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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation and Dose Expansion of XmAb541 | Experimental | Intravenous or Subcutaneous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb541 | Biological | Monoclonal bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Day 1 to 2 years | |
| Incidence of dose-limiting toxicities (DLTs) | Day 1 to Day 28 | |
| Incidence of cytokine release syndrome (CRS) | Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Cmax | Peak plasma concentration | Day 1 to 2 years |
| Measurement of area under curve (AUC) | Area under the plasma concentration versus time curve |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XmAb541-01 Central Contact | Contact | info541-01@xencor.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States | |
| Stanford |
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Dose escalation and expansion study
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| Day 1 to 1.4 years |
| Measurement of Ctrough | Plasma concentration before next dose | Day 1 to 2 years |
| Objective Response Rate | Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging | Day 1 to 2 years |
| Duration of Response | Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging | Day 1 to 2 years |
| Changes in Circulating Tumor DNA (ctDNA) | Maximum variant frequency or mean/median variant frequency | Day 1 to 4 months |
| Recruiting |
| Palo Alto |
| California |
| 94304 |
| United States |
| University of California | Recruiting | San Francisco | California | 94158 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| The John Theruer Cancer Center at Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Montefiore Einstein Comprehensive Cancer Center | Recruiting | The Bronx | New York | 10461 | United States |
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
| OU Health Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
| Herlev Gentofte Hospital | Not yet recruiting | Herlev | 2730 | Denmark |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D009370 | Neoplasms by Histologic Type |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
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