Etude : ISB 1342-101 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : ISB 1342-101

Situation thérapeutique : Induction

Traitement : Immunothérapie

Cadre réglementaire : RIPH1

Dernière MÀJ : 29/11/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : 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

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

SINGLE ARM:
Experimental: ISB 1342 - ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion
Part 1: Cohorts of multiple ISB 1342 dose levels;
Part 2: One dose regimen until disease progression or other discontinuation criterion is met

CURRENT PRIMARY OUTCOMES:
- Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1) [ Time Frame: 28 days ]
- Investigator-assessed objective response (complete response [CR], stringent CR [sCR], partial response [PR], very good PR [VGPR], minimal response [MR]) to ISB 1342, according to international myeloma working group (IMWG) criteria (Part 2) [ Time Frame: 28 days ]

CURRENT SECONDARY OUTCOMES:
- Number of subjects with adverse events based on relatedness and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 [ Time Frame: up to 30 days post last dose ]
- Maximum serum concentration (Cmax) of ISB 1342 [ Time Frame: 28 days ]
- Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 [ Time Frame: 28 days ]
- Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 [ Time Frame: 28 days ]
- Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 [ Time Frame: 28 days ]
- Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (duration of response [DOR]) (Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (disease control rate [DCR]) (Part 2) [ Time Frame: 28 days ]

Phase : I

Stade : NA

Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Documented diagnosis of relapsed/refractory multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria
- Patients have received proteasome inhibitor, immunomodulator, and daratumumab
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less
- Adequate hematologic, renal, and hepatic functions

Critères de non-inclusion : - Active central nervous system involvement
- Exposure to daratumumab within 6 months prior to the start of study treatment
- Active plasma cell leukemia
- Blood transfusion and/or granulocyte-(macrophage) colony-stimulating factor
- Active infectious disease
- Clinically significant cardiovascular and respiratory conditions
- History of HIV infection or acute or chronic active hepatitis B or C infection
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03309111
Promoteur :
Ichnos Sciences
Type de sponsor : Institutionnel
Paramus, New Jersey, USA - USA
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Salomon Manier

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 12/10/2021