FHD-286 for Small Cell Lung Cancer

Overseen By Jacob Sands

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: CYP3A inhibitors, CYP3A inducers, PPIs, Steroids

Disqualifiers: Brain metastases, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: Variable, event-driven

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

Jacob Sands

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

Positive >50% POU2F3 expression by IHC staining

Participants must agree to refrain from donating sperm/ova

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I have been treated with a SMARCA2/4 inhibitor before.

Planning to become pregnant within 1 year after start of study treatment

Timing requirements with respect to prior therapy and surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive FHD-286 orally once daily in 21-day cycles. Possible dose escalation or adjustment based on tolerability.

Variable, event-driven

Visits on days 1, 8, and 15 during cycle 1 and day 1 of every cycle thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment discontinuation

30 days post-treatment

1 visit (in-person)

Long-term follow-up

Annual follow-up for up to 5 years to monitor disease progression and survival

Up to 5 years

Every 8 weeks until disease progression

What Are the Treatments Tested in This Trial?

Interventions

• FHD-286

How Is the Trial Designed?

Group I: FHD-286 Experimental Treatment 1 Intervention

* 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Foghorn Therapeutics Inc.

Industry Sponsor

Trials

3

Recruited

280+