search
Back to results

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

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ISB 1342
Sponsored by
Ichnos Sciences SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences (UAMS)
  • Colorado Blood Cancer Institute
  • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer CenterRecruiting
  • Mayo Clinic Cancer Center (MCCC) - RochesterRecruiting
  • Hackensack University Medical Center
  • Mount Sinai Beth IsraelRecruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • Duke Clinical Research InstituteRecruiting
  • Tennessee OncologyRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • University of Wisconsin Hospital and Clinics
  • CHU de Nantes - Hôtel-DieuRecruiting
  • CHU Hopitaux de Bordeaux - Hôpital Haut-LévêqueRecruiting
  • Centre Hospitalier Lyon-SudRecruiting
  • CHU de PoitiersRecruiting
  • CHU de Rennes - Hôpital PontchaillouRecruiting
  • Institut Universitaire du Cancer de Toulouse - OncopoleRecruiting
  • CHRU de Tours - Hôpital BretonneauRecruiting
  • CHU Hôpital Henri MondorRecruiting
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude HuriezRecruiting
  • L'Institut Paoli - CalmettesRecruiting
  • Hôpital Saint-AntoineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ISB 1342

Arm Description

Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met

Outcomes

Primary Outcome Measures

Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
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)

Secondary Outcome Measures

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)
Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)
Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)
Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2)
Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2)
Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)
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)
Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)
Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)
Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)
Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)
Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)
Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)
Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)
Efficacy of ISB 1342 (overall survival [OS]) (Part 2)
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)

Full Information

First Posted
October 4, 2017
Last Updated
May 10, 2022
Sponsor
Ichnos Sciences SA
Collaborators
Glenmark Pharmaceuticals S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT03309111
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ichnos Sciences SA
Collaborators
Glenmark Pharmaceuticals S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ISB 1342
Arm Type
Experimental
Arm Description
Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met
Intervention Type
Biological
Intervention Name(s)
ISB 1342
Intervention Description
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 Measure Information:
Title
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
Time Frame
28 days
Title
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 Measure Information:
Title
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
Title
Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)
Time Frame
28 days
Title
Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)
Time Frame
28 days
Title
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
Title
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
Title
Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)
Time Frame
28 days
Title
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
Title
Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)
Time Frame
28 days
Title
Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)
Time Frame
28 days
Title
Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)
Time Frame
28 days
Title
Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)
Time Frame
28 days
Title
Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)
Time Frame
28 days
Title
Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)
Time Frame
28 days
Title
Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)
Time Frame
28 days
Title
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.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ichnos Sciences Clinical Trials Administrator
Phone
(315) 583-1249
Email
clinicaltrials@ichnossciences.com
Facility Information:
Facility Name
University of Arkansas for Medical Sciences (UAMS)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Withdrawn
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Terminated
Facility Name
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Ann Huff, MD
Email
huffca@jhmi.edu
Facility Name
Mayo Clinic Cancer Center (MCCC) - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prashant Kapoor, MD
Email
Kapoor.Prashant@mayo.edu
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Terminated
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Richter, MD
Email
joshua.richter@mountsinai.org
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Lesokhin, MD
Email
lesokhia@mskcc.org
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiana Costa Chase, MD
Email
cristiana.costa@duke.edu
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Berdeja, MD
Email
jberdeja@tnonc.com
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Mohan, MD
Email
sanjay.mohan@vumc.org
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Withdrawn
Facility Name
CHU de Nantes - Hôtel-Dieu
City
Nantes
State/Province
Cedex
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrille Touzeau, MD
Email
cyrille.touzeau@chu-nantes.fr
Facility Name
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque
City
Pessac
State/Province
Cedex
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrille Hulin, MD
Email
cyrille.hulin@chu-bordeaux.fr
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre Benite
State/Province
Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Karlin, MD
Email
lionel.karlin@chu-lyon.fr
Facility Name
CHU de Poitiers
City
Poitiers
State/Province
Cedex
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Leleu, MD
Email
xavier.leleu@chu-poitiers.fr
Facility Name
CHU de Rennes - Hôpital Pontchaillou
City
Rennes
State/Province
Cedex
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Decaux, MD
Email
olivier.decaux@chu-rennes.fr
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
State/Province
Cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurore Perrot, MD
Email
Perrot.Aurore@iuct-oncopole.fr
Facility Name
CHRU de Tours - Hôpital Bretonneau
City
Tours
State/Province
Cedex
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Chalopin, MD
Email
t.chalopin@chu-tours.fr
Facility Name
CHU Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim Belhadj, MD
Email
karim.belhadj@aphp.fr
Facility Name
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salomon Manier, MD
Email
salomon.manier@chru-lille.fr
Facility Name
L'Institut Paoli - Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Stoppa, MD
Email
stoppaam@ipc.unicancer.fr
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Mohty, MD
Email
mohamad.mohty@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs