IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

Официальное название

IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)

Обзор

This is a Single-arm, Open-label, Phase 1b/2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Подробное описание

This trial is a phase Ib/II study to evaluate the safety, tolerability and efficacy of IBI343 in combination with sintilimab and chemotherapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In dose-escalation stage, patients with CLDN 18.2-positive, HER2-negative were treated with IBI 343, sintilimab, and chemotherapy (oxaliplatin, S-1) as first-line therapy, which followed a 3+3 design. The dose expansion stage aimed to further investigate the safety and preliminary efficacy of recommended phase II dose (RP2D), including Cohort 1 and Cohort 2. In Cohort 1, 25 patients with CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma will be enrolled. In Cohort 2, 15 patients with CLDN18.2-positive, HER2-negative gastric signet-ring cell carcinoma will be enrolled.

Вмешательства

• Препарат IBI343
  Subjects in the phase 1b stage will receive IBI343 3/4.5/6mg/kg intravenous infusion (IV) D1 Q3W in 3-week cycles. Subjects in the phase 2 stage will receive IBI343 RP2D intravenous IV D1 Q3W in 3-week cycles.
• Препарат Sintilimab
  Subjects will receive sintilimab 200mg IV D1 Q3W in 3-week cycles.
• Препарат Oxaliplatin
  Subjects will receive oxaliplatin 130mg/m2 IV D1 Q3W in 3-week cycles.
• Препарат S-1
  Subjects will receive S-1 40-60mg BID PO D1-14 Q3W in 3-week cycles.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: up to 2 years]

Вторичные конечные точки (4)

• Overall survival (OS) [Срок оценки: up to 2 years]
• Progression-free survival (PFS) [Срок оценки: up to 2 years]
• Disease control rate (DCR) [Срок оценки: up to 2 years]
• Treatment-related adverse event (TRAE) [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• 1\. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.

2\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.

3\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).

4\. No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

Критерии исключения

• 1\. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.

2\. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.

3\. Has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).

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

• Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07025889 · Dragon15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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