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FHD-286

Phase 2

Small Cell Lung Cancer | Small molecule | Oncology |Foghorn Therapeutics Inc.|Trials Updated: Apr 27, 2026

FHD-286 development status

Highest phase Phase 2
Registered trials 4 across 3 sponsors since May 2021

FHD-286 target and mechanism

Molecular targetSMARCA2/SMARCA4
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials2
Total Enrollment164

FDA Designations

No designations recorded

FHD-286 clinical trials

FHD-286 · 2 trials · 8 indications

Phase 2 1Phase 1 1
NCT07551635SMARCA4/2 Inhibitor for POU2F3-Positive SCLCSmall Cell Lung Cancer
NOT YET_RECRUITING20 Analytics
PHASE2NOT YET_RECRUITING
SMARCA4/2 Inhibitor for POU2F3-Positive SCLC
Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR)
Observed on treatment; Time frame is variable by patient as duration of treatment is event-driven per protocol section 5.5. Disease assessed on treatment every 2 cycles (cycle duration=21 days). Response follow-up expected up to 12 months.

ORR is the percentage of participants achieving complete or partial response on treatment based on RECIST v1.1 criteria (Eisenhauer et al Eur J Ca 45:228-247, 2009).

Incidence of AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), AEs leading to discontinuation, and adverse events of special interest (AESIs); safety laboratory assessments
Up to 18 months

Secondary Endpoints

Median Progression-Free Survival (PFS)
Disease assessed on treatment every 2 cycles (cycle duration=21 days) and in long-term follow-up every 8 weeks until disease progression. Disease follow-up expected up to 5 years.
Median Overall Survival
Survival assessed up to 5 years.
Median Time-To-Progression (TTP)
Disease assessed on treatment every 2 cycles (cycle duration=21 days) and in long-term follow-up every 8 weeks until disease progression. Disease follow-up expected up to 5 years.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FHD-286EXPERIMENTAL* Baseline visit * Cycle 1 through End of Treatment (21-day cycles) * Days 1 - 21: Predetermined dose of FHD-286 1X daily. Possible dose escalation or based on tolerability. * 30 day follow up post-treatment discontinuation * Annual follow up for up to 5 years.
FHD-286 MonotherapyEXPERIMENTALClosed to Enrollment
FHD-286 in Combination with LDACEXPERIMENTALFHD-286 administered orally + LDAC administered subcutaneously
FHD-286 in Combination with DecitabineEXPERIMENTALFHD-286 administered orally + decitabine administered intravenously (IV)

Interventions

NameTypeDescription
FHD-286DRUGSMARCA4/2 inhibitor, capsule, taken orally per protocol
Low Dose CytarabineDRUGLDAC administered subcutaneously (SC)
DecitabineDRUGDecitabine administered intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult age l8 years or older, who have provided written informed consent. * Histologically or cytologically confirmed extensive stage SCLC with documented disease progression or recurrence after prior platinum-based therapy with or without checkpoint inhibitor. * Positive \>50%...

Countries:United States
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Competitive Landscape -Small Cell Lung Cancer 3 trials

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN1PHASE3Tarlatamab
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Frequently asked questions about FHD-286

What is FHD-286 used for?

FHD-286 is an investigational small molecule being developed for advanced hematologic malignancies and small cell lung cancer. In hematologic malignancies, it is studied in relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia. It is also being evaluated in POU2F3-positive small cell lung cancer.

What does FHD-286 target?

FHD-286 targets SMARCA2 and SMARCA4, which are catalytic subunits of the SWI/SNF chromatin remodeling complex. By inhibiting these targets, FHD-286 aims to disrupt gene expression programs that drive cancer cell growth in certain malignancies.

Who makes FHD-286?

FHD-286 is being developed by Foghorn Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FHTX. The company is conducting clinical trials of FHD-286 in advanced hematologic malignancies and small cell lung cancer.

What phase is FHD-286 in?

FHD-286 is in Phase 1 clinical development. One Phase 1 trial is active but not recruiting patients with advanced hematologic malignancies. A separate Phase 2 trial in small cell lung cancer is not yet recruiting. FHD-286 is investigational and has not been approved by regulatory authorities.

What clinical trials is FHD-286 in?

FHD-286 is being studied in two clinical trials. NCT04891757 is a Phase 1 trial in advanced hematologic malignancies with 144 participants, active but not recruiting. NCT07551635 is a Phase 2 trial in POU2F3-positive small cell lung cancer with 20 participants, not yet recruiting. Both trials are in the United States.