FHD-286 in Subjects With Metastatic Uveal Melanoma
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ClinicalTrials.gov Identifier: NCT04879017 |
Recruitment Status :
Terminated
(Sponsor terminated the study for business reasons.)
First Posted : May 10, 2021
Last Update Posted : April 25, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | April 28, 2021 | ||||
First Posted Date ICMJE | May 10, 2021 | ||||
Last Update Posted Date | April 25, 2024 | ||||
Actual Study Start Date ICMJE | May 11, 2021 | ||||
Actual Primary Completion Date | November 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | FHD-286 in Subjects With Metastatic Uveal Melanoma | ||||
Official Title ICMJE | A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects With Metastatic Uveal Melanoma | ||||
Brief 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). | ||||
Detailed 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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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Open label single arm dose escalation and two-arm expansion study in patients with metastatic UM Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Uveal Melanoma | ||||
Intervention ICMJE | Drug: FHD-286
FHD-286 as a single agent
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Study Arms ICMJE | Experimental: FHD-286 dose escalation and expansion
Up to approximately 125 patients will be enrolled in dose escalation and expansion
Intervention: Drug: FHD-286
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
76 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | November 30, 2023 | ||||
Actual Primary Completion Date | November 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Note: A malignant lymph node must be ≥ 15 mm on the short axis when assessed by CT scan to be considered pathologically enlarged and measurable.
Key Exclusion Criteria:
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.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France, Netherlands, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04879017 | ||||
Other Study ID Numbers ICMJE | FHD-286-C-001 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Foghorn Therapeutics Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Foghorn Therapeutics Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Foghorn Therapeutics Inc. | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |