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



Status:Recruiting
Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:October 16, 2017
End Date:April 2020
Contact:Vilia Dragovoy
Email:clinicaltrialsdisclosuredesk@glenmarkpharma.com
Phone:(201) 684-8000

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A Phase 1, First-in-Man, Multicenter, Open-Label, Two Part Dose- Escalation and Cohort Expansion Study of Single-Agent GBR 1342 in Subjects With Previously Treated Multiple Myeloma

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.


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
We found this trial at
7
sites
Nashville, Tennessee
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Baltimore, Maryland 21287
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Denver, Colorado 80218
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Hackensack, New Jersey 07601
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Little Rock, Arkansas 72205
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Madison, Wisconsin 53792
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Madison, WI
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New York, New York 10029
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New York, NY
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