This is a two-stage phase 1b/2a, open-label, multicenter, dose-escalation study of STI-6129 administered intravenously once in a 4-week cycle in subjects with relapsed or refractory multiple myeloma.
This is a two-stage phase 1b/2a, open-label, multicenter, dose-escalation study of STI-6129 administered intravenously once in a 4-week cycle in subjects with relapsed or refractory multiple myeloma. The study is designed to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics using a conventional 3+3 study design for dose escalation in stage one and then the second stage will be an expansion study to assess preliminary efficacy. Patients will be enrolled sequentially within each cohort and between cohorts during the dose escalation portion of the study with a 28-day cycle of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor
NYU Lagone Health
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Safety of STI-6129
Safety as assessed by incidence of adverse events (AEs), severe AEs (SAEs), DLTs, neurotoxicity and laboratory abnormalities using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)
Time frame: Baseline through study completion at up to approximately 24 months
Measuring Pharmacokinetic [PK] Profile
STI-6129 blood plasma concentrations will be measured for the total antibody plus conjugated toxin (STI 6129) and the free toxin
Time frame: Baseline through study completion at up to approximately 24 months
Overall response and duration
Response and duration determined according to the International Myeloma Working Group (IMWG) response criteria
Time frame: Baseline through study completion at up to approximately 24 months
Assess preliminary efficacy
As a measure of activity, overall response rate will be assessed according to the modified International Myeloma Working Group (IMWG) criteria.
Time frame: Baseline through study completion at up to approximately 24 months
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