FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors
Research type
Research Study
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
IRAS ID
1007221
Contact name
Jacqueline Cinicola
Contact email
Sponsor organisation
Foghorn Therapeutics Inc.
Eudract number
2021-001488-25
Clinicaltrials.gov Identifier
Research summary
In this study, participants will be given an investigational drug called FHD-609. FHD-609 is not approved by any regulatory authority for the treatment of cancer or any other disease. Although FHD-609 has been tested in laboratory models of cancer and in animals to understand its possible side effects, this is the first study in which FHD-609 will be given to people.
In all cells in the body, protein complexes (groups of proteins) are involved in unpacking tightly wound deoxyribonucleic acid (DNA) as a means of controlling which genes are active, or “turned on”. In certain types of cancer, alterations to the function of these protein complexes result in inappropriate growth of cancer cells. Synovial sarcoma (SS) is driven by a gene fusion that leads to such an alteration. SMARCB1 is a protein that is a core component of two of such protein complexes, the loss of this protein leads to dependency on a third protein complex in SMARCB1-loss tumours.
FHD-609 breaks down a specific protein called BRD9 involved in one of these protein complexes; breaking down BRD9 may help to limit the cancer-promoting activity of the protein complex involved in SS and takes advantage of the dependency on this specific protein complex in SMARCB1 loss tumours. FHD-609 was tested in animals before giving it to humans. In these animal studies, FHD-609 was found to slow the growth of SS tumours and tumours with SMARCB1-loss, which indicates that it may have potential to help treat these tumours in humans.
The primary goal of this study is to evaluate the safety of FHD-609. The first phase, or escalation phase, of the study will determine the safe dose for the expansion phase of the study. The primary goal of the expansion phase is to further evaluate the safety of the study drug in patients with advanced SS or tumours with SMARCB1-loss. This study will also evaluate the behaviour of the study drug in the body and in the tumour(s).REC name
Wales REC 1
REC reference
23/WA/0067
Date of REC Opinion
9 May 2023
REC opinion
Further Information Unfavourable Opinion