FHD-286 in Subjects With Metastatic Uveal Melanoma

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04879017
Study type	Interventional
Source	Foghorn Therapeutics Inc.
Contact
Status	Terminated
Phase	Phase 1
Start date	May 11, 2021
Completion date	November 30, 2023

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See also
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