Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ICON Clinical Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the safety and tolerability of intravenous (IV) and subcutaneous (SC) administration of XmAb13676 and to determine the maximally tolerated dose (MTD) and/or recommended dose (RD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-CLL B Cell Malignancies (Group NHL) Part A | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
|
| CLL/SLL (Group CLL) Part A | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
|
| Non-CLL B Cell Malignancies (Group NHL) Part B | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
|
| CLL/SLL (Group CLL) Part B | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
|
| Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion | Experimental | XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb13676 | Biological | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03 | Baseline Day 1 through Day 56 | |
| Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing | Baseline Day 1 through Day 56 |
Not provided
Not provided
Inclusion Criteria:
Additional Patient Inclusion Criteria for the DLBCL Cohort (Expansion Phase)
Additional Patient Inclusion Criteria for the Follicular Lymphoma Cohort (Expansion Phase)
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chet Bohac, PharmD, MD, MSc | Executive Medical Director, Clinical Development, Xencor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores UC San Diego Cancer Center | La Jolla | California | 92093 | United States | ||
| Mayo Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will enroll two parallel disease groups in escalation: patients with non-CLL B cell malignancies and patients with CLL/SLL/Richter's Transformation. In expansion it will enroll DLBCL and FL
Not provided
Not provided
Not provided
Not provided
| Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion | Experimental | XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion |
|
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| The University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| The Ohio State University Wexner Medical Center and James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| UVA Health System, Division of Hematology & Oncology | Charlottesville | Virginia | 22908 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | 33076 | France |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Institut Paoli Calmette Dpt of Oncology/Hematology | Marseille | 13273 | France |
| Chu Montpellier, Hematologie Clinique St. Eloi | Montpellier | 34295 | France |
| CHU de Nantes | Nantes | 44000 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| CHU Haut-Leveque, Service d'Hematologie Clinique et Therapie Cellulaire | Pessac | 33604 | France |
| Centre Hospitalier Lyon-Sud, Service d'Hematologie | Pierre-Bénite | 69495 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Institut Universitaire du Cancer Toulouse Oncopole | Toulouse | 31100 | France |
| CLCC Institut Gustave Roussy | Villejuif | 94805 | France |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D054403 | Leukemia, Prolymphocytic, B-Cell |
| D002051 | Burkitt Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| D007943 | Leukemia, Hairy Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| D007938 | Leukemia |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D046248 | Pyloric Stenosis, Hypertrophic |
| D008230 | Lymphomatoid Granulomatosis |
| D000069293 | Plasmablastic Lymphoma |
| D054685 | Lymphoma, Primary Effusion |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015463 | Leukemia, Prolymphocytic |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011230 | Precancerous Conditions |
Not provided
Not provided