What side effects are associated with this type of intervention?

Common treatments for Uveal Melanoma, particularly those involving systemic chemotherapy, often have ocular side effects. These can include dry eye, blurred vision, conjunctivitis, keratitis, and periorbital edema. Specific agents like methotrexate can cause optic neuropathy and visual field defects, while drugs like pemetrexed may lead to eyelid edema and conjunctivitis. Other treatments, such as enfortumab vedotin and tisotumab vedotin, have been associated with a range of eye disorders including keratopathy, corneal erosions, and increased lacrimation. Management of these side effects typically involves the use of artificial tears, topical corticosteroids, and dose adjustments.

What prior FDA approvals exist?

Historically, the FDA has approved several treatments for Uveal Melanoma, including immunotherapies and targeted therapies. Notable drugs include pembrolizumab and ipilimumab, which are immune checkpoint inhibitors, and selumetinib, a MEK inhibitor. These treatments aim to enhance the body's immune response against cancer cells or target specific pathways involved in tumor growth. While the exact mechanism of FHD-286 is not specified, it is likely being studied for its potential to offer a novel approach in treating metastatic Uveal Melanoma.

What other types of research exist?

Promising alternatives to FHD-286 for Uveal Melanoma patients include combination therapies involving VEGF inhibitors like ranibizumab and PDGF inhibitors such as E10030. These have shown preliminary safety and potential efficacy in treating ocular neovascular conditions. Additionally, ongoing research into anti-VEGF fusion proteins like conbercept may offer new therapeutic options.

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FHD-286 for Uveal Melanoma

Q: What is the mechanism of action of this treatment?

Common treatments for Uveal Melanoma include traditional chemotherapy agents, targeted therapies, and investigational drugs. Traditional chemotherapy, such as taxanes and platinum analogs, works by disrupting cell division, leading to cancer cell death. Targeted therapies, like those inhibiting angiogenesis or specific molecular pathways, aim to block the growth signals of cancer cells. Investigational drugs like FHD-286, although not specified, likely target specific molecular mechanisms involved in Uveal Melanoma progression. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment, managing side effects, and improving overall outcomes.

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

Must not have

Subject has thrombocytopenia (platelets < 50 × 10^9/L) or another major bleeding disorder/diathesis

Subject has active brain metastases and/or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral medicine called FHD-286 in patients with metastatic Uveal Melanoma. It aims to find the safest and most effective dose while checking if it can help shrink the tumors.

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.

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).

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

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I have been diagnosed with metastatic uveal melanoma.

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I have a tumor that can be measured and is at least 10 mm in size.

Exclusion Criteria

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

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I have low platelets or a serious bleeding disorder.

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I have active brain tumors or cancer in the lining of my brain.

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I have a serious illness that is not under control.

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I need or am taking higher doses of steroids or other drugs that weaken my immune system.

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I am taking medication like digoxin that is sensitive to certain body processes.

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I have never been treated with a BRG1/BRM inhibitor.

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I do not have any other cancer that could affect my metastatic UM treatment.

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I have an active hepatitis B or C infection.

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I am HIV positive or have an AIDS-related illness.

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I am taking medication that strongly affects liver enzyme activity.

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I am at risk for abnormal heart rhythms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 months

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

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) during cycle 1 (28 days)

Incidence of treatment-emergent adverse events (TEAEs)

Secondary study objectives

Duration of Response (DOR)

Objective Response Rate (ORR)

Overall Survival (OS)

+5 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-286 dose escalation and expansionExperimental Treatment1 Intervention

Up to approximately 125 patients will be enrolled in dose escalation and expansion

0 / 13Eligibility 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

Common treatments for Uveal Melanoma include traditional chemotherapy agents, targeted therapies, and investigational drugs. Traditional chemotherapy, such as taxanes and platinum analogs, works by disrupting cell division, leading to cancer cell death. Targeted therapies, like those inhibiting angiogenesis or specific molecular pathways, aim to block the growth signals of cancer cells. Investigational drugs like FHD-286, although not specified, likely target specific molecular mechanisms involved in Uveal Melanoma progression. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment, managing side effects, and improving overall outcomes.

Tumor regression after photocoagulation of malignant melanomas of the choroid: an ultrasonographic study.[Exudative age-related macular degeneration: efficacy and limits of the different treatments].