Study of Denikitug (GS-1811) Given Alone or With Nivolumab or Chemotherapy in Adults With Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
HER2-negative · Gastroesophageal Junction · Esophageal Adenocarcinoma · Gastric Adenocarcinoma
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 120 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The goal of this clinical study is to learn more about the study drug, Denikitug (DEN, GS-1811), to evaluate the efficacy and safety of Denikitug Monotherapy and Denikitug-based combinations in in participants with human epidermal growth factor receptor 2 (HER2)-Negative, unresectable, recurrent, and/or metastatic, gastroesophageal junction (GEJ), and esophageal adenocarcinomas.
The primary objective of this study is to assess the effect of DEN as a monotherapy or in combination with nivolumab (NIVO) or ramucirumab (RAM) and paclitaxel (PAC) on objective response rate (ORR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST Version1.1).
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Key Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC).
- Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local assessment using a validated immunohistochemistry assay, in situ hybridization or other amplification testing.
- Has had disease progression during or after first line of systemic therapy for advanced or metastatic gastric, GEJ, or EACs, which must have included at least one of the following:
1. Platinum- and fluoropyrimidine-based chemotherapy.
2. Therapy with an anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (anti-PD-L1) monoclonal antibody (patients with PD-L1-positive tumors must have received prior PD-1/PD-L1-based therapy).
3. Zolbetuximab or other Claudin-18 (CLDN18).2-targeted therapy, if indicated based on biomarker status.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
* Have adequate organ function.
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.
Key Exclusion Criteria:
- Active or history of autoimmune disease requiring systemic treatment within 2 years, inflammatory bowel disease (IBD) (Crohn's/ulcerative colitis), celiac disease, or noninfectious enteritis/colitis. (Physiologic hormone replacement not considered systemic treatment).
- History or current noninfectious pneumonitis/interstitial lung disease, including radiation-induced pneumonitis requiring steroids or active/recurrent pneumonitis of any etiology.
- Documented microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) disease by local polymerase chain reaction (PCR) (microsatellite status) and/or informed consent form (ICH) (mismatch repair (MMR)) assay
- (For Part 2 only) Has known history of peripheral neuropathy ≥ Grade 2 (per National Cancer Institute(NCI)-Common Tenninology Criteria for Adverse Events (CTCAE) Version 5.0).
- (For Part 2 only) Known coagulopathy that increases the risk of bleeding, bleeding diatheses. Any other Grade 3 or higher hemorrhage/bleeding event within 28 days prior to enrollment.
Prior/Concurrent Therapy or Clinical Study Experience
- Prior treatment with DEN or other C-C chemokine receptor 8 (CCR8)-targeted agents.
- Prior Lonsurf (trifluridine-tipiracil) or paclitaxel (PAC)-based regimens in the first-line setting for advanced/metastatic gastroesophageal adenocarcinoma.
- Any systemic therapy (including investigational) targeting vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) signaling pathways.
- Anticancer biologic within 4 weeks, orchemotherapy, targeted small molecule, or radiation therapy within 2 weeks prior to enrollment with unresolved adverse events (AE)s (Grade \>2). (Observational study participants are eligible).
- Prior allogenic tissue/solid organ or stem cell transplantation. (Exception: corneal transplant not requiring systemic immunosuppression is allowed).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
Part 1: Arm A: DEN (Dose A) and NIVO
Participants will receive DEN Dose A as an IV infusion in combination with NIVO as an IV infusion.
Drug: Denikitug · Drug: Nivolumab
Part 1: Arm B: DEN (Dose B) and NIVO
Participants will receive DEN Dose B as an IV infusion in combination with NIVO as an IV infusion.
Drug: Denikitug · Drug: Nivolumab
Part 1: Arm C: DEN (Dose B)
Participants will receive DEN Dose B as an IV infusion.
Drug: Denikitug
Part 2: Arm D: Safety Run-in (SRI) Cohort
Participants will receive DEN in combination with ramucirumab (RAM) and paclitaxel (PAC).
If dose for DEN is deemed safe during the SRI Cohort, the study will move forward into the Expansion Period.
