Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FT825 · 1 trial · 1 indication
The number of participants with DLTs will be reported.
The number of participants with TEAEs will be reported.
Severity of AEs will be determined according to appropriate rating scales for the type of event reported.
| Arm | Type | Description |
|---|---|---|
| Regimen A: FT825 | EXPERIMENTAL | Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). |
| Regimen B: FT825 + Cetuximab | EXPERIMENTAL | Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). |
| Name | Type | Description |
|---|---|---|
| FT825 | DRUG | FT825 will be administered as an intravenous (IV) infusion at planned dose levels. |
| Fludarabine | DRUG | Fludarabine will be administered as an IV infusion at planned dose levels. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered as an IV infusion at planned dose levels. |
| Bendamustine | DRUG | Bendamustine will be administered as an IV infusion at planned dose levels. |
| Docetaxel | DRUG | Docetaxel will be administered as an IV infusion at planned dose levels. |
| Cisplatin | DRUG | Cisplatin will be administered as an IV infusion at planned dose levels. |
| Cetuximab | DRUG | Cetuximab will be administered as an IV infusion at planned dose levels. |
Inclusion Criteria: * Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria * Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types * Contraceptive use by women and men should be consi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
FT825 is an investigational cell therapy being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, with a trial evaluating its safety and efficacy in patients with this condition.
FT825 targets HER2, a protein found on the surface of some cancer cells. By targeting HER2, FT825 is designed to recognize and attack tumor cells that express this protein, potentially offering a therapeutic option for patients with HER2-positive advanced solid tumors.
FT825 is being developed by Fate Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol FATE. The company is conducting clinical trials to evaluate the safety and efficacy of FT825 in patients with advanced solid tumors.
FT825 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.
FT825 is being evaluated in a Phase 1 clinical trial with the identifier NCT06241456. This trial, titled 'FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors,' is recruiting participants in the United States and aims to enroll 351 patients.
FT825 is also known as ONO-8250, as indicated by the clinical trial title. The trial evaluates FT825/ONO-8250, suggesting these names refer to the same investigational therapy being developed for advanced solid tumors.