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

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ClinicalTrials.gov Identifier: NCT03309111
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Glenmark Pharmaceuticals S.A.

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Biological: GBR 1342 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Maximal Tolerated Dose (MTD) of GBR 1342 (Part 1) [ Time Frame: 28 days ]
    MTD will be assessed by detection of number of DLTs (dose limiting toxicities) during the first 28 days after the first administration of study drug (i.e. Cycle 1) in each cohort

  2. Objective response to GBR 1342 according to International Myeloma Working Group (IMWG) response criteria (Part 2) [ Time Frame: 28 days ]
  3. Frequency and severity of AEs according to CTCAEv4.03 [ Time Frame: 28 days ]
    The relationship of the dose of GBR 1342 with frequency and severity of AEs will be assessed based on CTCAEv4.03.


Secondary Outcome Measures :
  1. Maximum serum concentration (Cmax) of GBR 1342 [ Time Frame: 28 days ]
  2. Area under the serum concentration time curve from zero to time t (AUC0-t) of GBR 1342 [ Time Frame: 28 days ]
  3. Immunogenicity of GBR 1342 by anti-drug antibody (ADA) formation assessed from baseline until end of treatment [ Time Frame: 28 days ]
  4. Anti-tumor activity of GBR 1342 (Disease control rate) [ Time Frame: 28 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309111


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

Locations
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United States, Arkansas
Glenmark Investigational Site 2 Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Faith Davies, MD       FEDavies@uams.edu   
United States, Colorado
Glenmark Investigational Site 10 Not yet recruiting
Denver, Colorado, United States, 80218
Contact: Jeffrey Matous, MD       jeffrey.matous@HealthOneCares.com   
United States, Maryland
Glenmark Investigational Site 3 Recruiting
Baltimore, Maryland, United States, 21287
Contact: Carol Ann Huff, MD       huffca@jhmi.edu   
United States, New Jersey
Glenmark Investigational Site 1 Recruiting
Hackensack, New Jersey, United States, 07601
Contact: David Vesole, MD, PhD       david.vesole@hackensackmeridian.org   
United States, New York
Glenmark Investigational Site 6 Recruiting
New York, New York, United States, 10029
Contact: Joshua Richter, MD       Joshua.Richter@mssm.edu   
Glenmark Investigational Site 4 Recruiting
New York, New York, United States, 10065
Contact: Eric Smith, MD, PhD       smithe3@mskcc.org   
United States, Tennessee
Glenmark Investigational Site 9 Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jesus Berdeja, MD       jberdeja@tnonc.com   
Glenmark Investigational Site 5 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Robert Cornell, MD       robert.f.cornell@vanderbilt.edu   
United States, Wisconsin
Glenmark Investigational Site 7 Recruiting
Madison, Wisconsin, United States, 53792
Contact: Aric Hall, MD       achall@medicine.wisc.edu   
Sponsors and Collaborators
Glenmark Pharmaceuticals S.A.
Investigators
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Study Director: Ewa Matczak, MD Glenmark Pharmaceutical S.A

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Responsible Party: Glenmark Pharmaceuticals S.A.
ClinicalTrials.gov Identifier: NCT03309111     History of Changes
Other Study ID Numbers: GBR 1342-101
2016-005253-20 ( EudraCT Number )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases