Идёт набор NCT07431281

Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

Фаза III С лечением Gastric Cancer Gastroesophageal Junction Adenocarcinoma Esophageal Cancer

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: Sonesitatug vedotin, Rilvegostomig, Nivolumab, Capecitabine.
Кому может быть актуально: Состояния в реестре: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer. 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: США, Австралия, Австрия, Бельгия, Бразилия +17
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 III, Multicentre, Randomised Controlled Study of Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in First-Line Claudin18.2-Positive, HER2-Negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)

Обзор

The purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

Подробное описание

The purpose of this Phase III study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in 1L CLDN18.2-positive, HER2-negative gastric, GEJ, and esophageal adenocarcinoma, and the clinical performance of the investigation in vitro diagnostics (IVDs). The study will include 2 cohorts to provide a treatment option for all participants that are HER2-negative and CLDN18.2-positive. Cohort 1 will evaluate sonesitatug vedotin in combination with rilvegostomig with capecitabine in participants who are CLDN18.2-positive and programmed death-ligand 1 (PD-L1) positive. Cohort 2 will evaluate sonesitatug vedotin in combination with capecitabine in participants who are CLDN18.2-positive and PD-L1 negative or immune checkpoint inhibitor (ICI) ineligible.

Вмешательства

Препарат Sonesitatug vedotin
Intravenous
Препарат Rilvegostomig
Intravenous
Препарат Nivolumab
Intravenous
Препарат Capecitabine
Oral
Препарат 5-Fluorouracil
Intravenous
Препарат Oxaliplatin
Intravenous
Препарат Zolbetuximab
Intravenous
Препарат Leucovorin
Intravenous

Первичные конечные точки

Progression Free Survival (PFS) (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]
Overall Survival (OS) (Cohort 1) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (12)

Overall Survival (OS) (Cohort 2) [Срок оценки: Up to approximately 5 years]
Overall Survival (OS) (Cohort 1) [Срок оценки: Up to approximately 5 years]
Progression Free Survival (PFS) (Cohort 1) [Срок оценки: Up to approximately 5 years]
Objective Response Rate (ORR) (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]
Duration of Response (DoR) (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]
Pharmacokinetics of sonesitatug vedotin (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]
Immunogenicity of sonesitatug vedotin (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]
Pharmacokinetics of rilvegostomig (Cohort 1) [Срок оценки: Up to approximately 5 years]
Pharmacokinetics of rilvegostomig (Cohort 1) [Срок оценки: Up to approximately 5 years]
Immunogenicity of rilvegostomig (Cohort 1) [Срок оценки: Up to approximately 5 years]
Safety and tolerability (Cohort 1 and Cohort 2) [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

Capable of giving signed informed consent
Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
Positive CLDN18.2 expression, as determined prospectively by central IHC testing
Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:

Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
ECOG performance status of 0 or 1 with no deterioration to > 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.
Minimum life expectancy of ≥ 12 weeks.
At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
Adequate organ and bone marrow function as specified in the protocol
Body weight ≥ 35 kg.
Sex and contraceptive requirements

Критерии исключения

Known HER2-positive status
Significant or unstable gastric bleeding and/or untreated gastric ulcers.
Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk are excluded.
CNS pathology
Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.
Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Cardiac abnormalities as outlined in the protocol
Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.
Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that is not well controlled
Known partial or total DPD enzyme deficiency

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: Простое слепое
Основная цель: Лечение