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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07216105 | FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors | PHASE1 | RECRUITING | 113 | — | — | Nov 4, 2025 | Jan 1, 2030 | Apr 7, 2026 | 5 | United States |
The number of participants experiencing ≥1 DLT will be reported.
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
| Arm | Type | Description |
|---|---|---|
| Regimen A ( FT836) | EXPERIMENTAL | Participants receive FT836 monotherapy |
| Regimen B ( Paclitaxel + FT836) | EXPERIMENTAL | Participants receive Paclitaxel chemotherapy followed by FT836 |
| Regimen C ( Cetuximab + FT836) | EXPERIMENTAL | Participants receive FT836 combined with cetuximab |
| Regimen D ( Paclitaxel + Cetuximab + FT836) | EXPERIMENTAL | Participants receive Paclitaxel chemotherapy followed by FT836 combined with cetuximab |
| Regimen E ( Trastuzumab + FT836)) | EXPERIMENTAL | Participants receive FT836 combined with trastuzumab |
| Regimen F ( Paclitaxel + Trastuzumab + FT836) | EXPERIMENTAL | Participants receive Paclitaxel chemotherapy followed by FT836 combined with trastuzumab |
| Name | Type | Description |
|---|---|---|
| FT836 | DRUG | FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle. |
| Paclitaxel | DRUG | IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7 |
| Cetuximab | DRUG | Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion |
| Trastuzumab | DRUG | trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion. |
Inclusion Criteria: * For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy. * Evidence of adequate organ function as determined by all of the following: * Absolute neutrophil count (ANC) \>100...