Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
ISB 1342-101
- SECONDARY ID:
2016-005253-20
- NCT ID:
NCT03309111
Conditions
- Relapsed/Refractory Multiple Myeloma
Interventions
| Drug | Synonyms | Arms |
|---|
| ISB 1342 | | ISB 1342 |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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 | |
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1) |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | 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 |
| Safety Issue: | |
| Description: | |
| Measure: | Maximum serum concentration (Cmax) of ISB 1342 |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
| Measure: | Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
| Measure: | Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
| Measure: | Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
| Measure: | Efficacy of ISB 1342 (duration of response [DOR]) (Part 2) |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
| Measure: | Efficacy of ISB 1342 (disease control rate [DCR]) (Part 2) |
| Time Frame: | 28 days |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Ichnos Sciences SA |
Last Updated
June 4, 2021
