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
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Abiraterone (Drug)
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.
干预措施: BL-B01D1 (Drug)
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.
干预措施: Olaparib (Drug)