Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XmAb819 · 1 trial · 1 indication
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...
XmAb819 is an investigational monoclonal antibody being developed for the treatment of advanced Clear Cell Renal Cell Carcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with this specific type of kidney cancer.
XmAb819 targets ENPP3, a protein expressed on the surface of certain cells. By binding to ENPP3, the antibody is designed to direct an immune response against tumor cells that express this protein. This mechanism is being evaluated in the context of Clear Cell Renal Cell Carcinoma.
XmAb819 is being developed by Xencor, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol XNCR. Xencor is responsible for the clinical development and manufacturing of this investigational antibody therapy.
XmAb819 is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is recruiting patients to evaluate the safety, tolerability, and preliminary efficacy of XmAb819 in advanced Clear Cell Renal Cell Carcinoma.
XmAb819 is being studied in a single Phase 1 clinical trial registered as NCT05433142. This open-label, uncontrolled study is recruiting approximately 307 participants with advanced Clear Cell Renal Cell Carcinoma across multiple sites in the United States, Belgium, France, Spain, and the United Kingdom.
No, XmAb819 is not the same as ENPP3. ENPP3 is the molecular target that XmAb819 binds to. XmAb819 is a monoclonal antibody designed to recognize and attach to ENPP3, which is a protein found on the surface of certain cells, including tumor cells in Clear Cell Renal Cell Carcinoma.