A Clinical Study of BT02 for the Treatment of Patients With Advanced Malignant Melanoma

Официальное название

A Phase Ib Study of the Safety, Tolerability and Efficacy of BT02 for the Treatment of Patients With Advanced Malignant Melanoma

Обзор

The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with advanced melanoma,regardless of gender, aged between 18 and 75 years (inclusive). Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.

Вмешательства

• Препарат BT02
  monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Первичные конечные точки

• Adverse events [Срок оценки: Through the study completion, an average of 2 years]
• Dose limited toxicity(DLT) [Срок оценки: Through the dose escalation phase, an average of 8 months]
• Maximum tolerable dose(MTD) [Срок оценки: Through the dose escalation phase, an average of 8 months]
• Recommended phase 2 dose(RP2D) [Срок оценки: Through the study completion, an average of 2 years]

Вторичные конечные точки (8)

• Objective response rate (ORR) on tumor assessments [Срок оценки: Through the study completion, an average of 2 years]
• Progression-free survival (PFS) on tumor assessments [Срок оценки: Through the study completion, an average of 2 years]
• Overall survival (OS) [Срок оценки: Through the study completion, an average of 2 years]
• Duration of response (DoR) on tumor assessments [Срок оценки: Through the study completion, an average of 2 years]
• Disease control rate (DCR) on tumor assessments [Срок оценки: Through the study completion, an average of 2 years]
• Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level [Срок оценки: Through the study completion, an average of 2 years]
• Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level [Срок оценки: Through the study completion, an average of 2 years]
• ADA and NAb incidence [Срок оценки: Through the study completion, an average of 2 years]

Критерии участия

Критерии включения

• Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic malignant melanoma (except for uveal melanoma) who have failed in the prior systemic therapy .
• Adequate organ and hematologic function.
• At least 1 extracranial measurable lesion.
• An ECOG activity status score of 0-1.
• A life expectancy of ≥ 3 months.
• Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
• Good compliance and willingness to follow up.

Критерии исключения

• Prior to first dose, received systemic antitumor therapy , scheduled major surgical procedure within 4 weeks , received systemic immunostimulants within 5 half-lives and systemic corticosteroids or other immunosuppressive medications within 14 days.
• A history of active autoimmune disease within the past 2 years.
• A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities or LVEF<50%. A history of severe pulmonary disease that may lead to severe episodes of dyspnea.
• A severe acute or chronic infection when enrollment.
• Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• Unresolved > grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
• Clinically active CNS metastases or meningeal metastases.
• A history of other type of malignancies.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• Poor compliance.
• A history of alcohol/drugs abuse.
• Current pregnancy or breastfeeding.
• Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07107178 · BT02-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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