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REGN5678

A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

Ensayo de REGENERON PHARMACEUTICALS, INC. en Metastatic Castration-Resistant Prostate Cancer (mCRPC) · Clear Cell Renal Cell Carcinoma (ccRCC) (del registro, en inglés).

Fase

Fase 1/2

Estado

Reclutando pacientes

Participantes

345

previstos

Centros

24

Fin del objetivo primario

nov 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2019.

Qué mide

Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) (Through study completion, up to 5 years) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03972657), actualizada en jul 2026.