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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309111
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Ichnos Sciences SA

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE October 16, 2017
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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
  • Objective response to GBR 1342 according to International Myeloma Working Group (IMWG) response criteria (Part 2) [ Time Frame: 28 days ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • Maximum serum concentration (Cmax) of GBR 1342 [ Time Frame: 28 days ]
  • Area under the serum concentration time curve from zero to time t (AUC0-t) of GBR 1342 [ Time Frame: 28 days ]
  • Immunogenicity of GBR 1342 by anti-drug antibody (ADA) formation assessed from baseline until end of treatment [ Time Frame: 28 days ]
  • Anti-tumor activity of GBR 1342 (Disease control rate) [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of GBR 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Official Title  ICMJE A Phase 1/2, First-in-Human, Multicenter, Open-Label, Two Part Dose- Escalation and Cohort Expansion Study of Single-Agent GBR 1342 in Subjects With Previously Treated Multiple Myeloma
Brief Summary The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: GBR 1342
Open-label dose escalation of GBR 1342
Intervention: Biological: GBR 1342
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
125
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with progressive or relapsed multiple myeloma (by IMWG) refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs) and daratumumab.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ichnos CT Disclosure Desk (201) 331-4000 clinicaltrialsdisclosuredesk@ichnossciences.com
Listed Location Countries  ICMJE United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03309111
Other Study ID Numbers  ICMJE GBR 1342-101
2016-005253-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ichnos Sciences SA
Study Sponsor  ICMJE Ichnos Sciences SA
Collaborators  ICMJE Glenmark Pharmaceuticals S.A.
Investigators  ICMJE
Study Director: Mikhail Khazan, MD Ichnos Sciences
PRS Account Ichnos Sciences SA
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP