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FHD-286 With Low-Dose Weekly Decitabine/Venetoclax in Patients With Acute Myeloid Leukemia

NCT07283094 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-03-03

No results posted yet for this study

Summary

This is a Phase 1, uncontrolled, single-arm, open-label, nonrandomized, dose escalation, study of Decitabine (DAC)+Venetoclax (VEN)+FHD-286 in participants with newly diagnosed Acute Myeloid Leukemia (AML) classified as adverse risk per the 2022 European Leukemia Net (ELN) criteria or AML that has progressed after one prior line of therapy.

Conditions

Interventions

DRUG

Decitabine

Decitabine: 0.2 mg/kg/day subcutaneously once weekly (QW) (days 1, 8, 15, 22 \[±3 days\] of each 28-day cycle) \- A second weekly dose may be added if the investigator determines that more rapid debulking is required for a participant with high disease burden. The 2 weekly DAC doses should, preferably, be given on consecutive days

DRUG

Venetoclax

Venetoclax: 400 mg orally (PO) (tablets) QW, concurrent with the first weekly DAC dose (days 1, 8, 15, and 22 \[±1 day\] of each 28-day cycle) * Refer to the United States Prescribing Information (USPI) ("steady daily dose") for details regarding VEN dosage modifications. When decitabine is held, venetoclax should also be held. Based on best clinical judgment, the investigator may continue decitabine while withholding VEN for several doses to allow for improved count recovery * If treatment with a P-gp inhibitor or triazole antifungal agent classified as a moderate CYP3A inhibitor is medically necessary, reduce the VEN dose by at least 50% * If treatment with posaconazole is medically necessary, reduce the VEN dose to 70 mg * If treatment with another triazole antifungal agent classified as a strong CYP3A inhibitor is medically necessary, reduce the VEN dose to 100 mg

DRUG

FHD-286

FHD-286: 2.5 or 5 mg (based on assigned dose group) PO (capsules) once daily (QD) 5 days/week (days 3-7, 10-14, 17-21, and 24-28 of each 28-day cycle) If acceptable safety and tolerability are observed at the end of cycle 1 with at least 3 DLT-evaluable participants in cohort 1 (FHD-286 2.5 mg QD), the dose of FHD-286 will be escalated to 5 mg QD for cohort 2. Doses of DAC and VEN will not change The 2 non-dosing days must be the day of and the day after the VEN dose * If necessary to improve tolerability and/or reduce toxicity, frequency of FHD-286 dosage may be reduced to 4 days/week * FHD-286 dose level will be escalated/de-escalated as described in protocol * If treatment with a strong CYP3A inhibitor is medically necessary, discussion with the PI is required and the FHD-286 dose should be reduced to 1.5 mg QD. Dose interruption or discontinuation of FHD-286 may also be necessary * See protocol for information on prohibited concomitant therapies when medically necessary

Sponsors & Collaborators

  • Foghorn Therapeutics Inc.

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Mendel R Goldfinger, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-03
Primary Completion
2028-05-31
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT07283094 on ClinicalTrials.gov