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Идёт набор NCT06921837

A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer

Фаза I / Фаза II С лечением Gastric Cancer Adenocarcinoma Metastatic Gastroesophageal Adenocarcinoma

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: BDC-4182.
Кому может быть актуально
Состояния в реестре: Gastric Cancer Adenocarcinoma Metastatic, Gastroesophageal Adenocarcinoma. 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
Австралия, South Korea, Тайвань
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 1/2, First-in-Human, Dose Escalation and Expansion Study of BDC-4182 as a Single Agent in Patients With Advanced Gastric and Gastroesophageal Cancer

Обзор

A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers

Подробное описание

This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.

Вмешательства

  • Препарат BDC-4182
    Immune stimulating antibody conjugate (ISAC), consisting of an anti-claudin 18.2 monoclonal antibody conjugated to a TLR 7/8 dual agonist

Первичные конечные точки

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0 [Срок оценки: approximately 2 years]
  • Incidence and nature of AEs considered by the Investigator or Sponsor to be clinically relevant, attributable to study treatment, and meeting dose-limiting toxicity (DLT) criteria [Срок оценки: Up to 21 days]
Вторичные конечные точки (12)
  • Objective response rate (ORR) according to RECIST v. 1.1 [Срок оценки: approximately 4 years]
  • Duration of Response (DOR) [Срок оценки: approximately 4 years]
  • Disease control rate (DCR) [Срок оценки: approximately 4 years]
  • Progression-free survival (PFS) [Срок оценки: approximately 4 years]
  • Best Overall Response (BOR) [Срок оценки: approximately 4 years]
  • Overall survival (OS) [Срок оценки: approximately 4 years]
  • PK (Cmax) of BDC-4182 [Срок оценки: approximately 4 years]
  • PK (Cmin) of BDC-4182 [Срок оценки: approximately 4 years]
  • PK (AUC0-tau) of BDC-4182 [Срок оценки: approximately 4 years]
  • PK (AUC0-inf) of BDC-4182 [Срок оценки: approximately 4 years]
  • PK (CL) of BDC-4182 [Срок оценки: approximately 4 years]
  • PK (Vc or Vss) of BDC-4182 [Срок оценки: approximately 4 years]

Критерии участия

Критерии включения

  • Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
  • Subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).
  • Subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
  • For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed.
  • Adequate organ function
  • Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted.

Критерии исключения

  • Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment.
  • Cardiac disease, pulmonary disease, or hepatic disease
  • Active infection
  • History of inflammatory eye disease
  • Residual toxicity from a previous treatment
  • Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Тайвань · 6 центров
  • TWN Site 9004 — Kaohsiung City
  • TWN Site 9005 — Kaohsiung City
  • TWN Site 9001 — Taichung
  • TWN Site 9003 — Taipei
  • TWN Site 9006 — Taipei
  • TWN Site 9002 — Taoyuan
Австралия · 5 центров
  • AUS Site 2 — Darlinghurst
  • AUS Site 5 — Westmead
  • AUS Site 1 — Birtinya
  • AUS Site 4 — Clayton
  • AUS Site 3 — Heidelberg
South Korea · 5 центров
  • SK Site 2003 — Seongnam-si
  • SK Site 2001 — Seoul
  • SK Site 2002 — Seoul
  • SK Site 2004 — Seoul
  • SK Site 2005 — Seoul

Идентификаторы

NCT: NCT06921837 · BBI-4182-101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