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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

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

Идентификаторы

NCT: NCT07641855 · BL-B01D1-214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