Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT-1101 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Dose Escalation FT-1101 | EXPERIMENTAL | Following a 3+3 dose escalation strategy, the first cohort of patients will be administered FT-1101 at 10 mg, oral capsules, once weekly on a continuous basis. Subsequent cohorts dose and frequency will be determined by investigators and sponsor following observations of previous cohorts. Dose escalation will continue until the MTD is determined. |
| Dose Expansion FT-1101 | EXPERIMENTAL | Once the MTD is determined, the Recommended Phase 2 Dose (RP2D) will be identified. 3 Expansion cohorts of up to 20 patients each will be treated with the RP2D of FT-1101 |
| Dose Escalation FT-1101 + azacitidine | EXPERIMENTAL | Following a 3+3 dose escalation strategy, the first cohort of AML/MDS patients will be administered FT-1101 at approximately 50% or lower than the MTD identified for the single agent FT-1101. Subsequent cohorts dose will be determined by investigators and sponsor following observations of previous cohorts. Dose escalation will not exceed the dose determined to be the single agent MTD for that schedule. |
| Dose Expansion FT-1101 + azacitidine | EXPERIMENTAL | Once the MTD is determined, the Recommended Phase 2 Dose (RP2D) will be identified. 1 Expansion cohorts of up to 20 AML/MDS patients each will be treated with the RP2D of FT-1101 in combination with azacitidine. |
| Name | Type | Description |
|---|---|---|
| FT-1101 | DRUG | FT-1101 will be supplied as 5 mg, 20 mg or 100 mg capsules and will be administered per the protocol defined frequency and dose level |
| Azacitidine | DRUG | Azacitidine will be administered per site's standard of care |
Key Inclusion Criteria: * Single agent (SA) Dose Escalation: Histologically or cytologically proven acute leukemia or high-risk MDS as defined by the World Health Organization (WHO) criteria and IPSS-R, respectively, that is relapsed or refractory (R/R) to standard therapy or for whom standard trea...
FT-1101 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It was evaluated in a Phase 1 clinical trial in patients with relapsed or refractory hematologic malignancies, including AML, acute myelogenous leukemia, myelodysplastic syndrome, and non-Hodgkin lymphoma.
FT-1101 is a BET inhibitor, meaning it targets bromodomain and extraterminal (BET) proteins. BET inhibitors work by disrupting the interaction between BET proteins and acetylated histones, which can alter gene expression involved in cancer cell growth and survival.
FT-1101 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The drug is currently in clinical development for oncology indications.
FT-1101 is in Phase 1 clinical development. It has completed a Phase 1 trial, and it remains an investigational drug that is not yet approved by regulatory authorities. The completed trial was a controlled, non-randomized, open-label study.
FT-1101 has been studied in one clinical trial, identified as NCT02543879. This was a Phase 1 study titled 'Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies.' The trial enrolled 94 participants in the United States and has been completed.
FT-1101 is a unique investigational compound and is not known to be the same as any other marketed drug. It is a novel BET inhibitor developed by Novo Nordisk for the treatment of hematologic malignancies, including acute myeloid leukemia.