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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05585034 | Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors | PHASE1 | COMPLETED | 60 | — | — | Dec 14, 2022 | May 20, 2025 | Aug 7, 2025 | 12 | United States |
Safety and tolerability as assessed by incidence of TEAEs, including clinically significant changes in safety laboratory tests and clinical findings
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 XmAb®808 administered in combination with pembrolizumab | EXPERIMENTAL | XmAb®808 in combination with pembrolizumab |
| Name | Type | Description |
|---|---|---|
| XmAb®808 | BIOLOGICAL | Monoclonal bispecific antibody |
| Keytruda® (pembrolizumab) | BIOLOGICAL | Monoclonal antibody |
Key Inclusion Criteria: * Part A: Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast can...