Advanced Synovial SarcomaPhase 1NCT04965753
FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors
A Phase 1 study testing FHD-609 in people with Advanced Synovial Sarcoma, run by Foghorn Therapeutics Inc. at 12 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Advanced Synovial Sarcoma
- What is being tested?
- FHD-609
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 17 Aug 2021to 4 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject must be ≥ 18 or ≥ 16 years of age with a minimum body weight of 50 kg.
- Subject must have a diagnosis of SS or a SMARCB1-loss tumor:
- SS:
- Evidence of the SS18-SSX rearrangement and/or a confirmed pathologic diagnosis of SS must be available.
- May be treatment naïve or previously treated (see definition below)
- SMARCB1-loss tumor:
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- A solid tumor primarily characterized by SMARCB1 loss (eg, malignant rhabdoid tumors, epithelioid sarcoma, poorly differentiated chordoma) Documentation of biallelic SMARCB1 alterations and/or corresponding protein loss, and/or a confirmed pathologic diagnosis of a solid tumor primarily characterized by SMARCB1 loss, must be available.
- Other solid tumors with SMARCB1 loss. Documentation of biallelic SMARCB1 alterations and/or corresponding protein loss must be available.
- Note: Inclusion criterion 15 provides timing requirements for prior therapy.
- Subject must have measurable disease by RECIST v1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥ 10 mm with calipers and/or CT scan. Measurable lesions cannot have undergone any local treatment or radiation unless the lesion has progressed post treatment nor can any local treatment or radiation involving measurable lesions be anticipated. Exceptions to the requirements for measurable disease may be made in discussion with the sponsor.
- Subject or his/her parent or legal guardian (when applicable) must be able to understand and be willing to sign an informed consent and, when applicable, subject must sign assent form.
- Subject must be willing and able to comply with scheduled study visits and treatment plans.
- Subject must be willing to undergo all study procedures (biopsies at baseline, at least 1 on-treatment and at EOT [unless contraindicated due to medical risk; other exceptions to this are at the discretion of the Sponsor]), laboratory testing, and imaging approximately every 8 (or 12) weeks independent of dose delays, interruptions, and/or reductions.
- Subject must have an ECOG PS of ≤ 2.
- Arm 2 (Dose Expansion Phase): Subject must have an ECOG PS of ≤ 3
- Subject must have a life expectancy of ≥ 3 months.
- Arm 2 (Dose Expansion Phase): Subject must have a life expectancy of ≥ 2 months
- Subject must have adequate venous access for IV drug administration and blood collection.
- Subject must have adequate cardiac function as evidenced by:
- LVEF of ≥ 40% by ECHO. Other methods of evaluating LVEF may be performed according to institutional practice.
- Corrected QT interval (QTc) using Fridericia's formula (QTcF) < 470 msec
- Subject must have adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 3.0 × ULN for subjects with Gilbert's syndrome)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3.0 × ULN (≤ 5.0 × ULN if liver metastases are present)
- Alkaline phosphatase (ALP) ≤ 3.0 × ULN (≤ 5.0 × ULN if liver metastases are present and/or known bone disease is present)
- No known portal vein thrombosis
- Subject must have adequate renal function as evidenced by:
- Glomerular filtration rate (GFR) ≥ 50 mL/min (based on a contemporary, widely accepted, and clinically applicable equation that estimates glomerular filtration rate or a measure of glomerular filtration rate [e.g. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)])
- Subject must have adequate hematologic function as evidenced by:
- Hemoglobin ≥ 8 g/dL (Red blood cell [RBC] transfusions to achieve this level will be permitted up to 7 days prior to start of study drug and complete blood count [CBC] criteria for eligibility are confirmed within 24 hours of first study dose.)
- White blood cells (WBCs) ≥ 2.0 × 109/L
- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L
- Platelets > 50 × 109/L (Transfusions to achieve this level will be allowed up to 72 hours prior to start of study drug.)
- Subject must have adequate coagulation function as evidenced by:
- International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN and partial thromboplastin time (PTT) ≤ 1.5 × ULN if not receiving anticoagulation therapy.
- Note: For subjects on anticoagulants, exceptions to these parameters are allowed if they are within the intended or expected range for their therapeutic use. Participants must have no history of clinically significant active bleeding (within 14 days of first dose of study drug) or pathological condition that carries high risk of bleeding (for example, tumor involving major vessels or known esophageal varices).
