SMARCA4/2 Inhibitor for POU2F3-Positive SCLC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07551635
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FHD-286 — DRUG
    SMARCA4/2 inhibitor, capsule, taken orally per protocol

Study Details

This is a single-arm, phase II clinical trial evaluating the efficacy and safety of FHD-286, a SMARCA4/2 inhibitor, in participants with POU2F3-expressing small cell lung cancer who have received at least one prior line of platinum-based therapy. All participants will receive FHD-286 orally once daily in 21-day cycles. The primary objective is to assess the objective response rate of FHD-286 in this population. The names of the study drug involved in this study is: • FHD-286 (a small-molecule SMARCA4/2 ATPase (BRG1 and BRM) inhibitor targeting the SWI/SNF chromatin remodeling complex (also known as the BAF complex)

Key Dates

Start date
Sep 4, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FHD-286
    * 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.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jacob Sands
[email protected]
617-632-6049
Jacob Sands (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
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By research site
Dana-Farber Cancer Institute· Boston, MA

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