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FHD-286 for Blood Cancers

Phase 1
Recruiting
Research Sponsored by Foghorn Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects must be postmenopausal, permanently sterile, or nonpregnant and nonlactating
Subject must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up 42 months
Awards & highlights

Study Summary

This trial tests a new drug to treat advanced blood cancers, like AML & MDS, to see how safe & effective it is.

Who is the study for?
Adults with advanced blood cancers like myelodysplastic syndrome or acute myeloid leukemia can join this trial. They must be able to consent, follow the study plan, and have a life expectancy of at least 3 months. Key organ functions need to be stable, and they should not consume certain foods or supplements that affect specific enzymes. Women must not be pregnant or breastfeeding, and men agree to use contraception.Check my eligibility
What is being tested?
The trial is testing FHD-286 alone or with other drugs (Low Dose Cytarabine/Decitabine) in patients with serious blood disorders. It's an early-phase study looking at safety, how well the body handles the drug (PK/PD), and its initial effectiveness against cancer.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones for cancer treatments include nausea, fatigue, liver issues (hepatic function), kidney problems (renal function), bleeding due to low platelets level, heart complications (cardiovascular issues), breathing difficulties (respiratory function), and weakened immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who is either postmenopausal, cannot have children, or am not pregnant and not breastfeeding.
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I am 18 years old or older.
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I have been diagnosed with an advanced blood cancer.
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I can take care of myself and am up and about more than half of my waking hours.
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My liver is functioning well.
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I am a man who either had a vasectomy or will use effective birth control if sexually active.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), AEs leading to discontinuation, and adverse events of special interest (AESIs); safety laboratory assessments
Secondary outcome measures
AML: CR + CR with partial hematologic recovery (CRh) rate
AML: Complete remission (CR) rate
AML: Duration of CR
+15 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: FHD-286 in Combination with LDACExperimental Treatment2 Interventions
FHD-286 administered orally + LDAC administered subcutaneously
Group II: FHD-286 in Combination with DecitabineExperimental Treatment2 Interventions
FHD-286 administered orally + decitabine administered intravenously (IV)
Group III: FHD-286 MonotherapyExperimental Treatment1 Intervention
Closed to Enrollment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2004
Completed Phase 3
~1680
Low Dose Cytarabine
2012
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

Foghorn Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
131 Total Patients Enrolled
Sarah Reilly, MDStudy DirectorFoghorn Therapeutics
2 Previous Clinical Trials
131 Total Patients Enrolled

Media Library

FHD-286 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04891757 — Phase 1
Myelodysplastic Syndromes Research Study Groups: FHD-286 Monotherapy, FHD-286 in Combination with LDAC, FHD-286 in Combination with Decitabine
Myelodysplastic Syndromes Clinical Trial 2023: FHD-286 Highlights & Side Effects. Trial Name: NCT04891757 — Phase 1
FHD-286 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891757 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies
2021. "FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04891757.
~46 spots leftby Sep 2025
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