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Protocol # 21-250

Status

Active, not recruiting

Description

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 oral monotherapy in subjects with advanced hematologic malignancies, specifically relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R myelodysplastic syndromes (MDS).

Condition

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

Interventions

  • FHD-286

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of treatment-emergent adverse events (TEAEs)
  • Incidence of adverse events (AEs), serious adverse events (SAEs) including changes in safety laboratory parameters and AEs leading to discontinuation
  • Incidence of dose limiting toxicities (DLTs) during cycle 1 (28 days)

Secondary Outcome:

  • AML: Complete remission (CR) rate
  • AML: Duration of CR
  • AML: CR + CR with partial hematologic recovery (CRh) rate
  • AML: Duration of CR + CRh
  • AML: Transfusion independence rate
  • AML: Event free survival (EFS)
  • AML: Overall survival (OS)
  • MDS: CR rate
  • MDS: Duration of CR
  • MDS: Partial remission (PR) rate
  • MDS: Duration of PR
  • MDS: CR + PR
  • MDS: Duration of CR + PR
  • MDS: Hematologic Improvement (HI) rate
  • MDS: EFS
  • MDS: OS
  • PK parameter: Area under the plasma concentration time curve (AUC)
  • Plasma concentration vs. time profiles

Enrollment

50

Study Start Date

June 14, 2021

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Foghorn Therapeutics Inc.

Source

Foghorn Therapeutics Inc.

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 in Subjects With Advanced Hematologic Malignancies

Clinicaltrials.gov Identifier

NCT04891757

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.