Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XmAb808 · 1 trial · 9 indications
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...
XmAb808 is an investigational monoclonal antibody being studied for the treatment of Head and Neck Squamous Cell Carcinoma. It is being evaluated in combination with pembrolizumab in a Phase 1 clinical trial for advanced solid tumors, including this indication. The drug is still in clinical development and is not yet approved.
XmAb808 targets B7-H3, a protein that is part of the B7 family of immune checkpoint molecules. By binding to B7-H3, the antibody is designed to modulate immune responses in the tumor microenvironment. This mechanism is being explored in the context of combination therapy for advanced solid tumors.
XmAb808 is being developed by Xencor, Inc., a biopharmaceutical company traded on NASDAQ under the ticker XNCR. Xencor is conducting clinical research on this investigational antibody for oncology indications, including Head and Neck Squamous Cell Carcinoma.
XmAb808 is in Phase 1 clinical development. A first-in-human, dose-finding and expansion study (NCT05585034) has been completed, evaluating the drug in combination with pembrolizumab in advanced solid tumors. The drug remains investigational and has not received FDA approval.
XmAb808 has been studied in one clinical trial, NCT05585034, a Phase 1, first-in-human, dose-finding and expansion study. This trial evaluated XmAb808 in combination with pembrolizumab in advanced solid tumors, including Head and Neck Squamous Cell Carcinoma, and enrolled 60 participants in the United States.
No, XmAb808 is not the same as pembrolizumab. XmAb808 is an investigational monoclonal antibody targeting B7-H3, developed by Xencor. Pembrolizumab is a separate, approved PD-1 inhibitor. In the clinical trial NCT05585034, XmAb808 is being studied in combination with pembrolizumab, not as the same drug.