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El ensayo clínico NCT05329766 (EDGE-Gastric) para Gastrointestinal Tract Malignancies está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric) Fase II 332
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05329766 (EDGE-Gastric) está diseñado para estudiar el tratamiento de Gastrointestinal Tract Malignancies. Es un estudio intervencionista de Fase II. Su estado actual es: activo, no reclutando. El estudio se inició el 10 de junio de 2022, con el objetivo de reclutar a 332 participantes. Dirigido por Arcus Biosciences, Inc., se espera que finalice el 1 de junio de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de febrero de 2026.
Resumen
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).
Título oficial
A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)
Condiciones médicas
Gastrointestinal Tract MalignanciesPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- EDGE-Gastric
- ARC-21
- 2021-006291-16 (Número EudraCT)
- 2024-511917-40-00 (Número CTIS (UE))
Número del NCT
Inicio del estudio (real)
2022-06-10
Última actualización
2026-02-27
Fecha de finalización (estimada)
2027-06
Inscripción (prevista)
332
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Activo, no reclutando
Palabras clave
Domvanalimab
Quemliclustat
Zimberelimab
Esophageal adenocarcinoma
Gastric adenocarcinoma
Gastric cancer
Gastroesophageal junction cancer
Anti-PD-1 antibody
Anti-CD73
anti-TIGIT antibody
Quemliclustat
Zimberelimab
Esophageal adenocarcinoma
Gastric adenocarcinoma
Gastric cancer
Gastroesophageal junction cancer
Anti-PD-1 antibody
Anti-CD73
anti-TIGIT antibody
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalA1: First Line - Treatment Naïve Participants Domvanalimab and zimberelimab once every 4 weeks (Q4W) in addition to FOLFOX chemotherapy by intravenous (IV) infusion once every 2 weeks (Q2W) | Domvanalimab Administered as specified in the treatment arm Zimberelimab Administered as specified in the treatment arm Fluorouracil Administered as specified in the treatment arm Leucovorin Administered as specified in the treatment arm Oxaliplatin Administered as specified in the treatment arm |
ExperimentalA2: First Line - Treatment Naïve Participants Zimberelimab Q4W in addition to chemotherapy with FOLFOX administered by IV infusion Q2W | Zimberelimab Administered as specified in the treatment arm Fluorouracil Administered as specified in the treatment arm Leucovorin Administered as specified in the treatment arm Oxaliplatin Administered as specified in the treatment arm |
ExperimentalA3 First Line - Treatment Naïve Participants Non-randomized A3 safety run-in cohort: Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 60 minutes in addition to FOLFOX chemotherapy via IV infusion Q2W.
After completion of A3 safety run-in cohort, participants are randomized to the A3 arm. Domvanalimab and zimberelimab co-administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W | Domvanalimab Administered as specified in the treatment arm Zimberelimab Administered as specified in the treatment arm Fluorouracil Administered as specified in the treatment arm Leucovorin Administered as specified in the treatment arm Oxaliplatin Administered as specified in the treatment arm |
ExperimentalA4 First Line - Treatment Naïve Participants Zimberelimab administered Q4W via IV infusion over 30 minutes, in addition to FOLFOX chemotherapy via IV infusion Q2W | Zimberelimab Administered as specified in the treatment arm Fluorouracil Administered as specified in the treatment arm Leucovorin Administered as specified in the treatment arm Oxaliplatin Administered as specified in the treatment arm |
ExperimentalB1: Second Line or greater Checkpoint Inhibitor Naïve Participants Domvanalimab and zimberelimab administered once every three weeks (Q3W) by IV infusion | Domvanalimab Administered as specified in the treatment arm Zimberelimab Administered as specified in the treatment arm |
ExperimentalB2: Second Line or greater Checkpoint Inhibitor Naïve Participants Quemliclustat Q2W and zimberelimab Q4W administered by IV infusion | Quemliclustat Administered as specified in the treatment arm Zimberelimab Administered as specified in the treatment arm |
ExperimentalCohort C1: Second Line or greater - Checkpoint Inhibitor Experienced Participants Domvanalimab and zimberelimab Q3W administered by IV infusion | Domvanalimab Administered as specified in the treatment arm Zimberelimab Administered as specified in the treatment arm |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Number of Participants with Adverse Events (AEs) | Up to 18 months | |
Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 18 months |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Objective Response Rate (ORR) as measured by PD-L1 Expression Level | Up to 18 months | |
Overall survival (OS) | From date of first dose until the date of death due to any cause (approximately 18 months) | |
Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 | Up to 18 months | |
Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks | Up to 18 months | |
Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 | Up to 18 months | |
Plasma concentration of domvanalimab | Up to 18 months | |
Plasma concentration of zimberelimab | Up to 18 months | |
Plasma concentration of quemliclustat | Up to 18 months | |
Percentage of participants with anti-drug antibodies to domvanalimab | Up to 18 months | |
Percentage of participants with anti-drug antibodies to zimberelimab | Up to 18 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
- Eastern cooperative oncology group (ECOG) Performance Score of 0-1
- At least one measurable target lesion per RECIST v1.1.
