Study of GBR 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma

Purpose

The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.

Condition

  • Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males or females with multiple myeloma who have exhausted available standard therapies.
  • Measurable disease, defined as any quantifiable monoclonal protein value
  • ECOG performance-status score of 2 or less
  • Life expectancy of at least 3 months
  • Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug

Exclusion Criteria

  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.
  • Active infectious disease considered by the Investigator to be incompatible with the protocol.
  • Evidence of clinically significant cardiovascular and respiratory conditions
  • Anti-myeloma treatment within 2 weeks
  • Use of any investigational drug within the past 4 weeks

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GBR 1342
Open-label dose escalation of GBR 1342
  • Biological: GBR 1342
    GBR 1342 will be administered by intravenous (IV) infusion on Day 1 and Day 15 of each 28-day treatment cycle at escalating dose levels

Recruiting Locations

Glenmark Investigational Site 2
Little Rock, Arkansas 72205
Contact:
Faith Davies, MD
FEDavies@uams.edu

Glenmark Investigational Site 3
Baltimore, Maryland 21287
Contact:
Carol Ann Huff, MD
huffca@jhmi.edu

Glenmark Investigational Site 1
Hackensack, New Jersey 07601
Contact:
David Vesole, MD, PhD
david.vesole@hackensackmeridian.org

Glenmark Investigational Site 6
New York, New York 10029
Contact:
Joshua Richter, MD
Joshua.Richter@mssm.edu

Glenmark Investigational Site 4
New York, New York 10065
Contact:
Eric Smith, MD, PhD
smithe3@mskcc.org

Glenmark Investigational Site 9
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, MD
jberdeja@tnonc.com

Glenmark Investigational Site 5
Nashville, Tennessee 37232
Contact:
Robert Cornell, MD
robert.f.cornell@vanderbilt.edu

Glenmark Investigational Site 7
Madison, Wisconsin 53792
Contact:
Aric Hall, MD
achall@medicine.wisc.edu

More Details

NCT ID
NCT03309111
Status
Recruiting
Sponsor
Glenmark Pharmaceuticals S.A.

Study Contact

Vilia Dragovoy
(201) 684-8000
clinicaltrialsdisclosuredesk@glenmarkpharma.com