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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05433142 | Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma | PHASE1 | RECRUITING | 307 | — | — | Jun 13, 2022 | Dec 1, 2028 | Mar 5, 2026 | 23 | United States, France +2 |
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation and Expansion | EXPERIMENTAL | Dose Escalation will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose. Dose Expansion may administer XmAb819 IV, and XmAb819 SC. |
| Name | Type | Description |
|---|---|---|
| XmAb819 | BIOLOGICAL | Monoclonal Bispecific Antibody |
Inclusion Criteria: * Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. * Sub...