What side effects are associated with this type of intervention?

Common treatments for Synovial Sarcoma, particularly those involving tyrosine kinase inhibitors (TKIs) like pazopanib, imatinib, and sorafenib, often result in side effects such as diarrhea, rash, fatigue, nausea, and decreased appetite. Specific toxicities can include hand-foot syndrome, hypertension, and liver dysfunction. Additionally, targeted therapies may cause skin reactions, mucositis, and hematologic abnormalities. These side effects are generally manageable but require careful monitoring.

What prior FDA approvals exist?

FDA-approved treatments for synovial sarcoma include traditional chemotherapy agents like doxorubicin and ifosfamide. Targeted therapies such as pazopanib, a tyrosine kinase inhibitor, have also been approved for advanced soft tissue sarcomas, including synovial sarcoma. Investigational treatments similar to FHD-609, which is being studied for advanced synovial sarcoma, include multitargeted tyrosine kinase inhibitors like regorafenib and cabozantinib, which have shown activity in various sarcomas. These treatments focus on inhibiting pathways critical for tumor growth and survival.

What other types of research exist?

Promising alternatives to FHD-609 for Synovial Sarcoma patients include: 1) FG-3019, a monoclonal antibody that inhibits connective tissue growth factor and has shown efficacy in mesothelioma models. 2) SLV-11199, an inhibitor of heme oxygenase activity, which has demonstrated anticancer effectiveness and sensitization to chemotherapy in various cancer cell lines. 3) Panobinostat, a pan-DAC inhibitor that has shown effectiveness in suppressing metastasis in triple-negative breast cancer by inhibiting EMT master regulators.

← Back to Search

Other

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.

Must not have

Subject must not have prior exposure to a BRD9 degrader.

Subject must not be requiring clinically significant doses of systemic steroid therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 54 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

Select...

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

Select...

My kidney function meets the required levels.

Select...

My veins are suitable for IV treatments and blood tests.

Select...

My liver is functioning within the required range.

Select...

I meet the study's requirements regarding menopause, sterilization, or contraception.

Select...

My blood test results meet the required levels.

Select...

My heart is functioning within the required range.

Select...

I am at least 18 years old or at least 16 with a weight of 50 kg or more.

Select...

I meet the specific physical ability criteria required.

Select...

I have been diagnosed with SS or a tumor that lacks SMARCB1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have never been treated with a BRD9 degrader.

Select...

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

Select...

I do not have any unmanaged health or mental conditions.

Select...

I do not have any severe infections right now.

Select...

I do not have HIV or specific viral infections.

Select...

I do not have any other cancers that could affect this study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 54 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Duration of Response (DOR)

Objective Response Rate (ORR)

Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FHD-609Experimental Treatment1 Intervention

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Synovial Sarcoma is commonly treated with surgery, radiation therapy, and chemotherapy. Chemotherapy agents like doxorubicin and ifosfamide damage the DNA of cancer cells, preventing their growth. Targeted therapies, such as tyrosine kinase inhibitors, block specific proteins that promote cancer cell proliferation. The trial FHD-609 is exploring a new treatment approach, likely targeting cancer cells in a novel way. Understanding these mechanisms helps in selecting effective treatments and managing side effects, which is crucial for improving patient outcomes.

Targeted therapies for soft-tissue sarcomas.