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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 54 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 months for reporting.

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 more

Trial 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

FHD-286 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04879017 — Phase 1
Uveal Melanoma Research Study Groups: FHD-286 dose escalation and expansion
Uveal Melanoma Clinical Trial 2023: FHD-286 Highlights & Side Effects. Trial Name: NCT04879017 — Phase 1
FHD-286 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879017 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people still join this research project?

"Indeed, according to clinicaltrials.gov's records, this trial is still enrolling patients. It was first published on May 17th 2021 and the most recent changes occurred on July 29th 2022. The research team must recruit 100 participants from nine different locations."

Answered by AI

What is the cohort size of this research endeavor?

"Affirmative. Clinicaltrials.gov states that this research began recruiting on the 17th of May 2021 and the details were last modified on July 29, 2022. The experiment requires 100 people to be sourced from 9 clinical sites."

Answered by AI

Has the government organization accepted FHD-286 for public use?

"Due to the limited data available in Phase 1 trials, FHD-286 attained a score of 1 on our risk assessment scale."

Answered by AI

Is this experimental therapy available in multiple healthcare facilities within the U.S.?

"Nine different medical centres are participating in this trial, such as The Angeles Clinic and Research Institute based in Los Angeles, MD Anderson Cancer Center situated in Houston, and Memorial Sloan Kettering Cancer Centre located near New york."

Answered by AI

What does this clinical experiment aim to achieve?

"Foghorn Therapeutics Inc. are the sponsors of this trial, and their primary objective is to evaluate the occurrence rate of negative reactions (including SAEs) as well as changes in safety laboratory parameters over a 28 day cycle. Supplementary outcomes being evaluated include plasma concentration versus time profiles, overall survival from first dose until death due to any cause, and duration of response - that is, time between initial confirmation of either complete or partial remission until earliest date of documented progression or mortality due to any factor among responders who achieved CR/PR."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FHD-286 in Subjects With Metastatic Uveal Melanoma
2021. "FHD-286 in Subjects With Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04879017.
~19 spots leftby May 2025
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