FHD-286 for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new oral treatment called FHD-286 for individuals with small cell lung cancer that has spread, particularly in those whose cancer cells express a specific marker called POU2F3. The goal is to evaluate the medication's effectiveness and safety for patients who have already undergone at least one type of platinum-based chemotherapy. Participants will take the drug daily in 21-day cycles, and researchers will monitor their responses. Suitable candidates have experienced cancer recurrence or progression after previous treatment and have cancer cells expressing the POU2F3 marker. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
You may need to stop taking certain medications before joining the trial. Specifically, you must stop strong CYP3A inhibitors at least 1 week before starting the study drug and strong CYP3A inducers at least 2 weeks before. Proton pump inhibitors should also be stopped or switched 7 days before the trial, unless approved by the investigator.
Is there any evidence suggesting that FHD-286 is likely to be safe for humans?
A previous study found FHD-286 to be safe and well-tolerated by patients. The research showed that participants could take daily doses of up to 7.5 mg without significant issues. Although the study focused on other types of cancer, the results offer a good understanding of its safety. Participants reported no major side effects at this dosage, indicating that FHD-286 is generally well-tolerated. This suggests the treatment might be safe for those considering joining this trial.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about FHD-286 for small cell lung cancer because it offers a novel approach compared to the existing chemotherapy and immunotherapy options. Unlike these standard treatments, FHD-286 works by targeting specific epigenetic factors, which are responsible for turning genes on or off in cancer cells. This unique mechanism of action has the potential to disrupt cancer cell growth more precisely, with possibly fewer side effects. Additionally, FHD-286 is taken once daily, allowing for a simpler dosing regimen that could improve patient compliance.
What evidence suggests that FHD-286 might be an effective treatment for small cell lung cancer?
Research has shown that FHD-286 offers promising results for treating certain cancers. Studies have found that FHD-286 blocks the activity of proteins called BRG1 and BRM, which aid cancer cell growth. In early animal tests, FHD-286 demonstrated strong anti-cancer effects, particularly in lung and prostate cancer. It also appears to transform cancer cells into less harmful types. Although more research is needed to confirm these effects in humans, this trial will evaluate FHD-286 as a potential effective treatment for small cell lung cancer.16789
Who Is on the Research Team?
Jacob Sands
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with extensive stage small cell lung cancer that tests positive for POU2F3 and has come back or worsened after at least one round of platinum-based treatment. Participants must be in good general health, able to swallow pills, not pregnant or breastfeeding, and meet specific organ function requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive FHD-286 orally once daily in 21-day cycles. Possible dose escalation or adjustment based on tolerability.
Follow-up
Participants are monitored for safety and effectiveness after treatment discontinuation
Long-term follow-up
Annual follow-up for up to 5 years to monitor disease progression and survival
What Are the Treatments Tested in This Trial?
Interventions
- FHD-286
Trial Overview
The study is testing FHD-286, a new oral drug taken daily in cycles, to see how well it works and how safe it is for people with this type of lung cancer. All participants receive the same treatment; there is no comparison group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
* 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Foghorn Therapeutics Inc.
Industry Sponsor
Citations
SMARCA4/2 Inhibitor for POU2F3-Positive SCLC
This is a single-arm, phase II clinical trial evaluating the efficacy and safety of FHD-286, a SMARCA4/2 inhibitor, in participants with ...
2.
aacrjournals.org
aacrjournals.org/clincancerres/article/31/12/2327/762768/A-Phase-I-Study-of-FHD-286-a-Dual-BRG1-BRM-SMARCA4A Phase I Study of FHD-286, a Dual BRG1/BRM (SMARCA4 ...
The mechanism of action of FHD-286 includes promotion of differentiation of leukemic cells, which carries a risk of clinical differentiation ...
Superior preclinical efficacy of co-treatment with BRG1/BRM ...
Co-treatment with FHD-286 and FLT3i exerts superior pre-clinical efficacy against AML cells and patient-derived (PD) xenograft (PDX) models of AML with FLT3 ...
October 4, 2023
FHD-286 is a highly potent, selective, allosteric, and orally available, small-molecule, enzymatic inhibitor of BRG1 (SMARCA4) and BRM (SMARCA2) ...
Mammalian SWI/SNF complex activity regulates POU2F3 ...
Further, expression of genes that were specifically downregulated by FHD-286 in non-NE cell lines was higher in the NE-like cell lines (COR-L311 ...
SMARCA4 controls state plasticity in small cell lung cancer ...
Based on its potent pre-clinical activity against cancer cells including leukemia and lung adenocarcinoma cells, FHD286 is currently being ...
establishing the cellular and molecular impacts of the dual ...
D) The lung basal cell gene expression signature decreased over time in response to FHD-286 in both NSCLC CDX tumor models. Conclusions. ❑ NSCLC models respond ...
A Phase 2 Study of SMARCA4/2 inhibitor (FHD-286) for ...
A Phase 2 Study of SMARCA4/2 inhibitor (FHD-286) for POU2F3-Positive Small-Cell Lung Cancer. NOT ENROLLING. 877-DF-TRIAL (877-338-7425). Protocol # :.
9.
targetedonc.com
targetedonc.com/view/fda-lifts-partial-clinical-hold-on-study-of-fhd-286-in-r-r-aml-mdsFDA Lifts Partial Clinical Hold on Study of FHD-286 in R/R ...
Investigators believe that the combination of FHD-286 with decitabine or cytarabine may mitigate the risk for differentiation syndrome given the ...
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