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

NCT03309111 | Completed Phase 1 FDA Drug

• 2 other identifiers: ISB 1342-1012016-005253-20
• Study Type: interventional
• Target: 81
• Locations: 2 countries
• Sites: 20

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

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

  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)

  28 days

Secondary Outcomes (16)

• 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)

  up to 30 days post last dose

• Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)

  28 days

• Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)

  28 days

• Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2)

  28 days

• Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2)

  28 days

Study Arms (1)

ISB 1342

EXPERIMENTAL

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

Interventions

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)

ISB 1342

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ichnos Sciences SA: lead
• Glenmark Pharmaceuticals S.A.: collaborator

Study Sites (20)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic Cancer Center (MCCC) - Rochester

Rochester, Minnesota, 55905, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Mount Sinai Beth Israel

New York, New York, 10029, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke Clinical Research Institute

Durham, North Carolina, 72205, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

CHU de Nantes - Hôtel-Dieu

Nantes, Cedex, 44093, France

Location

CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

Pessac, Cedex, 33604, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, Cedex, 69495, France

Location

CHU de Poitiers

Poitiers, Cedex, 86021, France

Location

CHU de Rennes - Hôpital Pontchaillou

Rennes, Cedex, 35033, France

Location

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, Cedex, France

Location

CHRU de Tours - Hôpital Bretonneau

Tours, Cedex, 37044, France

Location

CHU Hôpital Henri Mondor

Créteil, 94010, France

Location

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

Lille, 59000, France

Location

L'Institut Paoli - Calmettes

Marseille, 13009, France

Location

Hôpital Saint-Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 13, 2017
• Study Start: October 25, 2017
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); FR (11)