FHD-286 for POU2F3-Positive Small Cell Lung Cancer
This study is testing a drug called FHD-286 for people with small cell lung cancer (SCLC) that has spread (extensive stage) and has a specific marker called POU2F3. You would have already received platinum-based chemotherapy. FHD-286 works by targeting a specific pathway in cancer cells (SMARCA4/2 inhibitor). The main goal is to see how many people respond to the treatment (Objective Response Rate, ORR). About 20 people are expected to join this study. The study status is currently unclear.
- Study design
- This is a single-arm, Phase 2 study, meaning everyone receives the same treatment. About 20 participants are expected to join.
- What's involved
- You would take FHD-286 orally once daily in 21-day cycles. You will have clinical exams, blood tests, imaging scans (CT, MRI, or PET), and possibly an ECG and ECHO test. Tumor assessments are done every 2 cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be followed up to 12 months after the treatment period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07551635
SMARCA4/2 Inhibitor for POU2F3-Positive SCLC
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentDana-Farber Cancer InstituteInvestigator-initiated
~20 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:FHD-286
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over 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.
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Jacob Sands · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 neutrophil count (ANC) ≥1,000/mcL
platelets ≥50,000/mcL
hemoglobin ≥9 g/dL
total bilirubin ≤ 1.5 institutional upper limit of normal (ULN); Unless considered due to advanced malignancy involvement or Gilbert syndrome, with PI approval
AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN; Unless considered due to advanced malignancy involvement, with PI approval
ALP ≤3.0 × institutional ULN; Unless considered due to advanced malignancy involvement, with PI approval
prothrombin time ≤1.5 × institutional ULN or international normalized ratio (INR) ≤1.4
activated partial thromboplastin time (aPTT) ≤1.5 × institutional ULN; PI approval is required for a participant receiving anticoagulation therapy for treatment of a stable medical condition
creatinine ≤ 1.5 institutional ULN OR glomerular filtration rate (GFR) ≥40 mL/min/1.73 m2
left ventricular ejection fraction ≥40% by ECHO
no known portal vein thrombosis
adequate cardiovascular, respiratory, and immune system function, in the opinion of the investigator
Agree to abide by dietary and other considerations required during the study
The effects of FHD-286 on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) sexually active with male partners and fertile men sexually active with WOCBP must agree to use dual contraceptive measures (hormonal or barrier method of birth control; abstinence; condom), beginning at the screening visit and until 90 days after taking the last dose of FHD-286. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Participants must agree to refrain from donating sperm/ova from the screening visit through 90 days after the last dose of FHD-286.
The potential risk to fertility posed by FHD-286 is unknown. It is recommended that subjects discuss options for fertility preservation with their doctor before starting treatment.
See Section 5.2.2 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents.
Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
Note: Non-child-bearing potential is defined as follows:
\>45 years of age and has not had menses for \>1 year. Participants who have been amenorrhoeic for \<2 years without history of a hysterectomy or bilateral oophorectomy must have a follicle-stimulating hormone value in the postmenopausal range upon screening evaluation.
Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
Ability to understand and the willingness to sign a written informed consent document.
Must be willing and able to swallow pills
Exclusion
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
Participants who are receiving any investigational therapy
Symptomatic brain metastases (untreated, asymptomatic brain metastases are eligible if size \<6 mm).
Participants receiving any medications or substances that are strong inhibitors, strong inducers, or sensitive CYP3A substrates (with narrow therapeutic indices) of CYP3A enzymes are ineligible (see also Section 3.3).
Individuals must have stopped treatment with strong CYP3A inhibitors at least 1 week or 5 half-lives, whichever is longer, before the first dose of study drug. Strong CYP3A inhibitors may be permitted with PI approval; the FHD-286 dose should be reduced to 1.5 mg QD when a strong CYP3A inhibitor is in use.
Individuals must have stopped treatment with strong CYP3A inducers at least 2 weeks or 5 half-lives, whichever is longer, before the first dose of study drug. Strong CYP3A inducers may be permitted with PI approval.
Stable doses of immunosuppressants that are sensitive CYP3A substrates with narrow therapeutic indices may be permitted with PI approval.
Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
Taking proton pump inhibitors (PPIs). Administration of PPIs must be stopped or switched to another acid-reducing agent within 7 days before study entry. If it is medically necessary to administer PPIs concomitantly with FHD-286, this may be permitted with PI approval.
Taking clinically significant or increasing doses of systemic steroid therapy or any other systemic immunosuppressive medication. The use of a stable dose of such therapies may be permitted with PI approval. Local/targeted therapies, eg, inhaled or topical steroids, are acceptable. Appropriate steroid replacement to manage endocrine toxicities resulting from prior systemic anticancer therapy is acceptable.
Currently pregnant. Female participants must have a negative urine pregnancy test within 7 days prior to taking study treatment if of childbearing potential.
Currently breastfeeding.
Planning to become pregnant within 1 year after start of study treatment.
Any active cancer requiring systemic treatment or prior cancer treated within past 2 years (excluding non-melanoma skin cancer, DCIS, low risk prostate cancer not requiring treatment, superficial bladder cancer, or other low risk cancers after communication with PI).
Timing requirements with respect to prior therapy and surgery:
Radiotherapy: At least 2 weeks must have elapsed since last radiotherapy
Surgery: Participant must be recovered from any clinically relevant effects of any prior surgery
Any active infection requiring treatment (excluding HIV with undetectable viral load). Active hepatitis B (defined by presence of Hep B sAg) or C is not eligible, unless the individual has a sustained viral response to HCV treatment or immunity to prior HBV infection.
Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study. This includes, but is not limited to:
QTcF \>470 msec or other factors that increase the risk of QTc prolongation. Participants with QTcF \>470 msec and bundle branch block and/or pacemaker rhythm may be enrolled with approval from PI.
New York Heart Association class III/IV congestive heart failure of
Psychiatric illness/social situations that would limit compliance with study requirements
Any other prior or ongoing condition that, in the opinion of the investigator, could adversely affect the safety of the individual or impair the assessment of study results
GI dysfunction that would preclude adequate absorption, distribution, metabolism, or excretion of FHD-286
Known hypersensitivity to any component of the FHD-286 formulation
Prior treatment with any SMARCA2/4 inhibitor, including FHD-286
What this trial measures
- 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).