Dana-Farber Cancer Institute
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)
This is a single-arm, phase II clinical trial evaluating the efficacy and safety of FHD-286, a SMARCA4/2 inhibitor, in participants with extensive-stage small cell lung cancer and documented POU2F3 expression, who have progressed after prior platinum-based therapy. FHD-286 has not been approved by the FDA or any other regulatory authorities around the world for the treatment of POU2F3 expressing small cell lung cancer. The study includes clinical examinations, medical history collection, performance status evaluation, vital signs and weight checks, tumor assessments by one or more of the fol…
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% POU2F3 expression by IHC staining. * Participants must have measurable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or l. * Participants must meet the following organ and marrow function criteria: * leukocytes ≥2,000/mcL * absolute neutrophi…
SMARCA4/2 inhibitor, capsule, taken orally per protocol
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