- Timing requirements with respect to prior therapy and surgery are as follows:
- At least 2 weeks or at least 5 half-lives, whichever is shorter, must have elapsed since administration of the last dose of any prior anticancer therapy (including investigational agents).
- Subjects must be recovered from any clinically relevant effects of major surgery, laparoscopic procedure, or significant traumatic injury. Note: Central line placement, subcutaneous port placement, core biopsy, fine needle aspiration, and bone marrow biopsy/aspiration are not considered major surgeries.
- For subjects who have received radiation therapy within 2 weeks of study start, health status must have returned to pre-radiation therapy baseline, and/or be adequate for study start, in the opinion of the Investigator. Radiation therapy cannot involve target lesions unless approved by the Sponsor.
- Clinically significant toxicity related to prior therapy must have returned to ≤ Grade 1 by CTCAE by approximately 14 days prior to study start. Exceptions include Grade 2 alopecia and other Grade 2 toxicities determined to be stable and irreversible by the Investigator, and other well-controlled/stable toxicities, with approval of the Sponsor.
- Female subjects must be:
- Postmenopausal, defined as at least 12 months post-cessation of menses (without an alternative medical cause); or
- Permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy or having a female partner as affirmed by the subject; or
- Nonpregnant, non-breastfeeding, and if sexually active having agreed to use a highly effective method of contraception (ie, hormonal contraceptives associated with inhibition of ovulation or intrauterine device [IUD], or intrauterine hormone-releasing system [IUS], or sexual abstinence) from Screening Visit until 187 days after final dose of study drug.
- Male subjects must have documented vasectomy or if sexually active must agree to use a highly effective method of contraception with their partners of childbearing potential (ie, hormonal contraceptives associated with the inhibition of ovulation or IUD, or IUS, or sexual abstinence) from Screening until 97 days after final dose of study drug. Male subjects must agree to refrain from donating sperm during this time period.
Who cannot join
- Subject (or parent or legal guardian, when applicable) is unable to provide informed consent (or assent, when applicable) and/or to follow protocol requirements.
- Subject has other malignancy which may interfere with the diagnosis and/or treatment of SS/SMARCB1-loss tumors and/or interpretation of outcome results.
- Subject has an active severe infection requiring systemic therapy. Subject is permitted to enroll once any required antibiotic and/or antifungal therapy has been completed and/or infection is determined to be controlled.
- Subject has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections; subjects with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Subject has known positive human immunodeficiency virus (HIV) antibody results or acquired immunodeficiency syndrome (AIDS)-related illness; subjects with CD4+ T-cell counts ≥ 350 cells/µL will be permitted, as will subjects who have not had an AIDS-related illness within the past 12 months.
- Subject has an uncontrolled concurrent medical disease and/or psychiatric illness/social situation that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol.
- Subject is requiring clinically significant or increasing doses of systemic steroid therapy for acute illness (stable doses for controlled chronic disease or symptoms are permitted) or any other systemic immunosuppressive medication. Stable doses of systemic immunosuppressive medications may be allowed with Sponsor approval. Local or targeted steroid and immunosuppressive therapies (eg, inhaled or topical steroids) are acceptable. See Exclusion criterion 7 for details on steroids in the setting of central nervous system (CNS) disease.
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- Subjects with known CNS metastases are only permitted under the following conditions: Brain metastases must have been stable for approximately 2 months since completion of most recent CNS-directed intervention. Subject may be receiving corticosteroids so long as the dose is stable or decreasing at the time of study entry. Anti-epileptic therapy is allowed so long as medications are not otherwise excluded and seizures have been controlled for approximately 4 weeks since the last anti-epileptic medication adjustment. Subjects with active brain metastases and/or leptomeningeal disease are excluded. Exceptions to this may be made on a case-by-case basis with approval of Sponsor.
- Dose Escalation Phase: Subjects with known CNS metastases that meet the above conditions are permitted to enroll in dose escalation.
- Arm 1 and Arm 3 (Dose Expansion Phase): Subjects with known or suspected CNS metastases are excluded from Arm 1 and Arm 3.
- Arm 2 (Dose Expansion Phase): Subjects with CNS metastases that meet the above conditions are permitted to enroll in Arm 2.
- Subject has known hypersensitivities to components of FHD-609.
- Subject has prior exposure to a BRD9 degrader.
