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Study of ISB 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. Identifier: NCT03309111
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 9, 2020
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Ichnos Sciences SA

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: ISB 1342 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, First-in-Human, Multicenter, Open-Label, Two Part Dose- Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

Primary Outcome Measures :
  1. Maximal Tolerated Dose (MTD) of ISB 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 ISB 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 ISB 1342 with frequency and severity of AEs will be assessed based on CTCAEv4.03.

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

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT03309111

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Contact: Ichnos CT Disclosure Desk (201) 786-3216

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United States, Arkansas
Ichnos Investigational Site 2 Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Maurizio Zengari, MD   
United States, Colorado
Ichnos Investigational Site 10 Recruiting
Denver, Colorado, United States, 80218
Contact: Jeffrey Matous, MD   
United States, Maryland
Ichnos Investigational Site 3 Recruiting
Baltimore, Maryland, United States, 21287
Contact: Carol Ann Huff, MD   
United States, New Jersey
Ichnos Investigational Site 1 Recruiting
Hackensack, New Jersey, United States, 07601
Contact: David Vesole, MD, PhD   
United States, New York
Ichnos Investigational Site 6 Recruiting
New York, New York, United States, 10029
Contact: Joshua Richter, MD   
Ichnos Investigational Site 4 Recruiting
New York, New York, United States, 10065
Contact: Eric Smith, MD, PhD   
United States, Tennessee
Ichnos Investigational Site 9 Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jesus Berdeja, MD   
Ichnos Investigational Site 5 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Robert Cornell, MD   
United States, Wisconsin
Ichnos Investigational Site 7 Recruiting
Madison, Wisconsin, United States, 53792
Contact: Aric Hall, MD   
Sponsors and Collaborators
Ichnos Sciences SA
Glenmark Pharmaceuticals S.A.
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Study Director: Mikhail Khazan, MD Ichnos Sciences
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Responsible Party: Ichnos Sciences SA Identifier: NCT03309111    
Other Study ID Numbers: ISB 1342-101
2016-005253-20 ( EudraCT Number )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
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
Keywords provided by Ichnos Sciences SA:
GBR 1342 CD38/CD3 Bispecific Antibody ISB 1342
GBR 1342 in Previously Treated Multiple Myeloma ISB 1342
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases