Back to resultsA Safety Study of SGN-CD48A in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-CD48A
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple myeloma, Antibody-drug conjugate
Eligibility Criteria
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
Sites / Locations
- University of California at San Francisco
- Yale Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Mount Sinai Medical Center
- Levine Cancer Institute
- University of Pennsylvania / Perelman Center for Advanced Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SGN-CD48A
Arm Description
SGN-CD48A
Outcomes
Primary Outcome Measures
Type, incidence, severity, seriousness, and relatedness of adverse events
Incidence of laboratory abnormalities
Incidence of dose limiting toxicity
Secondary Outcome Measures
Objective response rate
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Complete response rate
The proportion of patients with stringent complete response or complete response per investigator
Duration of objective response
Duration of complete response
Progression-free survival
Overall survival
Blood concentrations of SGN-CD48A and metabolites
Incidence of antitherapeutic antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03379584
Brief Title
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma
Official Title
A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to overall benefit/risk profile
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
August 23, 2019 (Actual)
Study Completion Date
August 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple myeloma, Antibody-drug conjugate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SGN-CD48A
Arm Type
Experimental
Arm Description
SGN-CD48A
Intervention Type
Drug
Intervention Name(s)
SGN-CD48A
Intervention Description
Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle
Primary Outcome Measure Information:
Title
Type, incidence, severity, seriousness, and relatedness of adverse events
Time Frame
Through 1 month following last dose
Title
Incidence of laboratory abnormalities
Time Frame
Through 1 month following last dose
Title
Incidence of dose limiting toxicity
Time Frame
Through 3 weeks following first dose
Secondary Outcome Measure Information:
Title
Objective response rate
Description
The proportion of patients with stringent complete response, complete response, very good partial response, or partial response per investigator
Time Frame
Through 1 month following last dose
Title
Complete response rate
Description
The proportion of patients with stringent complete response or complete response per investigator
Time Frame
Through 1 month following last dose
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
Progression-free survival
Time Frame
Up to approximately 3 years
Title
Overall survival
Time Frame
Up to approximately 3 years
Title
Blood concentrations of SGN-CD48A and metabolites
Time Frame
Through 1 month following last dose
Title
Incidence of antitherapeutic antibodies
Time Frame
Through 1 month following last dose
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])
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne McGoldrick, MD, MPH
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
University of Pennsylvania / Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma
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