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A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02954796
Recruitment Status : Terminated (Sponsor decision based on portfolio prioritization)
First Posted : November 3, 2016
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SGN-CD352A Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 17, 2019
Actual Study Completion Date : July 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: (Dose Escalation) Cohort -1 - 6
SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.
Drug: SGN-CD352A
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.




Primary Outcome Measures :
  1. Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities) [ Time Frame: Through 1 month following last dose. ]
  2. Incidence of dose-limiting toxicity [ Time Frame: During Cycle 1 (Trial Days 1-28) ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to approximately 3 years ]
  2. Progression-free survival [ Time Frame: Up to approximately 3 years ]
  3. Duration of objective response [ Time Frame: Up to approximately 3 years ]
  4. Duration of complete response [ Time Frame: Up to approximately 3 years ]
  5. Objective response rate [ Time Frame: Up to approximately 3 years ]
  6. Complete response rate [ Time Frame: Up to approximately 3 years ]
  7. Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Up to approximately 3 years ]
  8. Blood concentrations of SGN-CD352A and metabolites [ Time Frame: Up to approximately 3 years ]

Other Outcome Measures:
  1. Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects [ Time Frame: Up to approximately 3 years ]
  2. CD352 characterization on malignant plasma cells [ Time Frame: Up to approximately 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG] ).
  • Age 18 years or older.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Life expectancy greater than 3 months.
  • Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
  • Measurable disease, as defined by at least one of the following: Serum M protein 0.5 g/dL or higher, Urine M protein 200 mg/24 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio.
  • Adequate hematologic, renal, and hepatic function
  • A negative pregnancy test (for females of childbearing potential).
  • Patients must provide written informed consent.

Exclusion Criteria:

  • Other invasive malignancy within the past 3 years.
  • Active cerebral/meningeal disease related to the underlying malignancy.
  • Active Grade 3 or higher infection.
  • Known to be positive for HIV or known to have active hepatitis B or C.
  • Previous allogeneic stem cell transplant.
  • Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
  • Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
  • Females who are pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954796


Locations
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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States, 30322
United States, Iowa
Holden Comprehensive Cancer Center / University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Texas
Charles A. Sammons Cancer Center / Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Mary Campbell, MD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02954796    
Other Study ID Numbers: SGN352-001
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases