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Enoblituzumab Schedule 1

Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer

Ensayo de MACROGENICS INC en Melanoma · Cancer de cabeza y cuello · Cancer de pulmon no microcitico · Carcinoma urotelial.

Más ensayos de: Melanoma · Cáncer de cabeza y cuello · Cáncer de pulmón no microcítico · Carcinoma urotelial.

Fase

Fase 1

Estado

Completado

Participantes

146

previstos

Centros

20

Fin del objetivo primario

ago 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jul 2015.

Qué mide

Number of Participants With Dose-limiting Toxicities (DLT) After Administration of Enoblituzumab and Pembrolizumab or Retifanlimab (Study Day 1-42, for Cohorts 1-4.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.

Más ensayos de MGNX

Todos los de MGNX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02475213), actualizada en ago 2025.