Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Ovarian Cancer; Endometrial Cancer; Germ Cell Tumor; Testicular Germ Cell Tumor; Ovarian Germ Cell Tumor

• Registration Number: NCT06276491
• Lead Sponsor: Xencor, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-2-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Key Inclusion Criteria:<br><br> - Age = 18 years. For subjects with GCTs, age =15 years<br><br> - CLDN6+ tumor<br><br> - Histological evidence of locally advanced, recurrent, or metastatic solid malignancy<br> Ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium<br> (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT<br><br> - Have documented progressive disease (PD) on standard-of-care therapies appropriate<br> for the specific tumor type; have exhausted therapies with a survival benefit or the<br> standard therapy has no survival benefit or proven to be ineffective, intolerable,<br> or subject is not a candidate for such available therapy.<br><br> - Eastern Cooperative Oncology Group performance status of 0-2<br><br> - Life expectancy = 3 months<br><br> - Adequate liver, kidney, and bone marrow function<br><br>Key Exclusion Criteria:<br><br> - Prior exposure to a CLDN6 targeting product<br><br> - Ovarian cancer that is platinum refractory, or has rapid progression on most recent<br> prior = second line systemic anticancer therapy<br><br> - Have known active central nervous system metastases and/or carcinomatous meningitis.<br> Patients with treated brain metastases may participate, provided they are<br> radiologically stable.<br><br> - Active known or suspected autoimmune disease<br><br> - Has any condition requiring systemic treatment with corticosteroids, prednisone<br> equivalents, or other immunosuppressive medications within 14 days prior to first<br> dose of study drug<br><br> - Clinically significant cardiovascular, pulmonary or gastrointestinal disease<br><br> - Positive test for hepatitis C RNA<br><br> - Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events;Incidence of dose-limiting toxicities (DLTs);Incidence of cytokine release syndrome (CRS)

Secondary Outcome Measures

Name	Time	Method
Measurement of Cmax;Measurement of area under curve (AUC);Measurement of Ctrough;Objective Response Rate;Duration of Response;Changes in Circulating Tumor DNA (ctDNA)