- Subject is participating in any other clinical trials. Exceptions include participation in any observational or nontherapeutic clinical trials.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami Health System
Miami, Florida, 33136
Sarah Cannon Research Institute
Nashville, Tennessee, 37205
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
France2 sites
Centre Leon Berard
Lyon, 69008
Institut Gustave Roussy
Villejuif, 94805
About this study
Official 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
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.
Read the detailed description
This study is an ascending multiple dose clinical trial with expansion arms. It is primarily intended to evaluate the safety and tolerability of FHD-609 when administered intravenously to subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors. The Dose Escalation Phase will allow for the determination of the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of FHD-609. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-609.
The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-609, including toxicities that may occur less frequently, and an assessment of anti-tumor activity. The data from this study in subjects with advanced synovial sarcoma, including safety, tolerability, PK/PD findings, and anti-tumor activity, will form the basis for subsequent clinical development of FHD-609.
- Conditions
- Advanced Synovial Sarcoma
- Being tested
- FHD-609
- Keywords
- advanced synovial sarcoma, synovial sarcoma, SS, phase 1, FHD-609, BRD9, Foghorn, Foghorn Therapeutics, SMARCB1 loss, INI1 loss, poorly differentiated chordoma, epithelioid sarcoma, malignant rhabdoid tumor, SMARCB1, INI1
- Medical subject headings
- Sarcoma, Synovial, Sarcoma, Rhabdoid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FHD-609Drug
FHD-609 as a single, intravenously administered agent given twice-weekly (BIW). Alternative dosing regimens may be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| FHD-609 | Experimental | Up to approximately 104 patients will be enrolled in dose escalation and expansion. Receives: Drug: FHD-609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Dose escalation and expansion
Measured: Up to 31 months
Incidence of adverse events (AEs), serious adverse events (SAEs) including changes in safety laboratory parameters and AEs leading to discontinuation
Dose escalation and expansion
Measured: Up to 31 months
Incidence of dose limiting toxicities (DLTs)
During first 6 weeks of treatment for each patient in dose escalation
Measured: 6 weeks
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as the percentage of subjects achieving a complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Measured: Up to approximately 30 months
Duration of Response (DOR)
DOR is defined as the time from first documented evidence of CR or PR until the earliest date of documented radiological progression per RECIST 1.1. or death due to any cause among subjects who achieved a CR or PR
Measured: Up to approximately 30 months
Progression Free Survival (PFS)
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression per RECIST 1.1. or death due to any cause, whichever happens first
Measured: Up to approximately 42 months
Time to Response (TTR)
TTR is defined as the period of time from the date of first study drug administration until the first objective documentation of response per RECIST 1.1.
Measured: Up to approximately 30 months
Overall Survival (OS)
OS is defined as the time from first dose of study treatment to the date of death, irrespective of the cause of death.
Measured: Up to approximately 54 months
Plasma concentration of FHD-609 to characterize the pharmacokinetics (PK) parameters of FHD-609
Plasma concentration of FHD-609 at the scheduled timepoints
Measured: At multiple time points up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start17 Aug 2021
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Synovial SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single arm dose escalation and three-arm expansion study in patients with advanced synovial sarcoma or advanced SMARCB1-loss tumors
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foghorn Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Reilly, MD, Study director, Foghorn Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965753
- Sponsor's protocol ID
- FHD-609-C-001
- Status last verified
- Feb 2025
- First submitted
- 26 Jun 2021
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Livingston JA, Blay JY, Trent J, Valverde C, Agulnik M, Gounder M, Le Cesne A, McKean M, Wagner MJ, Stacchiotti S, Agresta S, Quintas-Cardama A, Reilly SA, Healy K, Hickman D, Zhao T, Ballesteros-Perez A, Khalil A, Collins MP, Piel J, Horrigan K, Lefkovith A, Innis S, Lazar AJ, Cote GM, Wagner AJ. A Phase I Study of FHD-609, a Heterobifunctional Degrader of Bromodomain-Containing Protein 9, in Patients with Advanced Synovial Sarcoma or SMARCB1-Deficient Tumors. Clin Cancer Res. 2025 Feb 17;31(4):628-638. doi: 10.1158/1078-0432.CCR-24-2583.
