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Идёт набор NCT07299747

Clinical Trial of VBC103 in Patients With Advanced Malignant Solid Tumors

Фаза I / Фаза II С лечением Participants With Advanced Solid Tumor Malignancies

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: VBC103.
Кому может быть актуально
Состояния в реестре: Participants With Advanced Solid Tumor Malignancies. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase I/IIa Clinical Study Evaluating the Bispecific Antibody-Drug Conjugate VBC103 Targeting Nectin-4 and TROP2 in Subjects With Advanced Malignant Solid Tumors

Обзор

This study is a multicenter, open-label, multi-dose, first-in-human (FIH) Phase I/IIa study to determine the safety and tolerability of VBC103, as well as the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D), PK and further evaluate its efficacy.

Подробное описание

Protocol Version：V1.1 Version Date：2025-12-12

Вмешательства

  • Препарат VBC103
    VBC103

Первичные конечные точки

  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Срок оценки: (DLT)From time of first dose of VBC103 to end of DLT period (approximately 21 days)]
  • Incidence of Serious Adverse Events [Срок оценки: From time of Informed Consent to 30 days post last dose of VBC103]
Вторичные конечные точки (7)
  • Objective Response Rate (ORR) [Срок оценки: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
  • Duration of Response (DOR) [Срок оценки: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)]
  • Disease Control Rate (DCR) at 12 weeks [Срок оценки: From date of first dose of VBC103 up until progression, or the last evaluable assessment in the absence of progression (for each patient this is expected to be measured at 12 weeks)]
  • Pharmacokinetics of VBC103: Plasma PK concentrations [Срок оценки: From date of first dose of VBC103 up until 30 days post last dose]
  • Pharmacokinetics of VBC103: Maximum plasma concentration of the study drug (C-max) [Срок оценки: From date of first dose of VBC103 up until 30 days post last dose]
  • Pharmacokinetics of VBC103: Time to maximum plasma concentration of the study drug (T-max) [Срок оценки: From date of first dose of VBC103 up until 30 days post last dose]
  • Immunogenicity of VBC103: Anti-Drug Antibodies (ADA) [Срок оценки: From date of first dose of VBC103 up until 30 days post last dose]

Критерии участия

Критерии включения

  • 1.The subject or their legal representative is willing and able to sign a written ICF before initiating any study procedures.
  • 2.Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has recurred or progressed during or after standard systemic therapy, or is intolerant to standard therapy, or lacks standard treatment options (applicable only to Phase I and Phase IIa Cohort 5).
  • 3.At least one measurable lesion as assessed by the investigator per RECIST v1.1.
  • 4.Adult male or female (defined as ≥18 years of age)
  • 5.ECOG performance status score of 0-1.
  • 6.LVEF ≥50% as measured by ECHO or MUGA within 28 days prior to enrollment.
  • 7.Life expectancy exceeding 12 weeks.
  • 8.Availability of archived tumor tissue samples or willingness to undergo biopsy sampling.

Критерии исключения

  • 1.Any unresolved ≥Grade 2 toxicity from prior anticancer therapy.
  • 2.Known active keratitis or corneal ulcer.
  • 3.History of interstitial lung disease (e.g., non-infectious interstitial pneumonia, pneumonitis,pulmonary fibrosis, or severe radiation pneumonitis), current interstitial lung disease, or suspected interstitial lung disease based on imaging during the screening period.
  • 4.History of underlying pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to the start of investigational product, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, and other clinically significant pulmonary impairment or requiring supplemental oxygen, as well as any autoimmune, connective tissue, or inflammatory disease involving the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) and/or prior pneumonectomy (complete resection).

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
  • Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07299747 · VBC103-01-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