FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors

Summary

This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors.

Timeline

Start

2021-08-17

Primary completion

2023-12-04

Completion

2023-12-04

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Publications

• Results Livingston JA, Blay JY, Trent J, Valverde C, Agulnik M, Gounder M, Le Cesne A, McKean M, Wagner MJ, Stacchiotti S, Agresta S, Quintas-Cardama A, Reilly SA, Healy K, Hickman D, Zhao T, Ballesteros-Perez A, Khalil A, Collins MP, Piel J, Horrigan K, Lefkovith A, Innis S, Lazar AJ, Cote GM, Wagner AJ. A Phase I Study of FHD-609, a Heterobifunctional Degrader of Bromodomain-Containing Protein 9, in Patients with Advanced Synovial Sarcoma or SMARCB1-Deficient Tumors. Clin Cancer Res. 2025 Feb 17;31(4):628-638. doi: 10.1158/1078-0432.CCR-24-2583.

Drugs

Indications