A First-in-human Phase I Study to Evaluate EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors.
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: EMB-15.
- Кому может быть актуально
- Состояния в реестре: Locally Advanced or Metastatic Solid Tumors. 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 First-in-Human, Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Activity of EMB-15 in Patients With Locally Advanced or Metastatic Solid Tumors
Обзор
The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
Подробное описание
This is a first-in-human (FIH), open-label, Phase I, multicenter dose escalation study to identify the RP2D and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activities of EMB-15 in adult patients with locally advanced/metastatic solid tumors who have progressed on available standard of care or for which no standard therapy exists.This is an open-label, non-randomized dose-escalation study comprising a dose-escalation phase and a dose-expansion phase. It's planned to recruit approximately 50 patients (the final number will be determined depending on the number of dose levels) with locally advanced or metastatic solid tumors. The trial consists of a screening period (Day -28 to Day -1), a step-up dose period (applicable only to doses with higher CRS risk, lasting 7 days or longer), a treatment period (28 days per cycle, up to 2 years), and a safety follow-up period (30 days after the last dose).
Вмешательства
- Биопрепарат EMB-15
EMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
Первичные конечные точки
- incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT. [Срок оценки: Screening up to follow-up (30 days after the last dose)]
- Incidence of serious adverse events (SAE) [Срок оценки: Screening up to follow-up (30 days after the last dose)]
- Incidence of dose interruptions [Срок оценки: Screening up to follow-up (30 days after the last dose)]
- Dose intensity [Срок оценки: Screening up to follow-up (30 days after the last dose)]
- The incidence of DLTs during the DLT evaluation period. [Срок оценки: First infusion to the end of Cycle 1 (each cycle is 28 days)]
Вторичные конечные точки (10)
- Area under the serum concentration-time curve (AUC) of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months]
- Maximum serum concentration (Cmax) of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months]
- Trough concentration (Ctrough) of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months]
- Average concentration over a dosing interval (Css, avg)of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months]
- Terminal half-life (T1/2) of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
- Systemic clearance (CL) of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months.]
- Steady state volume of distribution (Vss) of EMB-15 [Срок оценки: Through treatment until EOT visit, expected average 6 months]
- Progression free survival (PFS) of EMB-15 as assessed by RECIST 1.1 [Срок оценки: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months]
- Duration of response of EMB-15 as assessed by RECIST 1.1 [Срок оценки: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months]
- Incidence and titer of anti-drug antibodies stimulated by EMB-15 [Срок оценки: Up to End of Treatment Follow Up Period (30 days after the last dose)]
Критерии участия
Критерии включения
\- 1) Able to understand and willing to sign an ICF 2) Males or females with the age ≥ 18 years 3) Life expectancy > 3 months. 4) ECOG performance status 0 or 1 5) Patients must have histologically or cytologically confirmed locally advanced or metastatic solid tumors, without standard therapy.
6\) Patients must provide archived tumor samples collected within 1 year. 7) Adequate hematological and organ function.
Критерии исключения
- Patients meeting any of the following criteria will not be enrolled:
- Any prior ALPP/ALPG targeting therapy
- Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
- Active autoimmune disease or history of autoimmune disease
- Concurrent malignancy < 5 years prior to study entry
- active infection
- Severe or uncontrolled cardiovascular disease requiring treatment
- Other severe medical conditions
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
Китай · 1 центр
- Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
Идентификаторы
NCT: NCT07607054 · EMB15X101