SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

Официальное название

A Phase II Study Evaluating the Efficacy and Safety of SKB315 Combination Therapy in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Обзор

This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Подробное описание

This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study will also evaluate efficacy, physical function, safety, and tolerability of SKB315 combination, as well as Pharmacokinetics (PK) of SKB315 and the immunogenicity profile of SKB315 will be evaluated as well.

Вмешательства

• Препарат Tislelizumab
  Tislelizumab will be administered as the protocol described
• Препарат SKB315 for injection
  Tislelizumab will be administered as the protocol described
• Препарат Capecitabine
  Capecitabine will be taken orally as the protocol described

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: up to 2 years]

Вторичные конечные точки (6)

• Duration of Response (DOR) [Срок оценки: up to 2 years]
• Progression Free Survival (PFS) [Срок оценки: up to 2 years]
• Overall Survival (OS) [Срок оценки: up to 2 years]
• Safety and tolerability assessed by adverse events (AEs) [Срок оценки: Until 90 days after the end of treatment]
• Time to Response (TTR) [Срок оценки: up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
• No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
• Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;
• Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
• Estimated survival ≥ 3 months as judged by the investigator;
• Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;
• Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;

Критерии исключения

• Active leptomeningeal disease or uncontrolled brain metastasis
• Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
• Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;
• Patients with active hepatitis B or hepatitis C;
• Patients have significant gastric bleeding
• The presence of clinically uncontrollable third interspace fluid
• Have clinically significant systemic diseases that may adversely affect the safety of the study;
• Patients who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the patients are not appropriate to patients in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07609667 · SKB315-II-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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