Safety and tolerability of XmAb541 in patients with advanced solid tumors
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
This study is testing a new drug called XmAb541 to see if it's safe and how well it works for people with advanced solid tumors like ovarian and endometrial cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 282 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Xencor, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 16 sites (Duarte, California and 15 other locations) |
| Trial ID | NCT06276491 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and tolerability of the investigational drug XmAb541 in patients with advanced solid tumors, specifically targeting ovarian cancer, endometrial cancer, and various germ cell tumors. The study aims to determine the optimal and safe dosage of XmAb541 while assessing its effects on tumor outcomes. Participants will be closely monitored for any adverse effects and overall response to the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with CLDN6+ tumors who have exhausted standard therapies and have documented progressive disease.
Not a fit: Patients with platinum refractory ovarian cancer or those who have previously been treated with a CLDN6 targeting product may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are difficult to treat.
How similar studies have performed: While this approach is novel in targeting CLDN6, similar studies targeting other tumor markers have shown promise in treating advanced cancers.
Eligibility criteria
Show full inclusion / exclusion 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 resistant to previous treatment * Adequate Eastern Cooperative Oncology Group performance status * Life expectancy ≥ 3 months * Adequate liver, kidney, and bone marrow function Key Exclusion Criteria: * 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 * Active hepatitis B or hepatitis C
Where this trial is running
Duarte, California and 15 other locations
- City of Hope — Duarte, California, United States (Not_yet_recruiting)
- Stanford — Palo Alto, California, United States (Not_yet_recruiting)
- University of California — San Francisco, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Indian University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- The John Theruer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Montefiore Einstein Comprehensive Cancer Center — The Bronx, New York, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Gabrielle Golden
- Email: info541-01@xencor.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.