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Small Cell Lung CancerPhase 2NCT07551635

SMARCA4/2 Inhibitor for POU2F3-Positive SCLC

A Phase 2 study testing FHD-286 in people with Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
FHD-286
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
28 Apr 2026to 31 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alissa Cooper contact

617-632-6049

alissa_cooper@dfci.harvard.edu

Alissa Cooper contact

alissa_cooper@dfci.harvard.edu

United States1 site, 1 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Alissa Cooper, 617-632-6049, alissa_cooper@dfci.harvard.edu

    Alissa Cooper

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2 Study of SMARCA4/2 Inhibitor (FHD-286) for POU2F3-Positive Small-Cell Lung Cancer

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)
Read the detailed description

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 following tools: Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission Tomography (PET) scans, blood tests, pregnancy test for women of childbearing potential, Electrocardiogram (ECG), Echocardiogram (ECHO) test, tumor tissue sample, and biobanking.

It is expected that about 20 people will take part in this research study.

Foghorn Therapeutics, Inc. is supporting this research study by providing study drug and partial funding. 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.

It is expected that about 20 people will take part in this research study Foghorn Therapeutics, Inc. is supporting this research study by providing study drug and partial funding.

Being tested
FHD-286
Keywords
POU2F3-Positive Small Cell Lung Cancer, Small Cell Lung Cancer
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FHD-286Drug

    SMARCA4/2 inhibitor, capsule, taken orally per protocol

Study groups in NCT07551635
Study groupRoleWhat they receive
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.
Receives: Drug: FHD-286

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    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).

    Measured: 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.

Secondary outcomes (5)

  1. Median Progression-Free Survival (PFS)

    PFS is defined as the time from start of treatment to time of disease progression (PD) or death from any cause, whichever occurs first. Participants alive without PD are censored at date of last disease evaluation (regardless of whether non-protocol therapy has been given). Median PFS is estimated based on the Kaplan-Meier method. PD is based on RECIST v1.1 criteria (Eisenhauer et al Eur J Ca 45:228-247, 2009).

    Measured: 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.

  2. Median Overall Survival

    OS is defined as the time from start of treatment until death due to any cause, or censored at the date last known alive. Median OS is estimated based on the Kaplan-Meier method.

    Measured: Survival assessed up to 5 years.

  3. Median Time-To-Progression (TTP)

    TTP is defined as the time from start of treatment to disease progression (PD), or censored at date of last disease evaluation for those without PD reported. Median TTP is estimated based on the Kaplan-Meier method. PD is based on RECIST v1.1 criteria (Eisenhauer et al Eur J Ca 45:228-247, 2009).

    Measured: 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.

  4. Median Duration of Response (DOR)

    DOR is defined as the time from the documented objective response (partial or complete response) until disease progression (PD) or death, or censored at the time of their last disease evaluation. Median DOR is estimated based on the Kaplan-Meier method. Response and PD are based on RECIST v1.1 criteria (Eisenhauer et al Eur J Ca 45:228-247, 2009).

    Measured: 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.

  5. Treatment-Related Grade 3-4 Adverse Event (AE) Rate

    Percentage of participants who experience an AE of grade 3 or 4 with treatment attribution of possible, probable or definite per Common Toxicity Adverse Event Criteria (CTCAE) version 5 on treatment.

    Measured: Observed on treatment plus 30 days; Time frame is variable by patient as duration of treatment is event-driven per protocol section 5.5. AEs assessed on treatment days 1, 8, and 15 during cycle 1 and day 1 of every cycle thereafter (cycle duration=21 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2026
  2. Study start28 Apr 2026
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07551635
Sponsor's protocol ID
25-859
Status last verified
Oct 2026
First submitted
20 Apr 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FHD-286 in people with Small Cell Lung Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alissa Cooper (617-632-6049, alissa_cooper@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07551635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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