Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06241456 | FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors | PHASE1 | RECRUITING | 351 | — | — | Jan 5, 2024 | May 1, 2044 | Dec 9, 2025 | 14 | United States |
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, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |