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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.
 
ClinicalTrials.gov Identifier: NCT03309111
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : May 16, 2022
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 : 245 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 or subcutaneous injection (SC)




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. Proportion of subjects with an investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 2) [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events based on frequency and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 (Part 1 and Part 2) [ Time Frame: up to 30 days post last dose ]
  2. Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
  3. Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
  4. Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
  5. Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
  6. Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2) [ Time Frame: 28 days ]
  7. Percent incidence of neutralizing antibody formation from positive anti-drug antibody (ADA) samples assessed from baseline until end of treatment (EOT) (Part 1 and Part 2) [ Time Frame: 28 days ]
  8. Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2) [ Time Frame: 28 days ]
  9. Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2) [ Time Frame: 28 days ]
  10. Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2) [ Time Frame: 28 days ]
  11. Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2) [ Time Frame: 28 days ]
  12. Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2) [ Time Frame: 28 days ]
  13. Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2) [ Time Frame: 28 days ]
  14. Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2) [ Time Frame: 28 days ]
  15. Efficacy of ISB 1342 (overall survival [OS]) (Part 2) [ Time Frame: Time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months. ]
  16. Proportion of subjects with investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 1) [ 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
Criteria

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
  • Adequate hematologic, renal, and hepatic functions
  • Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
  • Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
  • Oxygen saturation level ≥92% on room air.
  • Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening

Exclusion Criteria:

  • Active central nervous system involvement
  • Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
  • Active plasma cell leukemia
  • Active infectious disease
  • Clinically significant cardiovascular and respiratory conditions
  • History of HIV infection
  • Subjects requiring prohibited concomitant medications

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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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: May 16, 2022
Last Verified: May 2022
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