- Adequate organ and marrow function
- Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing
- Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
- Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
- Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
- Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
- History of trauma or major surgery within 28 days prior to enrollment.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Arcus Biosciences, Inc.Gilead Sciences183 estudios activos para explorarNo hay datos de contacto.
49 Centros del estudio en 6 países
Clínica San Carlos de Apoquindo, Las Condes, Chile
Bradford Hill Centro de Investigaciones Clinicas, Recoleta, Chile
Centro de Estudios Clínicos SAGA, Santiago, Chile
Clínica Universidad Católica del Maule, Talca, Chile
Arizona
Mayo Clinic - Arizona, Phoenix, Arizona, 85054, United States
California
USC/Norris Comprehensive Cancer Center, Los Angeles, California, 90033, United States
Ronald Reagan UCLA Medical Center, Santa Monica, California, 90024, United States
Connecticut
Yale Cancer Center, Derby, Connecticut, 06418, United States
Florida
Florida Cancer Specialist - South, Fort Myers, Florida, 33901, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States
Florida Cancer Specialist - North, St. Petersburg, Florida, 33705, United States
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02109, United States
New York
Memorial Sloan Kettering Cancer Center, New York, New York, 10021-0005, United States
Columbia University, New York, New York, 10032, United States
North Carolina
Duke University, Durham, North Carolina, 27710, United States
Ohio
Zangmeister Cancer Center, Columbus, Ohio, 43219, United States
Oklahoma
OU - Stephenson Cancer Center, Oklahoma City, Oklahoma, 73104, United States
Tennessee
SCRI Tennessee Oncology - Nashville, Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, 37232, United States
Virginia
Virginia Cancer Specialists, Fairfax, Virginia, 22031, United States
UHN - Princess Margaret Cancer Centre, Toronto, Canada
Institut Bergonié _ Bordeaux, Bordeaux, France
CHU de Brest_Brest, Brest, France
Centre Baclesse - CAEN, Caen, France
Centre Oscar Lambret _ LILLE, Lille, France
Centre Léon Bérard _ Lyon, Lyon, France
Hôpital Timone - Marseille, Marseille, France
Institut de Recherche en Cancerologie de Montpellier, Montpellier, France
Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie, Plérin, France
Pôle Régional de Cancérologie - Service d'Oncologie Médicale - Poitiers, Poitiers, France
CHU de Toulouse_Oncopole, Toulouse, France
Gustave Roussy - Villejuif, Villejuif, France
MSB - Medicinski Sistem Beograd, Belgrade, Serbia
University Clinical Center of Serbia, Belgrade, Serbia
University Hospital Medical Center (KBC) Bezanijska Kosa, Belgrade, Serbia
Institute of Oncology of Vojvodina, Kamenitz, Serbia
Clinical Center Kragujevac, Kragujevac, Serbia
Dong-A University Hospital, Busan, South Korea
Kyungpook National University Chilgok Hospital, Daegu, South Korea
Chonnam National University Hwasun Hospital, Hwasun, South Korea
CHA Bundang Medical Center, Seongnam-si, South Korea
Asan Medical Center Hospital, Seoul, South Korea
Korea University Anam Hospital, Seoul, South Korea
Korea University Guro Hospital, Seoul, South Korea
Samsung Medical Center, Seoul, South Korea
Seoul National University Hospital, Seoul, South Korea
Severance Hospital Cancer Center, Seoul, South Korea
Ajou University Hospital, Suwon, South Korea
St. Vincent's Hospital, The Catholic University of Korea, Suwon, South Korea