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Completed

NCT Number: NCT03309111

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

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.

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Key information

Conditions

Relapsed/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Nantes - Hôtel-Dieu, Nantes, Cedex, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISB 1342

Biological

ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ichnos Sciences SA

Industry

Collaborators

  • Glenmark Pharmaceuticals S.A.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2017
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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