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Sponsor decision based on portfolio prioritization
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This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe.
In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Dose Escalation) Cohort -1 - 6 | Experimental | SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-CD352A | Drug | On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe. |
| Measure | Description | Time Frame |
|---|---|---|
| Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities) | Through 1 month following last dose. | |
| Incidence of dose-limiting toxicity | During Cycle 1 (Trial Days 1-28) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to approximately 3 years | |
| Progression-free survival | Up to approximately 3 years | |
| Duration of objective response |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects | Up to approximately 3 years | |
| CD352 characterization on malignant plasma cells | Up to approximately 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Campbell, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Scottsdale | Arizona | 85259 | United States | ||
| City of Hope National Medical Center |
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|
| Up to approximately 3 years |
| Duration of complete response | Up to approximately 3 years |
| Objective response rate | Up to approximately 3 years |
| Complete response rate | Up to approximately 3 years |
| Incidence of antitherapeutic antibodies (ATA) | Up to approximately 3 years |
| Blood concentrations of SGN-CD352A and metabolites | Up to approximately 3 years |
| Duarte |
| California |
| 91010-3000 |
| United States |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Holden Comprehensive Cancer Center / University of Iowa | Iowa City | Iowa | 52242 | United States |
| Karmanos Cancer Institute / Wayne State University | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| Charles A. Sammons Cancer Center / Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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