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 in Head and Neck Squamous Cell Carcinoma and other advanced solid tumors. It is not approved for any indication and remains in clinical development. The Phase 1 study also enrolled patients with melanoma, non-small cell lung cancer, urothelial carcinoma, renal cell carcinoma, prostate cancer, ovarian cancer, triple-negative breast cancer, and colorectal cancer.
XmAb808 targets B7-H3, a protein expressed on tumor cells and associated with immune regulation in the tumor microenvironment. By binding B7-H3, the antibody is designed to direct immune activity toward B7-H3-expressing tumor cells. B7-H3 is the molecular target of XmAb808, and the drug is being evaluated in combination with pembrolizumab.
XmAb808 is being developed by Xencor, Inc., a clinical-stage biopharmaceutical company that trades on the Nasdaq under the ticker XNCR. Xencor designed XmAb808 using its XmAb antibody engineering platform and is the sponsor of the clinical program evaluating the candidate in advanced solid tumors.
XmAb808 is in Phase 1 clinical development. It has not been approved by the FDA or any other regulatory agency and is investigational. The Phase 1 first-in-human study has been completed, and no active trials of XmAb808 are currently listed.
XmAb808 was evaluated in one Phase 1 clinical trial, NCT05585034, titled a Phase 1, first-in-human, dose-finding and expansion study of XmAb808 in combination with pembrolizumab in advanced solid tumors. The trial enrolled 60 participants across sites in the United States and is listed as completed. It was an uncontrolled, non-randomized, open-label study in adults 18 years and older.
Yes, XmAb808 and XmAb®808 refer to the same investigational monoclonal antibody developed by Xencor, Inc. XmAb®808 is the registered trademark styling of the name, while XmAb808 is the plain-text form used in company and clinical communications. Both names refer to the B7-H3-targeted antibody studied in NCT05585034.