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FHD-286

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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 -Non-Small Cell Lung Cancer 387 trials (matched to "Small Cell Lung Cancer")

Frequently asked questions about FHD-286

What is FHD-286 used for?

FHD-286 is an investigational small molecule being studied for the treatment of advanced hematologic malignancies, including relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia, as well as POU2F3-positive small cell lung cancer. It is currently in clinical development and is not yet approved by the FDA.

What does FHD-286 target?

FHD-286 is a SMARCA4/2 inhibitor, meaning it targets the SMARCA4 and SMARCA2 proteins, which are part of the SWI/SNF chromatin remodeling complex. By inhibiting these targets, FHD-286 aims to disrupt 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 to evaluate the drug's safety and efficacy in patients with advanced cancers.

What phase is FHD-286 in?

FHD-286 is in Phase 1 clinical development for advanced hematologic malignancies, with an active trial (NCT04891757) that is not yet recruiting participants. A separate Phase 2 trial (NCT07551635) for small cell lung cancer has been planned but has not yet started recruiting.

What clinical trials is FHD-286 in?

FHD-286 is being studied in two clinical trials. NCT04891757 is a Phase 1 trial evaluating FHD-286 as monotherapy or combination therapy in patients with advanced hematologic malignancies, with an enrollment of 144 participants. NCT07551635 is a Phase 2 trial for POU2F3-positive small cell lung cancer, with an enrollment of 20 participants.

Is FHD-286 the same as a SMARCA4/2 inhibitor?

Yes, FHD-286 is a SMARCA4/2 inhibitor. It is designed to inhibit the SMARCA4 and SMARCA2 proteins, which are involved in chromatin remodeling. This mechanism is being investigated for its potential to treat certain cancers, including hematologic malignancies and small cell lung cancer.