A Phase I Study of FHD-609 in People with Advanced Synovial Sarcoma

Full Title

A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered FHD-609 in Subjects with Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug FHD-609 that can be given safely in people with synovial sarcoma that has gotten worse or spread to other parts of the body (metastasized). FHD-609 breaks down a protein called BRD9 that can turn on other groups of proteins and promote the growth of cancer cells. Stopping BRD9 from acting on these other proteins may stop the growth of new cancer cells. FHD-609 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

• Participants must have inoperable or metastatic synovial sarcoma.
• At least 2 weeks must pass since the completion of prior treatment and receipt of FHD-609.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for people age 16 and older with a minimum body weight of 50 kg (110 pounds).

For more information and to ask about eligibility for this study, please contact 646-497-9067.