FHD-609 for Synovial Sarcoma

Recruiting at11 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Foghorn Therapeutics Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called FHD-609, given through an IV, in patients with severe forms of cancer. Researchers aim to see if it is safe and effective by studying how the body processes the drug and its impact on tumors.

Research Team

Sarah Reilly, MD

Principal Investigator

Foghorn Therapeutics

Eligibility Criteria

Adults (18+ or 16+ with minimum weight of 50 kg) with advanced synovial sarcoma or SMARCB1-loss tumors can join. They must have good vein access, kidney, blood, and liver function; no severe concurrent illnesses; not be pregnant/breastfeeding; use effective contraception if applicable; and have a life expectancy of at least 2-3 months depending on the study phase.

Inclusion Criteria

Subject must meet specific coagulation function criteria.

I am a man following specific birth control measures or have had a vasectomy.

My kidney function meets the required levels.

Exclusion Criteria

I have never been treated with a BRD9 degrader.

I am not on high doses of steroids for another health issue.

Subject must be able to provide informed consent and follow protocol requirements.

Treatment Details

Interventions

• FHD-609 (Other)

Trial Overview The trial is testing FHD-609, an intravenous drug for people with specific types of cancer. It's in Phase 1 to see how safe it is, what doses are tolerable, how the body processes it, its effects on the tumor (pharmacodynamics), and early signs of effectiveness.

Participant Groups

Group I: FHD-609 Experimental Treatment 1 Intervention

Up to approximately 104 patients will be enrolled in dose escalation and expansion.

Who Is Running the Clinical Trial?

Foghorn Therapeutics Inc.

Lead Sponsor

Trials

3

Recruited

280+