Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Официальное название

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors

Обзор

A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors

Подробное описание

Overall study design:

This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.

Вмешательства

• Препарат BT02 monoclonal antibody injection
  It is expected to include 10-30 patients assigned to dose escalation cohorts.

Первичные конечные точки

• Dose Limiting Toxicity [Срок оценки: Within day 28 after administration]
• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Within day 28 after administration]
• Maximum tolerated dose [Срок оценки: Within day 28 after administration]

Вторичные конечные точки (5)

• The Pharmacokinetics characteristics of BT02 [Срок оценки: Within day 28 after administration]
• Progression-free survival (PFS) [Срок оценки: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.]
• Overall survival (OS) [Срок оценки: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.]
• Duration of response [Срок оценки: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.]
• Objective Response Rate (ORR) [Срок оценки: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.]

Критерии участия

Критерии включения

• Age ≥18 at the time of signing the informed consent form, male or female;
• Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
• Adequate organ and hematologic function;
• Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
• ECOG performance status 0\~1;
• Life expectancy ≥ 3 months;
• Good compliance and be willing to follow-up visit.

Критерии исключения

• Receive treatment before study as below:

a) Previous systematic anti-cancer therapy;

• Active or prior documented autoimmune disease within past 2 years;
• History of clinically significant cardiovascular disease;
• Significant acute or chronic infections;
• Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
• Any prior Grade≥3 irAE while receiving immunotherapy;
• Unstable brain metastasis or meningeal metastasis with clinical symptoms;
• Patients with mental disorders or poor compliance;
• Known alcohol or drug abuse;
• Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of 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

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Institute and Hospital — Пекин

Идентификаторы

NCT: NCT06404905 · BT02-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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