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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 Cancer
NCT0755163520
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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 395 trials (matched to "Small Cell Lung Cancer")

Top 20 of 86 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel
Bristol-Myers Squibb CompanyBMY19PHASE3Repotrectinib, Crizotinib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Pfizer Inc.PFE17PHASE3Lorlatinib, Crizotinib
GSK plc Sponsored ADRGSK4PHASE3Dostarlimab, Belrestotug, Pembrolizumab
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
BeyondSpring Inc.BYSI1PHASE3Plinabulin, Docetaxel
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07551635primaryCompletionDate: changed
LOWMay 26, 2026NCT04891757primaryCompletionDate: changed
LOWMay 24, 2026NCT07551635studyFirstPostDate: changed
LOWMay 24, 2026NCT04891757studyFirstPostDate: changed
LOWMay 21, 2026NCT07551635NEW_TRIAL: changed
LOWMay 21, 2026NCT07551635NEW_TRIAL: changed