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

NCT02954796 | Terminated Phase 1 DMC

• 1 other identifier: SGN352-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 11

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Overall survival

  Up to approximately 3 years

• Progression-free survival

  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

Other Outcomes (2)

• Exploratory biomarkers of SGN CD352A- mediated pharmacodynamic effects

  Up to approximately 3 years

• CD352 characterization on malignant plasma cells

  Up to approximately 3 years

Study Arms (1)

(Dose Escalation) Cohort -1 - 6

EXPERIMENTAL

SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.

Drug: SGN-CD352A

Interventions

SGN-CD352A DRUG

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.

(Dose Escalation) Cohort -1 - 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (11)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

City of Hope National Medical Center

Duarte, California, 91010-3000, United States

Location

Winship Cancer Institute / Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Holden Comprehensive Cancer Center / University of Iowa

Iowa City, Iowa, 52242, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Charles A. Sammons Cancer Center / Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mary Campbell, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 3, 2016
• Study Start: December 1, 2016
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Locations

US (11)