Clinical Trials /

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

NCT03309111

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GBR 1342-101
  • SECONDARY ID: 2016-005253-20
  • SECONDARY ID: GBR 1342-101
  • NCT ID: NCT03309111

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
ISB 1342ISB 1342

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
ISB 1342ExperimentalOpen-label dose escalation of ISB 1342
  • ISB 1342

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximal Tolerated Dose (MTD) of ISB 1342 (Part 1)
Time Frame:28 days
Safety Issue:
Description: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

Secondary Outcome Measures

Measure:Maximum serum concentration (Cmax) of ISB 1342
Time Frame:28 days
Safety Issue:
Description:
Measure:Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342
Time Frame:28 days
Safety Issue:
Description:
Measure:Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation assessed from baseline until end of treatment
Time Frame:28 days
Safety Issue:
Description:
Measure:Anti-tumor activity of ISB 1342 (Disease control rate)
Time Frame:28 days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Ichnos Sciences SA

Trial Keywords

  • ISB 1342 CD38/CD3 Bispecific Antibody
  • ISB 1342 in Previously Treated Multiple Myeloma

Last Updated

January 10, 2020