Calendario›CCCC›CFT8634

CFT8634

A Study to Assess the Safety and Tolerability of CFT8634 in Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors

Ensayo de C4 Therapeutics, Inc. en Synovial Sarcoma · Soft Tissue Sarcoma (del registro, en inglés).

Más ensayos de: Sarcoma de partes blandas.

Fase

Fase 1

Estado

Interrumpido

Participantes

49

previstos

Centros

12

Fin del objetivo primario

dic 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «High levels of BRD9 degradation did not result in sufficient efficacy in heavily pre-treated synovial sarcoma and SMARCB1-null solid tumor patients treated with CFT8634 as a single agent.».

Qué mide

Frequency and severity of AEs and serious adverse events (SAEs) (From screening until at least 30 days after completion of study treatment) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is an open-label, non-randomized, first-in-human Phase 1/2 study designed to evaluate the safety and tolerability of CFT8634 in subjects with synovial sarcoma and SMARCB1-null tumors who: have received prior systemic therapy; have relapsed/refractory tumors; have unresectable or metastatic disease; and are not candidates for available therapies known to confer clinical benefit. The study will characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of CFT8634.

Más ensayos de CCCC

Todos los de CCCC, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05355753), actualizada en dic 2024.