Drug: Denikitug · Drug: Ramucirumab · Drug: Paclitaxel
Part 2: Arm D: Expansion Cohort
If DEN dose is deemed safe in Arm D: SRI Cohort, participants will receive DEN at recommended dose as an IV infusion in combination with RAM and PAC.
Drug: Denikitug · Drug: Ramucirumab · Drug: Paclitaxel
Denikitug DRUG
Administered Intravenously
Nivolumab DRUG
Administered Intravenously
Ramucirumab DRUG
Administered Intravenously
Paclitaxel DRUG
Administered Intravenously
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Objective Response Rate (ORR)
Plazo: Up to 4 years
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
Medidas secundarias
Duration of Response (DOR)
Plazo: Up to 4 years
DOR is defined as the time of first response CR or PR as assessed by investigator, per RECIST Version 1.1 until the date of first documented progressive disease (PD) or death, whichever comes first.
Progression-Free Survival (PFS)
Plazo: Up to 4 years
PFS is defined as the time from date of first dose until PD or death from any cause, whichever comes first as assessed by the investigator according to RECIST Version 1.1.
Overall Survival (OS)
Plazo: Up to 4 years
OS is defined as the length of time from first dose until the date of death from any cause.
Percentage of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Plazo: First dose date up to 120 days post last dose, up to 4 years.
No informado en este registro.
Percentage of Participants Experiencing Clinical Laboratory Abnormalities According to the NCI CTCAE v5.0
Plazo: First dose date up to 120 days post last dose, up to 4 years.
No informado en este registro.
Pharmacokinetic (PK) Parameter: Serum concentration of DEN
Plazo: Up to 4 years
No informado en este registro.
PK Parameter: Cmax for Denikitug
Plazo: Up to 4 years
Cmax is defined as the maximum observed concentration.
PK Parameter: AUCall for Denikitug
Plazo: Up to 4 years
AUCall is defined as the cumulative areas under the curve for all time points.
Percentage of Participants who Developed Treatment-Emergent Antidrug Antibody (ADA) Against Denikitug
Plazo: Up to 4 years
No informado en este registro.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (16)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
16 centros
Massachusetts General HospitalBoston, Massachusetts, United StatesEstado desconocido
Dana Farber Cancer Institute (DFCI)Boston, Massachusetts, United StatesEstado desconocido
New York Oncology HematologyAlbany, New York, United StatesEstado desconocido
Weill Cornell Medicine - New York Presbyterian HospitalNew York, New York, United StatesEstado desconocido
Chris O'Brien LifehouseCamperdown, New South Wales, AustraliaEstado desconocido
Royal North Shore HospitalSt Leonards, New South Wales, AustraliaEstado desconocido
Royal Brisbane and Women's HospitalHerston, Queensland, AustraliaEstado desconocido
Flinders Medical CentreBedford Park, South Australia, AustraliaEstado desconocido
Hollywood Private HospitalNedlands, Western Australia, AustraliaEstado desconocido
Centre Leon Berard, department of medical oncologyLyon, FranceEstado desconocido
Institut Paoli-Calmettes, department of medical oncologyMarseille, FranceEstado desconocido
Seoul National University HospitalSeoul, South KoreaEstado desconocido
Hospital Universitari Vall d'HebronBarcelona, SpainEstado desconocido
Hospital Universitario 12 de OctubreMadrid, SpainEstado desconocido
Hospital Universitario de NavarraPamplona, SpainEstado desconocido
Hospital Clinico Universitario de ValenciaValencia, SpainEstado desconocido
Equipo y fechas
- Patrocinador principal
- Gilead Sciences
- Inicio del estudio
- 7 ago 2026 Real
- Finalización primaria
- 2030-01 Estimado
- Finalización del estudio
- 2030-01 Estimado
- Primera publicación
- 23 abr 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
A Phase 2, Open-Label, Multicenter, Randomized Study to Evaluate Denikitug as Monotherapy or in Combination With Nivolumab or Chemotherapy in Participants With HER2-Negative, Unresectable, Recurrent, and/or Metastatic Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinomas
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026