Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

Launched by XENCOR, INC. · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called XmAb541 to see if it is safe and well tolerated for patients with advanced solid tumors, particularly types like ovarian cancer, endometrial cancer, and certain germ cell tumors. The main goal is to find the best and safest dose of the drug and to see how it affects tumor growth. The study is currently looking for participants who are at least 18 years old (or 15 years old for certain germ cell tumors) and have specific types of cancer that have not responded well to standard treatments.

To be eligible for this trial, participants must have a certain type of tumor that expresses a specific protein (CLDN6) and have documented disease progression despite previous treatments. Additionally, they need to be in reasonably good health, with a life expectancy of at least three months. If someone decides to join the study, they will receive the investigational drug and be closely monitored for any side effects and how their tumors respond. It's important to note that individuals with certain health conditions or who have previously received similar treatments may not be able to participate.

Gender

ALL

Eligibility criteria

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