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

May 10, 2022 updated by: Ichnos Sciences SA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

245

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
      • Lille, France, 59000
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
        • Contact:
      • Marseille, France, 13009
      • Paris, France, 75012
    • Cedex
      • Nantes, Cedex, France, 44093
      • Pessac, Cedex, France, 33604
      • Pierre Benite, Cedex, France, 69495
        • Recruiting
        • Centre Hospitalier Lyon-Sud
      • Poitiers, Cedex, France, 86021
        • Recruiting
        • CHU de Poitiers
      • Rennes, Cedex, France, 35033
      • Toulouse, Cedex, France
      • Tours, Cedex, France, 37044
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Withdrawn
        • University of Arkansas for Medical Sciences (UAMS)
    • Colorado
      • Denver, Colorado, United States, 80218
        • Terminated
        • Colorado Blood Cancer Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Terminated
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Beth Israel
    • North Carolina
      • Durham, North Carolina, United States, 72205
    • Tennessee
      • Nashville, Tennessee, United States, 37232
      • Nashville, Tennessee, United States, 37203
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Withdrawn
        • University of Wisconsin Hospital and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
Time Frame: 28 days
28 days
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
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 30 days post last dose
Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)
Time Frame: 28 days
28 days
Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)
Time Frame: 28 days
28 days
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
28 days
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
28 days
Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)
Time Frame: 28 days
28 days
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
28 days
Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)
Time Frame: 28 days
28 days
Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)
Time Frame: 28 days
28 days
Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)
Time Frame: 28 days
28 days
Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)
Time Frame: 28 days
28 days
Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)
Time Frame: 28 days
28 days
Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)
Time Frame: 28 days
28 days
Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)
Time Frame: 28 days
28 days
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.
Time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months.
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ichnos Sciences SA

Collaborators

Glenmark Pharmaceuticals S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISB 1342-101
  • 2016-005253-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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