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Study of ISB 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 : June 4, 2021
Sponsor:
Collaborator:
Glenmark Pharmaceuticals S.A.
Information provided by (Responsible Party):
Ichnos Sciences SA

Brief Summary:
The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.

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

Detailed Description:
This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and daratumumab. There will be a dose escalation phase (Part 1) and dose expansion phase (Part 2). In Part 1 of the study, subjects will be treated at escalating dose levels. Once the recommended part 2 dose (RP2D) of ISB 1342 is declared in Part 1, the expansion phase (Part 2) will be initiated at the RP2D.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, 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 25, 2017
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: ISB 1342
Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met
Biological: ISB 1342
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion




Primary Outcome Measures :
  1. Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1) [ Time Frame: 28 days ]
  2. Investigator-assessed objective response (complete response [CR], stringent CR [sCR], partial response [PR], very good PR [VGPR], minimal response [MR]) to ISB 1342, according to international myeloma working group (IMWG) criteria (Part 2) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events based on relatedness and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 [ Time Frame: up to 30 days post last dose ]
  2. Maximum serum concentration (Cmax) of ISB 1342 [ Time Frame: 28 days ]
  3. Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 [ Time Frame: 28 days ]
  4. Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 [ Time Frame: 28 days ]
  5. Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 [ Time Frame: 28 days ]
  6. Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation [ Time Frame: 28 days ]
  7. Efficacy of ISB 1342 (duration of response [DOR]) (Part 2) [ Time Frame: 28 days ]
  8. Efficacy of ISB 1342 (disease control rate [DCR]) (Part 2) [ 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:

  • Documented diagnosis of relapsed/refractory multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria
  • Patients have received proteasome inhibitor, immunomodulator, and daratumumab
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less
  • Adequate hematologic, renal, and hepatic functions

Exclusion Criteria:

  • Active central nervous system involvement
  • Exposure to daratumumab within 6 months prior to the start of study treatment
  • Active plasma cell leukemia
  • Blood transfusion and/or granulocyte-(macrophage) colony-stimulating factor
  • Active infectious disease
  • Clinically significant cardiovascular and respiratory conditions
  • History of HIV infection or acute or chronic active hepatitis B or C infection

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: Ichnos Sciences Clinical Trials Administrator (315) 583-1249 clinicaltrials@ichnossciences.com

Locations
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United States, Arkansas
Ichnos Investigational Site 2 Withdrawn
Little Rock, Arkansas, United States, 72205
United States, Colorado
Ichnos Investigational Site 11 Terminated
Denver, Colorado, United States, 80218
United States, Maryland
Ichnos Investigational Site 3 Recruiting
Baltimore, Maryland, United States, 21287
Contact: Carol Ann Huff, MD       huffca@jhmi.edu   
United States, Minnesota
Ichnos Investigational Site 10 Recruiting
Rochester, Minnesota, United States, 55905
Contact: Prashant Kapoor, MD       Kapoor.Prashant@mayo.edu   
United States, New Jersey
Ichnos Investigational Site 1 Terminated
Hackensack, New Jersey, United States, 07601
United States, New York
Ichnos Investigational Site 5 Recruiting
New York, New York, United States, 10029
Contact: Joshua Richter, MD       joshua.richter@mountsinai.org   
Ichnos Investigational Site 7 Recruiting
New York, New York, United States, 10065
Contact: Alexander Lesokhin, MD       lesokhia@mskcc.org   
United States, North Carolina
Ichnos Investigational Site 9 Recruiting
Durham, North Carolina, United States, 72205
Contact: Cristiana Costa Chase, MD       cristiana.costa@duke.edu   
United States, Tennessee
Ichnos Investigational Site 6 Recruiting
Nashville, Tennessee, United States, 37203
Contact: Jesus Berdeja, MD       jberdeja@tnonc.com   
Ichnos Investigational Site 8 Recruiting
Nashville, Tennessee, United States, 37232
Contact: Sanjay Mohan, MD       sanjay.mohan@vumc.org   
United States, Wisconsin
Ichnos Investigational Site 4 Withdrawn
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Ichnos Sciences SA
Glenmark Pharmaceuticals S.A.
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Responsible Party: Ichnos Sciences SA
ClinicalTrials.gov 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: June 4, 2021
Last Verified: June 2021
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