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| ID | Type | Description | Link |
|---|---|---|---|
| DUET-3 | Other Identifier | Xencor, Inc. |
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XmAb®23104 Monotherapy | Experimental | XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles |
|
| XmAb®23104 Combination Therapy with Ipilimumab | Experimental | XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb®23104 | Biological | Monoclonal bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related adverse events as assessed by CTCAE v4.03 | Safety and tolerability | 56 Days |
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Inclusion Criteria:
Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
Histologically or cytologically confirmed advanced solid tumors, including the following:
Subjects in Part B (expansion) must have a diagnosis of any of the following:
Histologically or cytologically confirmed advanced solid tumors of the following types:
Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
Subjects in Part C (expansion)must have a diagnosis of MSS or proficient mismatch repair CRC with the following:
All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
Subjects must have measurable disease by RECIST 1.1.
All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
All subjects in Part B (dose expansion) must have a tumor lesion that can be biopsied at acceptable risk (in the judgment of the Investigator) and must agree to both a fresh biopsy during screening and a second biopsy following treatment.
Subjects have an ECOG performance status of 0-1.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chet Bohac, MD, MSc | Xencor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | San Diego | California | 92093 | United States | ||
| University of Colorado Hospital - Anschutz Cancer Pavilion |
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| Yervoy® (ipilimumab) | Biological | Monoclonal antibody |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University School of Medicine Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Duke Cancer Institute | Durham | North Carolina | 27710 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| University of Pennsylvania Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Mary Crowley Cancer Research - Medical City | Dallas | Texas | 75230 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Emily Couric Clinical Cancer Center | Charlottesville | Virginia | 22903 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002583 | Uterine Cervical Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D002295 | Carcinoma, Transitional Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D000077274 | Nasopharyngeal Carcinoma |
| D002292 | Carcinoma, Renal Cell |
| D015179 | Colorectal Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| D064726 | Triple Negative Breast Neoplasms |
| D008113 | Liver Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013274 | Stomach Neoplasms |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D008107 | Liver Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D009303 | Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D001745 | Urinary Bladder Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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