Clinical trial NCT02954796: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
timeFrame: Through 1 month following last dose.
measure: Incidence of dose-limiting toxicity
timeFrame: During Cycle 1 (Trial Days 1-28)
Secondary outcomes:
measure: Overall survival
timeFrame: Up to approximately 3 years
measure: Progression-free survival
timeFrame: Up to approximately 3 years
measure: Duration of objective response
timeFrame: Up to approximately 3 years
measure: Duration of complete response
timeFrame: Up to approximately 3 years
measure: Objective response rate
timeFrame: Up to approximately 3 years
measure: Complete response rate
timeFrame: Up to approximately 3 years
measure: Incidence of antitherapeutic antibodies (ATA)
timeFrame: Up to approximately 3 years
measure: Blood concentrations of SGN-CD352A and metabolites
timeFrame: Up to approximately 3 years
Other outcomes:
measure: Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects
timeFrame: Up to approximately 3 years
measure: CD352 characterization on malignant plasma cells
timeFrame: Up to approximately 3 years
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Atlanta
country: United States
facility: Winship Cancer Institute / Emory University School of Medicine
state: Georgia
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center / University of Iowa
state: Iowa
city: Detroit
country: United States
facility: Karmanos Cancer Institute / Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center / Baylor University Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Mary Campbell, MD
role: STUDY_DIRECTOR
References: