NCT06405425招募中2 期
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + PD-1 Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a phase II clinical study to explore the efficacy and safety of BL-B01D1 + PD-1 combination therapy in patients with locally advanced or metastatic urothelial carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects voluntarily participated in the study and signed informed consent;
- •Male or female aged ≥18 years and ≤75 years;
- •Expected survival time ≥3 months;
- •Unresectable locally advanced or metastatic urothelial carcinoma confirmed by histopathology and/or cytology;
- •Participants should not have received previous systemic therapy for locally advanced or metastatic urothelial cancer;
- •A biopsy sample of archived tumor tissue or metastatic urothelial carcinoma must be available within 3 years for PD-L1 and other testing;
- •At least one measurable lesion meeting the RECIST v1.1 definition was required;
- •The level of organ function must meet the requirements on the premise that blood transfusion and the use of any cell growth factors and/or platelet-raising drugs are not allowed within 14 days before the first dose;
- •Previous treatment-related toxicity returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- •For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
排除标准
- •Prior ADC recipients with TOPI inhibitors as toxin;
- •Palliative radiotherapy within 2 weeks before the first dose;
- •Prior immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis;
- •Use of an immunomodulatory drug within 14 days before the first dose of study drug;
- •The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- •QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- •Active autoimmune and inflammatory diseases;
- •Receiving > before the first dose; Long-term systemic corticosteroid therapy with prednisone 10mg/d;
- •Other malignant tumors that progressed or required treatment within 5 years before the first dose;
- •Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
- •History of ILD, current ILD, or suspected ILD;
- •Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
- •Screening for unstable thrombotic events requiring therapeutic intervention within the preceding 6 months; Infusion-related thrombosis was excluded;
- •Patients with active central nervous system metastases;
- •Patients with massive or symptomatic effusions or poorly controlled effusions;
- •Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;
- •Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- •HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- •Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;
- •Participated in another clinical trial within 4 weeks before the first dose;
- •Patients with superior vena cava syndrome should not be rehydrated;
- •Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;
- •Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
- •Severe unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
- •Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- •Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
- •Other circumstances considered by the investigator to be inappropriate for participation in the trial.
研究组 & 干预措施
BL-B01D1 + PD-1
Experimental
Participants receive BL-B01D1 + PD-1 as intravenous infusion for 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)
BL-B01D1 + PD-1
Experimental
Participants receive BL-B01D1 + PD-1 as intravenous infusion for 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: PD-1 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Up to approximately 24 months
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).
次要结局
- Cmax(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Tmax(Up to approximately 24 months)
- Ctrough(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)
- Progression-free survival (PFS)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
研究者
研究点 (1)
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