A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors

Официальное название

Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Patients With Malignant Solid Tumors

Обзор

This is a Phase 1 open-label study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) at dose of 5×10∧9VP、5×10∧10VP、5×10∧11VP in Patients With Malignant Solid Tumors. Subjects will be treated with a single dose of BioTTT001 Injection after the screening period.

Подробное описание

This study is a single arm, open label, single center dose escalation trial. Three study drug dosage groups are pre-set, namely 5 × 10∧9VP、5 × 10∧10VP、 5 × 10∧11VP. According to the principle of dose escalation from low to high, the "3+3" dose escalation method is adopted. In theory, in order to protect the safety of the subjects, during the DLT observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. The DLT observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the DLT observation period. At least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.

Вмешательства

• Биопрепарат BioTTT001 injection
  BioTTT001 is administered as a single Intratumoral injection. The dose groups to be infusion were 5×10\^9 VP, 5×10\^10 VP and 5×10\^11 VP based on the 3+3 dose escalation principle.

Первичные конечные точки

• Incidence of adverse events [Срок оценки: 28 days within BioTTT001 injection]
• MTD [Срок оценки: 28 days within BioTTT001 injection]

Вторичные конечные точки (7)

• Plasma Adenovirus (ADV) copies [Срок оценки: 28 days within BioTTT001 injection]
• ADV copies in various sites [Срок оценки: 28 days within BioTTT001 injection]
• Serum interleukin-12 (IL-12) level [Срок оценки: 28 days within BioTTT001 injection]
• Serum neutralizing antibody level [Срок оценки: 28 days within BioTTT001 injection]
• ORR [Срок оценки: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
• DCR [Срок оценки: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
• PFS [Срок оценки: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]

Критерии участия

Критерии включения

• Age range from 18 to 80 years old (including the threshold), no gender restrictions.
• Patients with histologically and/or cytologically confirmed malignant solid tumors, who have experienced at least one-line standard treatment failure or intolerance, or lack standard treatment options. Focus on malignancies in the head and neck, colorectal cancer, skin malignancies, and cervical cancer.
• At least one assessable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Assessed by the investigators to have lesions suitable for intratumoral injection (assessable lesions and intratumoral injection lesions can refer to the same lesion).

Критерии исключения

• Known allergy to the investigational drug or its components.
• Previous treatment with other adenovirus drugs.
• Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia).
• Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged 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

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of China Medical Univeristy — Шэньян

Идентификаторы

NCT: NCT06215846 · BJCT-01-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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