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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02954796
• Other study ID #: SGN352-001
• Status: Terminated
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: July 17, 2019

Study information

• Verified date: August 2019
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
United States	Winship Cancer Institute / Emory University School of Medicine	Atlanta	Georgia
United States	Charles A. Sammons Cancer Center / Baylor University Medical Center	Dallas	Texas
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Holden Comprehensive Cancer Center / University of Iowa	Iowa City	Iowa
United States	Weill Cornell Medical College	New York	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects		Up to approximately 3 years
Other	CD352 characterization on malignant plasma cells		Up to approximately 3 years
Primary	Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)		Through 1 month following last dose.
Primary	Incidence of dose-limiting toxicity		During Cycle 1 (Trial Days 1-28)
Secondary	Overall survival		Up to approximately 3 years
Secondary	Progression-free survival		Up to approximately 3 years
Secondary	Duration of objective response		Up to approximately 3 years
Secondary	Duration of complete response		Up to approximately 3 years
Secondary	Objective response rate		Up to approximately 3 years
Secondary	Complete response rate		Up to approximately 3 years
Secondary	Incidence of antitherapeutic antibodies (ATA)		Up to approximately 3 years
Secondary	Blood concentrations of SGN-CD352A and metabolites		Up to approximately 3 years