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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

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE October 25, 2017
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1) [ Time Frame: 28 days ]
  • 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 ]
Original 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • 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 ]
  • Maximum serum concentration (Cmax) of ISB 1342 [ Time Frame: 28 days ]
  • Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 [ Time Frame: 28 days ]
  • Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 [ Time Frame: 28 days ]
  • Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 [ Time Frame: 28 days ]
  • Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation [ Time Frame: 28 days ]
  • Efficacy of ISB 1342 (duration of response [DOR]) (Part 2) [ Time Frame: 28 days ]
  • Efficacy of ISB 1342 (disease control rate [DCR]) (Part 2) [ Time Frame: 28 days ]
Original 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Multiple Myeloma
Intervention  ICMJE Biological: ISB 1342
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion
Study Arms  ICMJE 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
Intervention: Biological: ISB 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: June 1, 2021)
197
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
125
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Sciences Clinical Trials Administrator (315) 583-1249 clinicaltrials@ichnossciences.com
Listed Location Countries  ICMJE United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03309111
Other Study ID Numbers  ICMJE ISB 1342-101
2016-005253-20 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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 Not Provided
PRS Account Ichnos Sciences SA
Verification Date June 2021

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