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XmAb541 · 2 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Dose Escalation and Dose Expansion of XmAb541 and XmAb808 | EXPERIMENTAL | - |
| Dose escalation and Dose Expansion of XmAb541 | EXPERIMENTAL | Intravenous or Subcutaneous administration |
| Name | Type | Description |
|---|---|---|
| XmAb541 | BIOLOGICAL | Monoclonal Bispecific Antibody |
| XmAb808 | BIOLOGICAL | Monoclonal Bispecific Antibody |
Inclusion Criteria: * Age ≥ 18 years. * CLDN6+ tumor * Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin * Adequate Eastern Cooperative Oncology Group performance ...
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XmAb541 is an investigational monoclonal antibody being studied for the treatment of ovarian cancer and other advanced solid tumors. It is also being evaluated in endometrial cancer, germ cell tumors, testicular germ cell tumors, and ovarian germ cell tumors. It has not been approved for any use and remains in clinical development.
XmAb541 targets CLDN6, a protein in the claudin family. CLDN6 is a tight junction protein that is expressed in certain solid tumors, including ovarian cancer. By binding CLDN6, XmAb541 is designed to direct an immune response against tumor cells that express this target.
XmAb541 is being developed by Xencor, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol XNCR. Xencor designs engineered monoclonal antibodies and other protein therapeutics, and XmAb541 is part of its oncology pipeline.
XmAb541 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is evaluating safety and tolerability in patients with advanced solid tumors, including ovarian cancer.
XmAb541 is being studied in two recruiting Phase 1 trials. NCT06276491 evaluates XmAb541 in advanced solid tumors including ovarian, endometrial, and germ cell tumors across the United States and several European countries. NCT07593092 evaluates XmAb541 together with XmAb808 in advanced solid tumors, including ovarian cancer, in the United States.
The two Phase 1 trials of XmAb541 have a combined planned enrollment of 372 participants. NCT06276491 plans to enroll 282 patients, and NCT07593092 plans to enroll 90 patients. Both studies are currently recruiting and neither is randomized or controlled.