A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Официальное название

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

Обзор

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.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion for a cycle of 3 weeks.
• Препарат PD-1
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (8)

• Progression-free survival (PFS) [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]
• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• Ctrough [Срок оценки: Up to approximately 24 months]
• Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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;
• ECOG 0-1;
• 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.

Критерии исключения

• 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 \&gt 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.

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 · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT06405425 · BL-B01D1-204-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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