NCT05355753

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

A Phase 1/2 Open-Label, Multicenter Study to Characterize the Safety and Tolerability of CFT8634 in Subjects With Locally Advanced or Metastatic SMARCB1-Perturbed Cancers, Including Synovial Sarcoma and SMARCB1-Null Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: C4 Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This 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.

Detailed description

The study was intended to be Phase 1/2 trial but did not advance to Phase 2.

Conditions

• Synovial Sarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	CFT8634	Oral dose of CFT8634

Timeline

• Start date: 2022-03-25
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2022-05-02
• Last updated: 2024-12-17

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study