Back to resultsA Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-CD352A
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility 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.
Sites / Locations
- Mayo Clinic Arizona
- City of Hope National Medical Center
- Winship Cancer Institute / Emory University School of Medicine
- Holden Comprehensive Cancer Center / University of Iowa
- Karmanos Cancer Institute / Wayne State University
- Washington University School of Medicine
- Hackensack University Medical Center
- Weill Cornell Medical College
- Charles A. Sammons Cancer Center / Baylor University Medical Center
- Swedish Cancer Institute
- Fred Hutchinson Cancer Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
(Dose Escalation) Cohort -1 - 6
Arm Description
SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.
Outcomes
Primary Outcome Measures
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
Incidence of dose-limiting toxicity
Secondary Outcome Measures
Overall survival
Progression-free survival
Duration of objective response
Duration of complete response
Objective response rate
Complete response rate
Incidence of antitherapeutic antibodies (ATA)
Blood concentrations of SGN-CD352A and metabolites
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02954796
Brief Title
A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma
Official Title
Phase 1 Study of SGN-CD352A in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision based on portfolio prioritization
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(Dose Escalation) Cohort -1 - 6
Arm Type
Experimental
Arm Description
SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.
Intervention Type
Drug
Intervention Name(s)
SGN-CD352A
Intervention Description
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 Measure Information:
Title
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
Time Frame
Through 1 month following last dose.
Title
Incidence of dose-limiting toxicity
Time Frame
During Cycle 1 (Trial Days 1-28)
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to approximately 3 years
Title
Progression-free survival
Time Frame
Up to approximately 3 years
Title
Duration of objective response
Time Frame
Up to approximately 3 years
Title
Duration of complete response
Time Frame
Up to approximately 3 years
Title
Objective response rate
Time Frame
Up to approximately 3 years
Title
Complete response rate
Time Frame
Up to approximately 3 years
Title
Incidence of antitherapeutic antibodies (ATA)
Time Frame
Up to approximately 3 years
Title
Blood concentrations of SGN-CD352A and metabolites
Time Frame
Up to approximately 3 years
Other Pre-specified Outcome Measures:
Title
Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects
Time Frame
Up to approximately 3 years
Title
CD352 characterization on malignant plasma cells
Time Frame
Up to approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Campbell, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Winship Cancer Institute / Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Holden Comprehensive Cancer Center / University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Karmanos Cancer Institute / Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Charles A. Sammons Cancer Center / Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of SGN-CD352A for Patients With Relapsed/Refractory Multiple Myeloma
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