A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Официальное название

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Обзор

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
• Препарат PD-1 Monoclonal Antibody
  Administration by intravenous infusion for a cycle of 3 weeks (Q3W).

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (4)

• 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]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent and follow the requirements of the protocol;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• ECOG 0 or 1;
• Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;
• Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;
• A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;
• Must have at least one place in accordance with RECIST v1.1 define measurable lesions;
• No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;
• Toxicity of previous antineoplastic therapy has 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

• ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;
• Palliative radiotherapy within 2 weeks before the first dose;
• Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;
• 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 long-term systemic corticosteroid therapy, etc., before the first dose;
• 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;
• Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD;
• Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
• 6 months prior to screening needs treatment intervention unstable thrombotic events;
• Patients with active central nervous system metastases;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Allergic history 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;
• 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;
• Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
• 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: NCT06471205 · BL-B01D1-204-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