Clinical Trials

A clinical trial sponsored by industry sponsor Foghorn Therapeutics Inc. evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of FHD-609 in patients with advanced synovial sarcoma. This multicenter Phase 1 dose-escalation and expansion study has been terminated, leaving no active or recruiting clinical trials investigating the drug across additional indications or development phases.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04965753 TERMINATED
Advanced Synovial Sarcoma
Foghorn Therapeutics Inc.
 2021-08-17 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-04)

Check the FHD-609 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

FHD-609 selectively binds to and promotes the proteasomal degradation of bromodomain-containing protein 9 (BRD9), disrupting the structural integrity and chromatin-remodeling activity of the non-canonical BAF (ncBAF) complex to suppress oncogenic gene transcription. This targeted degradation leads to cell cycle arrest and inhibition of tumor proliferation, providing the rationale for evaluating FHD-609 in BRD9-dependent malignancies such as advanced synovial sarcoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.