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

NCT04965753 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Advanced Synovial Sarcoma

Interventions

DRUG

FHD-609

FHD-609 as a single, intravenously administered agent given twice-weekly (BIW). Alternative dosing regimens may be evaluated.

Sponsors & Collaborators

  • Foghorn Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Reilly, MD · Foghorn Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2023-12-04
Completion
2023-12-04
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965753 on ClinicalTrials.gov