Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Официальное название

An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Обзор

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Подробное описание

Approximately 360 participants will be assigned across 4 substudies, with approximately 60 evaluable participants of the confirmed recommend dose by SRC for study intervention in each corresponding substudy/cohort.

Вмешательства

• Препарат Rilvegostomig
  an anti PD-1 and anti-TIGIT bispecific antibody; IV infusion
• Препарат Volrustomig
  an anti PD-1 and anti CTLA-4 bispecific antibody; IV infusion
• Препарат FOLFOX
  5-fluorouracil oxaliplatin, leucovorin (levoleucovorin when locally preferred and available)
• Препарат XELOX
  capecitabine and oxaliplatin
• Препарат AZD0901
  an anti Claudin18.2 ADC; IV infusion
• Препарат 5-Fluorouracil
  5-FU, IV infusion
• Препарат Capecitabine
  Oral take

Первичные конечные точки

• ORR (per RECIST 1.1 as assessed by Investigator) [Срок оценки: Through substudy completion, an average of 2 years]
• PFS6 (per RECIST 1.1 as assessed by Investigator) [Срок оценки: Through substudy completion, an average of 2 years]

Вторичные конечные точки (4)

• PFS per RECIST 1.1 as assessed by the Investigator [Срок оценки: Through substudy completion, an average of 2 years]
• OS [Срок оценки: Through substudy completion, an average of 2 years]
• other safety related endpoints [Срок оценки: Through substudy completion, an average of 2 years]
• DoR per RECIST 1.1 based on Investigator assessment. [Срок оценки: Through substudy completion, an average of 2 years]

Критерии участия

Критерии включения

• 18 years or older at the time of signing the ICF.
• Body weight > 35 kg.
• Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
• Has measurable target disease assessed by the Investigator based on RECIST 1.1.
• ECOG PS zero or one.
• Life expectancy of at least 12 weeks.
• Adequate organ and bone marrow function.
• Has central lab confirmed Claudin18.2 status at screening from archival tumour collected within past 24 months or from a fresh biopsy when Substudy 3, Substudy 4 i s open for recruitment.

Критерии исключения

• Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by in situhybridisation) or indeterminate gastric or GEJ carcinoma.
• Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
• Participants with ascites which cannot be controlled with appropriate interventions.
• Active infectious diseases, including tuberculosis, HIV infection, or hepatitis B/C.
• Uncontrolled intercurrent illness.
• Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
• History of another primary malignancy.
• Previous treatment with an immune-oncology agent.
• Previous treatment with any modalities of Claudin18.2 target therapy or MMAE exposure (when Substudy 3, Substudy 4 is open for recruitment).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Research Site — Los Angeles
• Research Site — Los Angeles
• Research Site — Baton Rouge
• Research Site — Grand Rapids
• Research Site — New Hyde Park
• Research Site — New York
• Research Site — New York
• Research Site — New York
• … и ещё 3 центра

Китай · 9 центров

• Research Site — Пекин
• Research Site — Ханчжоу
• Research Site — Ханчжоу
• Research Site — Харбин
• Research Site — Хэфэй
• Research Site — Куньмин
• Research Site — Ухань
• Research Site — Иньчуань
• … и ещё 1 центр

Тайвань · 7 центров

• Research Site — Hsinchu
• Research Site — Kaohsiung City
• Research Site — Taichung
• Research Site — Tainan
• Research Site — Taipei
• Research Site — Taipei
• Research Site — Taoyuan

Испания · 6 центров

• Research Site — Barcelona
• Research Site — Elche(Alicante)
• Research Site — L'Hospitalet de Llobregat
• Research Site — Madrid
• Research Site — Madrid
• Research Site — Santander

South Korea · 4 центра

• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul

Великобритания · 4 центра

• Research Site — Edinburgh
• Research Site — Leeds
• Research Site — London
• Research Site — Oxford

Япония · 3 центра

• Research Site — Chūōku
• Research Site — Kashiwa
• Research Site — Sunto-gun

Идентификаторы

NCT: NCT05702229 · D7986C00001 · 2024-510977-27-00 · 2022-002840-29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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