A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Solid Tumors

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of BL-ARC002 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors

Обзор

This study is an open-label, multicenter, dose-escalation and expansion, non-randomized Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-ARC002 for injection in patients with locally advanced or metastatic solid tumors.

Подробное описание

The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion phase (Phase Ib).

Вмешательства

• Препарат BL-ARC002
  Administration by intravenous infusion for a cycle of 6 weeks.

Первичные конечные точки

• Phase Ia: Dose limiting toxicity (DLT) [Срок оценки: Up to 42 days after the first dose]
• Phase Ia: Maximum tolerated dose (MTD) [Срок оценки: Up to 42 days after the first dose]
• Phase Ib: Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (11)

• 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]
• T1/2 [Срок оценки: Up to approximately 24 months]
• AUC0-t [Срок оценки: Up to approximately 24 months]
• CL (Clearance) [Срок оценки: Up to approximately 24 months]
• Ctrough [Срок оценки: Up to approximately 24 months]
• ADA (anti-drug antibody) [Срок оценки: Up to approximately 24 months]
• Phase Ib: Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Phase Ib: Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Phase Ib: Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
• Expected survival time ≥3 months;
• Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesions within the past 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
• Organ function levels must meet the required criteria;
• Coagulation function: International normalized ratio ≤1.5 and activated partial thromboplastin time ≤1.5 × upper limit of normal;
• Urine protein ≤2+ or ≤1000 mg/24 hours;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with serum pregnancy test being negative, and they must not be breastfeeding; all enrolled patients (regardless of sex) must practice adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion.

Критерии исключения

• Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
• History of serious heart disease;
• QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of another malignancy within 5 years prior to the first dose;
• Hypertension inadequately controlled by two antihypertensive medications;
• History of ILD requiring steroid therapy, current ILD, or ≥ Grade 2 radiation pneumonitis;
• Active symptoms of central nervous system metastasis;
• History of allergy to recombinant humanized or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Cumulative anthracycline dose > 360 mg/m² from prior (neo)adjuvant anthracycline-based therapy;
• Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic therapy;
• Participation in another clinical trial within 4 weeks prior to the first dose;
• Pregnancy or breastfeeding;
• Study participants with claustrophobia or any condition preventing them from lying still to complete examinations;
• Other conditions deemed by the investigator to make the participant unsuitable for this clinical 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

• Tianjin Cancer Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07591155 · BL-ARC002-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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