Набор скоро начнётся NCT07686068

First-in-Human Trial of VBC106 in Participants With Advanced 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: VBC106.
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: США, Австралия
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

Phase 1/2a Open-Label Clinical Trial Evaluating VBC106, an FRα- and MSLN-Directed Bispecific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors

Обзор

This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a trial. The Phase 1 portion adopts BOIN design to identify the MTD and/or RP2D with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and to further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies for VBC106.

Вмешательства

Препарат VBC106
VBC106

Первичные конечные точки

Incidence of dose-limiting toxicities (DLT) as defined in the protocol [Срок оценки: (DLT)From time of first dose of VBC106 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 VBC106]
Incidence of Adverse Events (AEs) [Срок оценки: From time of Informed Consent to 30 days post last dose of VBC106]

Вторичные конечные точки (11)

Objective Response Rate (ORR) [Срок оценки: From date of first dose of VBC106 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 VBC106 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 VBC106 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)]
Progression free Survival (PFS) [Срок оценки: From date of first dose of VBC106 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS) [Срок оценки: From date of first dose of VBC106 up until the date of death due to any cause (approximately 2 years)]
Pharmacokinetics of VBC106 [Срок оценки: From date of first dose of VBC106 up until 30 days post last dose]
Pharmacokinetics of VBC106: Area under the concentration time curve (AUC) [Срок оценки: From date of first dose of VBC106 up until 30 days post last dose]
Pharmacokinetics of VBC106: Maximum plasma concentration of the study drug (C-max) [Срок оценки: From date of first dose of VBC106 up until 30 days post last dose]
Pharmacokinetics of VBC106: Time to maximum plasma concentration of the study drug (T-max) [Срок оценки: From date of first dose of VBC106 up until 30 days post last dose]
Pharmacokinetics of VBC106: Half-life [Срок оценки: From date of first dose of VBC106 up until 30 days post last dose]
Immunogenicity of VBC106: Anti-Drug Antibodies (ADA) [Срок оценки: From date of first dose of VBC106 up until 30 days post last dose]

Критерии участия

Критерии включения

\- A participant must meet all of the following inclusion criteria to be eligible to participate in this trial:
1\. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.
2\. Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment, or standard therapies are not appropriate or not safe in the opinion of the Investigator or refused by the participant.
3\. At least one measurable lesion as assessed according to RECIST v1.1 criteria for participants with non-pleural mesothelioma or other solid tumors and modified RECIST(mRECIST) for participants with malignant pleural mesothelioma.
4\. Male or female adults (defined as ≥ 18 years of age)
5\. ECOG performance status 0-1
6\. Has LVEF ≥ 50% by either ECHO or MUGA within 28 days before enrollment.
7\. Life expectancy greater than 12 weeks
8\. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.
9\. Adequate organ and bone marrow function

Критерии исключения

Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.
Known or suspected brain metastases, or spinal cord compression.
Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
Has a history of underlying pulmonary disorder including.
History of chronic, active, or hereditary corneal disease.
Participant history of congestive heart failure (CHF) Class II-IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет