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FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies

Refractory Acute Myeloid Leukemia Clinical Trial

Official title:
A Phase 1, Multicenter, Open-Label, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286, as Monotherapy or Combination Therapy, in Subjects With Advanced Hematologic Malignancies

Clinical Trial Summary

This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies.

Clinical Trial Description

This study is primarily intended to evaluate the safety and tolerability of FHD-286 when administered orally as monotherapy or in combination with either LDAC or decitabine to subjects with R/R AML, R/R MDS, and R/R CMML not in blast crisis. In each arm of the study, successive cohorts of participants will receive increasing oral doses of FHD-286 as a single agent or in combination with LDAC or decitabine to determine the RP2D(s) in this population. The data from this study in subjects with advanced hematologic malignancies, 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 NCT04891757
Study type Interventional
Source Foghorn Therapeutics Inc.
Contact Foghorn Clinical Trials
Phone 1-888-615-1298
Email clinicaltrials@foghorntx.com
Status Recruiting
Phase Phase 1
Start date June 14, 2021
Completion date June 2027
View Details
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