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

NCT04891757 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-07-10

No results posted yet for this study

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.

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

DRUG

FHD-286

FHD-286 administered orally

DRUG

Low Dose Cytarabine

LDAC administered subcutaneously (SC)

DRUG

Decitabine

Decitabine administered intravenously

Sponsors & Collaborators

  • Foghorn Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Reilly, MD · Foghorn Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2025-09-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891757 on ClinicalTrials.gov