NCT04891757

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Foghorn Therapeutics Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Hematologic Malignancy
• Relapsed Acute Myeloid Leukemia
• Refractory Acute Myeloid Leukemia
• Relapsed Myelodysplastic Syndromes
• Refractory Myelodysplastic Syndromes
• Relapsed Chronic Myelomonocytic Leukemia
• Refractory Chronic Myelomonocytic Leukemia

Interventions

Type	Name	Description
DRUG	FHD-286	FHD-286 administered orally
DRUG	Low Dose Cytarabine	LDAC administered subcutaneously (SC)
DRUG	Decitabine	Decitabine administered intravenously

Timeline

• Start date: 2021-06-14
• Primary completion: 2025-09-01
• Completion: 2027-06-01
• First posted: 2021-05-18
• Last updated: 2025-07-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study