Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
- Conditions
- Ovarian CancerEndometrial CancerOvarian Germ Cell TumorGerm Cell TumorTesticular Germ Cell Tumor
- Interventions
- Registration Number
- NCT06276491
- Lead Sponsor
- Xencor, Inc.
- Brief Summary
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 212
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation and Dose Expansion of XmAb541 XmAb541 Intravenous or Subcutaneous administration
- Primary Outcome Measures
Name Time Method Incidence of adverse events Day 1 to 2 years Incidence of cytokine release syndrome (CRS) Day 1 to Day 28 Incidence of dose-limiting toxicities (DLTs) Day 1 to Day 28
- Secondary Outcome Measures
Name Time Method Measurement of Cmax Day 1 to 2 years Peak plasma concentration
Measurement of Ctrough Day 1 to 2 years Plasma concentration before next dose
Changes in Circulating Tumor DNA (ctDNA) Day 1 to 2 years Maximum variant frequency or mean/median variant frequency
Measurement of area under curve (AUC) Day 1 to 1.4 years Area under the plasma concentration versus time curve
Objective Response Rate Day 1 to 2 years Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Duration of Response Day 1 to 2 years Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Trial Locations
- Locations (9)
Winship Cancer Institute, Emory University
🇺🇸Atlanta, Georgia, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
The John Theruer Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Montefiore Einstein Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
OU Health Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States