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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC)
Colorado Blood Cancer Institute
Denver, Colorado, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1)
Time frame: 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)
Time frame: 28 days
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
Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2)
Time frame: 28 days
Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2)
Time frame: 28 days
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
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
Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2)
Time frame: 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)
Time frame: 28 days
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Baltimore, Maryland, United States
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Duke Clinical Research Institute
Durham, North Carolina, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
CHU de Nantes - Hôtel-Dieu
Nantes, Cedex, France
...and 10 more locations
Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2)
Time frame: 28 days
Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2)
Time frame: 28 days
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.
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