Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FHD-286 · 2 trials · 8 indications
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).
| Arm | Type | Description |
|---|---|---|
| FHD-286 | EXPERIMENTAL | * 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. |
| FHD-286 Monotherapy | EXPERIMENTAL | Closed to Enrollment |
| FHD-286 in Combination with LDAC | EXPERIMENTAL | FHD-286 administered orally + LDAC administered subcutaneously |
| FHD-286 in Combination with Decitabine | EXPERIMENTAL | FHD-286 administered orally + decitabine administered intravenously (IV) |
| Name | Type | Description |
|---|---|---|
| FHD-286 | DRUG | SMARCA4/2 inhibitor, capsule, taken orally per protocol |
| Low Dose Cytarabine | DRUG | LDAC administered subcutaneously (SC) |
| Decitabine | DRUG | Decitabine administered intravenously |
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%...
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FHD-286 is an investigational small molecule being studied for the treatment of advanced hematologic malignancies, including relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, and chronic myelomonocytic leukemia, as well as POU2F3-positive small cell lung cancer. It is currently in clinical development and is not yet approved by the FDA.
FHD-286 is a SMARCA4/2 inhibitor, meaning it targets the SMARCA4 and SMARCA2 proteins, which are part of the SWI/SNF chromatin remodeling complex. By inhibiting these targets, FHD-286 aims to disrupt cancer cell growth in certain malignancies.
FHD-286 is being developed by Foghorn Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FHTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced cancers.
FHD-286 is in Phase 1 clinical development for advanced hematologic malignancies, with an active trial (NCT04891757) that is not yet recruiting participants. A separate Phase 2 trial (NCT07551635) for small cell lung cancer has been planned but has not yet started recruiting.
FHD-286 is being studied in two clinical trials. NCT04891757 is a Phase 1 trial evaluating FHD-286 as monotherapy or combination therapy in patients with advanced hematologic malignancies, with an enrollment of 144 participants. NCT07551635 is a Phase 2 trial for POU2F3-positive small cell lung cancer, with an enrollment of 20 participants.
Yes, FHD-286 is a SMARCA4/2 inhibitor. It is designed to inhibit the SMARCA4 and SMARCA2 proteins, which are involved in chromatin remodeling. This mechanism is being investigated for its potential to treat certain cancers, including hematologic malignancies and small cell lung cancer.