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FHD-286 for Uveal Melanoma
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
Subject must have a diagnosis of metastatic histologically or cytologically confirmed UM
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 54 months
Awards & highlights
Study Summary
This trial is designed to assess the safety and preliminary clinical activity of FHD-286, an oral drug, in people with metastatic uveal melanoma.
Who is the study for?
This trial is for adults over 18 with metastatic Uveal Melanoma. Participants must have measurable disease, provide tumor tissue samples, and have an ECOG performance status of ≤2 or ≤3 depending on the study phase. Exclusions include other cancers, major bleeding disorders, brain metastases, uncontrolled illnesses, active infections requiring treatment, immunosuppressive medication use (including steroids), prior BRG1/BRM inhibitor treatment, certain viral infections like HBV/HCV or HIV/AIDS-related illness.Check my eligibility
What is being tested?
The trial tests FHD-286 oral monotherapy in patients with metastatic Uveal Melanoma to evaluate its safety and effectiveness. It's a Phase 1 study involving dose escalation and expansion phases to understand how the drug behaves in the body (pharmacokinetics) and affects cancer cells (pharmacodynamics).See study design
What are the potential side effects?
While specific side effects are not listed here for FHD-286 as it's still under investigation in this early-phase trial; common side effects from similar treatments may include nausea, fatigue, liver toxicity risks among others which will be closely monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with metastatic uveal melanoma.
Select...
I have a tumor that can be measured and is at least 10 mm in size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 54 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 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) during cycle 1 (28 days)
Incidence of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Duration of Response (DOR)
Objective Response Rate (ORR)
Overall Survival (OS)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FHD-286 dose escalation and expansionExperimental Treatment1 Intervention
Up to approximately 125 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
199 Total Patients Enrolled
Sarah Reilly, MDStudy DirectorFoghorn Therapeutics
2 Previous Clinical Trials
199 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have low platelets or a serious bleeding disorder.I am 18 years old or older.I have active brain tumors or cancer in the lining of my brain.I can care for myself but may not be able to do heavy physical work.I have a serious illness that is not under control.I do not have an active infection or it is under control.I need or am taking higher doses of steroids or other drugs that weaken my immune system.I have been diagnosed with metastatic uveal melanoma.I am taking medication like digoxin that is sensitive to certain body processes.I have never been treated with a BRG1/BRM inhibitor.I do not have any other cancer that could affect my metastatic UM treatment.I have an active hepatitis B or C infection.I am HIV positive or have an AIDS-related illness.I have a tumor that can be measured and is at least 10 mm in size.I am taking medication that strongly affects liver enzyme activity.I am at risk for abnormal heart rhythms.
Research Study Groups:
This trial has the following groups:- Group 1: FHD-286 dose escalation and expansion
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.
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