A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

Официальное название

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

Обзор

A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies.

Подробное описание

Phase Ib: To explore the safety and initial efficacy of BL-B01D1 in a variety of solid tumors, including recurrent or metastatic gynecological malignancies, to further identify RP2D. To evaluate the initial efficacy of BL-B01D1. The pharmacokinetic characteristics and immunogenicity of BL-B01D1 were further evaluated. Phase II: To explore the efficacy of BL-B01D1 as a single agent RP2D in patients with multiple solid tumors such as recurrent or metastatic gynecological malignancies using Phase Ib clinical studies. To evaluate the safety and tolerance of BL-B01D1. To evaluate the pharmacokinetic characteristics and immunogenicity of BL-B01D1.

Вмешательства

• Препарат BL-B01D1
  Administration by intravenous infusion

Первичные конечные точки

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

Вторичные конечные точки (12)

• Phase Ib/II: Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Phase Ib: Objective response rate (ORR) [Срок оценки: Up to approximately 24 months]
• Phase II: Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Disease control rate (DCR) [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Duration of response (DOR) [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Cmax [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Tmax [Срок оценки: Up to approximately 24 months]
• Phase Ib: T1/2 [Срок оценки: Up to approximately 24 months]
• Phase Ib: AUC0-t [Срок оценки: Up to approximately 24 months]
• Phase Ib: CL [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Ctrough [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Histologically and/or cytologically confirmed recurrent or metastatic gynecological malignancies with failed standard treatment, intolerance to standard treatment, or no current standard treatment available;
• Agree to provide archived tumor tissue specimens (10 slides) or fresh tissue samples from primary or metastatic lesions within the past 3 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women with childbearing potential, a pregnancy test (serum or urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

Критерии исключения

• Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.);
• History of severe heart disease;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia;
• Active autoimmune or inflammatory diseases;
• Other malignancies with progression or requiring treatment within 5 years prior to the first dose;
• Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) despite the use of two antihypertensive medications;
• Poorly controlled blood glucose levels;
• History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening;
• Concurrent pulmonary disease leading to clinically significant respiratory impairment;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
• Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
• History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1;
• Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Cumulative anthracycline dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
• Severe infection within 4 weeks before the first dose of the study drug; signs of active pulmonary infection within 2 weeks before the first dose;
• Participation in another clinical trial within 4 weeks before the first dose;
• Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fudan University ShangHai Cancer Center — Шанхай

Идентификаторы

NCT: NCT05803018 · BL-B01D1-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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