Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Официальное название

An Open-label, Multicenter Phase II Clinical Study of QLS31905 for Injection Combined With QL2107 Injection and XELOX Regimen in the First-line Treatment of CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Обзор

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Подробное описание

QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.

QL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Вмешательства

• Препарат QLS31905 for Injection
  QLS31905 for Injection
• Препарат QL2107 Injection
  QL2107 Injection
• Препарат Oxaliplatin Injection
  Oxaliplatin Injection
• Препарат Capecitabine Tablets
  Capecitabine Tablets

Первичные конечные точки

• DLT [Срок оценки: up to 42 days following first dose]
• MTD [Срок оценки: up to 42 days following first dose]
• ORR (Objective Response Rate) [Срок оценки: Approximately 24 months]

Вторичные конечные точки (7)

• AE (adverse events) [Срок оценки: Approximately 24 months]
• Number of anti-drug antibody (ADA) Positive Participants [Срок оценки: Approximately 24 months]
• DOR (Duration of Response) [Срок оценки: Approximately 24 months]
• PFS (Progression Free Survival) [Срок оценки: Approximately 24 months]
• OS (Overall Survival) [Срок оценки: Approximately 24 months]
• Maximum concentration (Cmax) [Срок оценки: Approximately 24 months]
• Terminal elimination half-life (T1/2) [Срок оценки: Approximately 24 months]

Критерии участия

Критерии включения

• Subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological or cytological examination;
• Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
• No prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Критерии исключения

• Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
• Subjects had other second primary malignancies within 5 years prior to the first dose;
• Subjects with clinically significant hemorrhage within 3 months before the first dose

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06942767 · QLS31905-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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