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Viernes 2 oct 2026SEC · NASDAQ biomédico

Calendario›INCY›retifanlimab

retifanlimab

A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Ensayo de INCYTE CORP en Locally Advanced Solid Tumors · Metastatic Solid Tumors (del registro, en inglés).

Más ensayos de: Tumor sólido metastásico.

Fase
Fase 1
Estado
Completado
Participantes
325
previstos
Centros
80
Fin del objetivo primario
may 2024
fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2016.

Qué mide

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 (del registro, en inglés) (24 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed. The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

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Todos los de INCY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03059823), actualizada en ago 2025.