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

Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: SGN-CD352A

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope National Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute / Emory University School of Medicine
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Holden Comprehensive Cancer Center / University of Iowa
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute / Wayne State University
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
  • Texas
    • Dallas, Texas, United States, 75246
      • Charles A. Sammons Cancer Center / Baylor University Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Up to approximately 3 years
Progression-free survival	Up to approximately 3 years
Incidence of antitherapeutic antibodies (ATA)	Up to approximately 3 years
Duration of objective response	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
Blood concentrations of SGN-CD352A and metabolites	Up to approximately 3 years

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seagen Inc.
• Investigators: Study Director: Mary Campbell, MD, Seagen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 3, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: SGN352-001