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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-005253-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Glenmark Pharmaceuticals S.A. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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) | up to 30 days post last dose | |
| Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States | ||
| Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center |
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| 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 |
| Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2) | 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) | 28 days |
| Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2) | 28 days |
| Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2) | 28 days |
| Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2) | 28 days |
| Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2) | 28 days |
| Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2) | 28 days |
| Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2) | 28 days |
| Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2) | 28 days |
| Efficacy of ISB 1342 (overall survival [OS]) (Part 2) | 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) | 28 days |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Mayo Clinic Cancer Center (MCCC) - Rochester | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai Beth Israel | New York | New York | 10029 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke Clinical Research Institute | Durham | North Carolina | 72205 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| CHU de Nantes - Hôtel-Dieu | Nantes | Cedex | 44093 | France |
| CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque | Pessac | Cedex | 33604 | France |
| Centre Hospitalier Lyon-Sud | Pierre-Bénite | Cedex | 69495 | France |
| CHU de Poitiers | Poitiers | Cedex | 86021 | France |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | Cedex | 35033 | France |
| Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | Cedex | France |
| CHRU de Tours - Hôpital Bretonneau | Tours | Cedex | 37044 | France |
| CHU Hôpital Henri Mondor | Créteil | 94010 | France |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Lille | 59000 | France |
| L'Institut Paoli - Calmettes | Marseille | 13009 | France |
| Hôpital Saint-Antoine | Paris | 75012 | France |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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