Melanoma Clinical Trial

FHD-286 in Subjects With Metastatic Uveal Melanoma

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-286 oral monotherapy in subjects with metastatic Uveal Melanoma (UM).

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Full 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-286 when administered orally to subjects with metastatic UM. The Dose Escalation Phase will allow for the determination of the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) in subjects with metastatic UM. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-286.

The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-286, including less frequent toxicities and an assessment of antitumor activity. The data from this study in subjects with metastatic UM, including safety, tolerability, PK/PD findings, and antitumor activity, will form the basis for subsequent clinical development of FHD-286.

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Eligibility Criteria

Key Inclusion Criteria:

Male or female subjects ≥ 18 years of age

Subject must have a diagnosis of metastatic histologically or cytologically confirmed UM. If histologic or cytologic confirmation of the primary tumor is not available, clinical confirmation of a diagnosis of metastatic UM, as per standard practice for UM, by the treating investigator can be obtained, and fall into any of the following categories:

Newly diagnosed subject who has not yet received liver-directed or systemic treatment
Subjects ineligible for any available therapy likely to convey clinical benefit
Subjects who have disease progression after treatment with available therapies and/or who is intolerant to those treatments.
Subjects 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 (including liver-directed radio- or immune-therapies) or radiation nor can any local treatment or radiation involving measurable lesions be anticipated.
Willingness to provide newly obtained tumor tissue at baseline and on treatment unless contraindicated by medical risk in the opinion of the treating physician
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2. a.) Arm 2 (Dose Expansion Phase): Subjects enrolling in Arm 2 must have an ECOG PS of ≤ 3.

Key Exclusion Criteria:

Subjects who have other malignancy which may interfere with the diagnosis and/or treatment of metastatic UM.
Subject has thrombocytopenia (platelets < 50 × 109/L) or another major bleeding disorder/diathesis.

Note: Subjects with platelets < 50 × 109/L may be permitted to enroll only in Arm 2 of the Dose Expansion Phase at the discretion of the Investigator and the Sponsor.

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 on corticosteroids so long as the dose is stable for approximately 14 days 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 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 the Sponsor.

Dose Escalation Phase: Subjects with known CNS metastases that meet the above conditions are permitted to enroll in dose escalation.
Arm 1 (Dose Expansion Phase): Subjects with known or suspected CNS metastases are excluded from Arm 1.
Arm 2 (Dose Expansion Phase): Subjects with CNS metastases that meet the above conditions are permitted to enroll in Arm 2.
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 greater than or equal to 350 cells/µL will be permitted, as will subjects who have not had an AIDS-related illness within the past 12 months
Subjects with an active infection cannot be enrolled until any required antibiotic and/or antifungal therapy has been completed and/or infection is determined to be controlled
Subjects who have an uncontrolled intercurrent illness.
Known and possible risk for QT prolongation.
Subject is on medications that are strong CYP3A inhibitors, are strong CYP3A inducers, or are sensitive CYP3A substrates with narrow TIs
Subject is on medications with narrow TIs that are sensitive P-gp or BCRP substrates and are administered orally such as digoxin
Subjects who require clinically significant or increasing doses of systemic steroid therapy or any other systemic immunosuppressive medication. The use of a stable dose of systemic steroids and/or immunosuppressive medication is permitted with Sponsor approval. Local or targeted steroid and immunosuppressive therapies (e.g. inhaled or topical steroids) are acceptable. Appropriate steroid replacement to manage endocrine toxicities resulting from prior systemic anticancer therapy is permitted.
Subjects have undergone any prior treatment with a BRG1/BRM inhibitor.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04879017

Recruitment Status:

Recruiting

Sponsor:

Foghorn Therapeutics Inc.

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There are 9 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States More Info
Inder Mehmi, MD
Contact
University of Miami Health System, Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States More Info
Leonel F Hernandez-Aya, MD
Contact
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Kamaneh Montazeri, MD
Contact
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Elizabeth Buchbinder, MD
Contact
Columbia University, Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Richard Carvajal, MD
Contact
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Alexander Shoushtari, MD
Contact
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia Pennsylvania, 19107, United States More Info
Marlana Orloff, MD
Contact
Sarah Cannon Research Institute
Nashville Tennessee, 37205, United States More Info
Meredith McKean, MD
Contact
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Sapna Patel, MD
Contact
Institute Curie Hospital
Paris , , France More Info
Sophie Piperno-Neumann, MD
Contact
Leiden University Medical Center
Leiden , , Netherlands More Info
Ellen Kapitejin, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT04879017

Recruitment Status:

Recruiting

Sponsor:


Foghorn Therapeutics Inc.

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