PLA General Hospital — Beijing
• The First Affiliated Hospital of Naval Medical University (Shanghai Changhai Hospital) — Shanghai

Identifiers

NCT: NCT07641855 · BL-B01D1-214

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