Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer

Официальное название

A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA

Обзор

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: Be 18 years or older. Have locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma Be treatment naïve for advanced or metastatic disease Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine in combination with chemotherapy is and how well people respond to it. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (nivolumab plus chemotherapy) to see which works better. The treatment will be given in repeated time periods called cycles.

Вмешательства

• Биопрепарат PF-08634404
  Participants will receive PF-08634404 intravenously.
• Препарат Chemotherapy
  Participants will receive PF-08634404 intravenously in combination with Chemotherapy.
• Биопрепарат Nivolumab
  Participants will receive Nivolumab intravenously.

Первичные конечные точки

• Phase 2: Confirmed Objective response rate (ORR) using RECIST 1.1 as assessed by investigator [Срок оценки: Approximately 4 years]
• Phase 2: Number of participants with treatment-emergent adverse events [Срок оценки: Through 90 days after the last study intervention; Approximately 4 years]
• Phase 3: Progression Free Survival (PFS) using RECIST 1.1 as assessed by BICR [Срок оценки: Approximately 4 years]
• Phase 3: Overall Survival (OS) [Срок оценки: Approximately 4 years]

Вторичные конечные точки (12)

• Phase 2: Duration of Response (DOR) using RECIST 1.1 as assessed by investigator [Срок оценки: Approximately 4 years]
• Phase 2: Progression Free Survival (PFS) using RECIST 1.1 as assessed by investigator [Срок оценки: Approximately 4 years]
• Phase 2: Overall Survival (OS) [Срок оценки: Approximately 4 years]
• Phase 2: Number of participants with laboratory abnormalities [Срок оценки: Through 90 days after the last study intervention; Approximately 4 years]
• Phase 2: Serum concentrations of PF-08634404 [Срок оценки: Approximately 21 months]
• Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-08634404 [Срок оценки: Approximately 21 months]
• Phase 3: ORR using RECIST 1.1 as assessed by BICR [Срок оценки: Approximately 4 years]
• Phase 3: ORR using RECIST 1.1 as assessed by investigator [Срок оценки: Approximately 4 years]
• Phase 3: Progression free survival (PFS) using RECIST 1.1 as assessed by investigator [Срок оценки: Approximately 4 years]
• Phase 3: DOR using RECIST 1.1 as assessed by BICR [Срок оценки: Approximately 4 years]
• Phase 3: DOR using RECIST 1.1 as assessed by investigator [Срок оценки: Approximately 4 years]
• Phase 3: PFS2 (PFS after next-line therapy) by investigator [Срок оценки: Approximately 4 years]

Критерии участия

Критерии включения

• Histological or cytological confirmed gastric, gastroesophageal junction or esophageal adenocarcinoma.
• Evidence of locally advanced or metastatic disease.
• Eastern Cooperative Oncology Group performance status (ECOG) 0-1
• No prior systemic therapy for advanced or metastatic disease.
• Adequate hepatic, liver, and renal function
• HER-2 negative status based on local testing
• PD-L1 positive status based on local testing

Критерии исключения

• Participants with known active CNS metastases, including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression
• Clinically significant risk of hemorrhage or fistula
• Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
• History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
• Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
• Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
• Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 59 центров

• Rocky Mountain Cancer Centers, LLP — Aurora
• Rocky Mountain Cancer Centers, LLP — Boulder
• Rocky Mountain Cancer Centers, LLP — Centennial
• Rocky Mountain Cancer Centers, LLP — Colorado Springs
• Rocky Mountain Cancer Centers, LLP — Colorado Springs
• Rocky Mountain Cancer Centers, LLP — Denver
• Rocky Mountain Cancer Centers, LLP — Denver
• Rocky Mountain Cancer Centers, LLP — Englewood
• … и ещё 51 центр

Израиль · 3 центра

• Rabin Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan
• Sourasky Medical Center — Tel Aviv

Тайвань · 3 центра

• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Пуэрто-Рико · 2 центра

• Pan American Center for Oncology Trials, LLC - Manati Office — Manati
• Pan American Center for Oncology Trials, LLC - Bayamón Office — Bayamón

Китай · 1 центр

• Zhongshan Hospital,Fudan University — Шанхай

Италия · 1 центр

• Istituto Europeo di Oncologia IRCCS — Milan

Япония · 1 центр

• Aichi Cancer Center — Nagoya

Идентификаторы

NCT: NCT07392892 · C6461016 · 2025-524717-86-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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