PubMed 39660994
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04965753
- Acronym / sponsor ID
- FHD-609-C-001
- Conditions
- Advanced Synovial Sarcoma
- Keywords
- advanced synovial sarcoma, synovial sarcoma, SS, phase 1, FHD-609, BRD9, Foghorn, Foghorn Therapeutics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Foghorn Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an ascending multiple dose clinical trial with expansion arms. It is primarily intended to evaluate the safety and tolerability of FHD-609 when administered intravenously to subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors. The Dose Escalation Phase will allow for the determination of the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of FHD-609. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-609.
The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-609, including toxicities that may occur less frequently, and an assessment of anti-tumor activity. The data from this study in subjects with advanced synovial sarcoma, including safety, tolerability, PK/PD findings, and anti-tumor activity, will form the basis for subsequent clinical development of FHD-609.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single arm dose escalation and three-arm expansion study in patients with advanced synovial sarcoma or advanced SMARCB1-loss tumors
| Arm | Type | Receives |
|---|---|---|
| FHD-609 | Experimental | Drug: FHD-609Up to approximately 104 patients will be enrolled in dose escalation and expansion. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (46 listed)
- Subject must be ≥ 18 or ≥ 16 years of age with a minimum body weight of 50 kg.
- Subject must have a diagnosis of SS or a SMARCB1-loss tumor:
- May be treatment naïve or previously treated (see definition below)
- Note: Inclusion criterion 15 provides timing requirements for prior therapy.
- Subject must have measurable disease by RECIST v1.1, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) as ≥ 10 mm with calipers and/or CT scan. Measurable lesions cannot have undergone any local treatment or radiation unless the lesion has progressed post treatment nor can any local treatment or radiation involving measurable lesions be anticipated. Exceptions to the requirements for measurable disease may be made in discussion with the sponsor.
Key exclusion criteria (13 listed)
- Subject (or parent or legal guardian, when applicable) is unable to provide informed consent (or assent, when applicable) and/or to follow protocol requirements.
- Subject has other malignancy which may interfere with the diagnosis and/or treatment of SS/SMARCB1-loss tumors and/or interpretation of outcome results.
- Subject has an active severe infection requiring systemic therapy. Subject is permitted to enroll once any required antibiotic and/or antifungal therapy has been completed and/or infection is determined to be controlled.
- Subject has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections; subjects with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Subject has known positive human immunodeficiency virus (HIV) antibody results or acquired immunodeficiency syndrome (AIDS)-related illness; subjects with CD4+ T-cell counts ≥ 350 cells/µL will be permitted, as will subjects who have not had an AIDS-related illness within the past 12 months.
- Subject has an uncontrolled concurrent medical disease and/or psychiatric illness/social situation that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FHD-609FHD-609 as a single, intravenously administered agent given twice-weekly (BIW). Alternative dosing regimens may be evaluated. | Drug | FHD-609 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 31 months
Dose escalation and expansion
Incidence of adverse events (AEs), serious adverse events (SAEs) including changes in safety laboratory parameters and AEs leading to discontinuation
Time frame: Up to 31 months
Dose escalation and expansion
Incidence of dose limiting toxicities (DLTs)
Time frame: 6 weeks
During first 6 weeks of treatment for each patient in dose escalation
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Duration of Response (DOR)
Time frame: Up to approximately 30 months
Progression Free Survival (PFS)
Time frame: Up to approximately 42 months
Time to Response (TTR)
Time frame: Up to approximately 30 months
Overall Survival (OS)
Time frame: Up to approximately 54 months
Plasma concentration of FHD-609 to characterize the pharmacokinetics (PK) parameters of FHD-609
Time frame: At multiple time points up to 6 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Results publication: PubMed 39660994Livingston JA, Blay JY, Trent J, Valverde C, Agulnik M, Gounder M, Le Cesne A, McKean M, Wagner MJ, Stacchiotti S, Agresta S, Quintas-Cardama A, Reilly SA, Healy K, Hickman D, Zhao T, Ballesteros-Perez A, Khalil A, Collins MP, Piel J, Horrigan K, Lefkovith A, Innis S, Lazar AJ, Cote GM, Wagner AJ. A Phase I Study of FHD-609, a Heterobifunctional Degrader of Bromodomain-Containing Protein 9, in Patients with Advanced Synovial Sarcoma or SMARCB1-Deficient Tumors. Clin Cancer Res. 2025 Feb 17;31(4):628-638. doi: 10.1158/1078-0432.CCR-24-2583.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Reilly, MD study director
Foghorn Therapeutics
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FHD-609 in people with Advanced Synovial Sarcoma, run by Foghorn Therapeutics Inc. at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, France, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to 31 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.