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A Safety Study of SGN-CD48A in Patients With 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. Identifier: NCT03379584
Recruitment Status : Terminated (Due to overall benefit/risk profile)
First Posted : December 20, 2017
Last Update Posted : September 18, 2019
Information provided by (Responsible Party):
Seagen Inc.

Brief Summary:
This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: SGN-CD48A Phase 1

Detailed Description:

This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts:

  1. Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose.

    The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design.

  2. Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: SGN-CD48A
Drug: SGN-CD48A
Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle

Primary Outcome Measures :
  1. Type, incidence, severity, seriousness, and relatedness of adverse events [ Time Frame: Through 1 month following last dose ]
  2. Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  3. Incidence of dose limiting toxicity [ Time Frame: Through 3 weeks following first dose ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: Through 1 month following last dose ]
    The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator

  2. Complete response rate [ Time Frame: Through 1 month following last dose ]
    The proportion of patients with stringent complete response or complete response per investigator

  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. Progression-free survival [ Time Frame: Up to approximately 3 years ]
  6. Overall survival [ Time Frame: Up to approximately 3 years ]
  7. Blood concentrations of SGN-CD48A and metabolites [ Time Frame: Through 1 month following last dose ]
  8. Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])
  • Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
  • Measureable 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 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
  • Adequate hematologic, renal, and hepatic function
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than 3 months
  • A negative pregnancy test (for females of childbearing potential)
  • Patients must provide written consent

Exclusion Criteria:

  • Pre-existing peripheral neuropathy Grade 2 or higher
  • History of malignancy other than MM within the past 3 years
  • Active cerebral/meningeal disease related to the underlying malignancy
  • Uncontrolled Grade 3 or higher infection
  • Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
  • Previous allogeneic stem cell transplant
  • History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months
  • Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
  • Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
  • 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 identifier (NCT number): NCT03379584

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United States, California
University of California at San Francisco
San Francisco, California, United States, 94134
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Seagen Inc.
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Study Director: Suzanne McGoldrick, MD, MPH Seagen Inc.
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Responsible Party: Seagen Inc. Identifier: NCT03379584    
Other Study ID Numbers: SGN48A-001
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
Multiple myeloma
Antibody-drug conjugate
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases