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FHD-609 for Synovial Sarcoma
Phase 1
Waitlist Available
Research Sponsored by Foghorn Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects must meet specific criteria related to vasectomy or contraception.
Subject must meet specific renal function criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 54 months
Awards & highlights
Study Summary
This trial is testing a new drug, FHD-609, on patients with synovial sarcoma. The goal is to see if it is safe and works well against the cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to IV administration or those typical for cancer treatments such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man following specific birth control measures or have had a vasectomy.
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My kidney function meets the required levels.
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My veins are suitable for IV treatments and blood tests.
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My liver is functioning within the required range.
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I meet the study's requirements regarding menopause, sterilization, or contraception.
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My blood test results meet the required levels.
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My heart is functioning within the required range.
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I am at least 18 years old or at least 16 with a weight of 50 kg or more.
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I meet the specific physical ability criteria required.
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I have been diagnosed with SS or a tumor that lacks SMARCB1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 54 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 54 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs), serious adverse events (SAEs) including changes in safety laboratory parameters and AEs leading to discontinuation
Incidence of dose limiting toxicities (DLTs)
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR)
Overall Survival (OS)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FHD-609Experimental Treatment1 Intervention
Up to approximately 104 patients will be enrolled in dose escalation and expansion.
Find a Location
Who is running the clinical trial?
Foghorn Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
269 Total Patients Enrolled
Sarah Reilly, MDStudy DirectorFoghorn Therapeutics
2 Previous Clinical Trials
269 Total Patients Enrolled
Sam Agresta, MDStudy DirectorFoghorn Therapeutics
1 Previous Clinical Trials
36 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man following specific birth control measures or have had a vasectomy.My kidney function meets the required levels.My veins are suitable for IV treatments and blood tests.My liver is functioning within the required range.I have never been treated with a BRD9 degrader.I meet the study's requirements regarding menopause, sterilization, or contraception.I am willing and able to follow the study's schedule and treatment plans.My blood test results meet the required levels.I am not on high doses of steroids for another health issue.I do not have any unmanaged health or mental conditions.My heart is functioning within the required range.I do not have any severe infections right now.I am at least 18 years old or at least 16 with a weight of 50 kg or more.I do not have HIV or specific viral infections.I meet the specific physical ability criteria required.I have brain metastases but meet specific conditions for this trial.I do not have any other cancers that could affect this study.I have been diagnosed with SS or a tumor that lacks SMARCB1.
Research Study Groups:
This trial has the following groups:- Group 1: FHD-609
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has FHD-609 gained regulatory clearance from the FDA?
"The safety of FHD-609 is deemed low with a rating of 1, as this trial is currently in its first phase. There are limited studies that have been conducted to assess the drug's efficacy and safety."
Answered by AI
What is the scope of this clinical trial's implementation across hospitals?
"This medical trial is currently underway at 8 different sites, some of which are located in Boston, Duarte and Nashville. To reduce travel demands, it may be beneficial to join a nearby clinical site if you choose to participate."
Answered by AI
What is the fundamental goal of this clinical experiment?
"This trial aims to monitor the emergence of adverse events over a 6 week period. Secondary objectives include measuring Time to Response, Objective Response Rate and Overall Survival during this interval."
Answered by AI
To what extent has recruitment for this research project been successful?
"Affirmative. Information on clinicaltrials.gov reveals that this investigation is actively enrolling participants, which was initially posted on August 17th 2021 and last edited November 7th 2022. A total of 104 individuals will be recruited from 8 different areas for the trial."
Answered by AI
Are there any unfilled vacancies available for participants in this experiment?
"Affirmative. According to data from clinicaltrials.gov, this research protocol posted on August 17th 2021 is still actively recruiting patients. A total of 104 participants are required for the trial at 8 separate locations."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
City of Hope
What portion of applicants met pre-screening criteria?
Met criteria
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