This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).
The study will be conducted in two phases: * Phase 1: Dose escalation in R/R MM * Phase 2: Dose expansions in select R/R MM Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a Recommended Phase 2 Dose (RP2D) is established in Phase 1 for a given indication, Phase 2 will be initiated for that indication. Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Participants will receive escalating SC doses of ISB 1442
ISB 1442 SC injection dose regimen at RP2D until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
The University of Chicago Medical Center (UCMC) Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, United States
Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 18 months
Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1)
Time frame: Up to 28 days
Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Maximum Concentration (Cmax) of ISB 1442 in Serum
Time frame: Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 1442 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum
Time frame: Up to 28 days
Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT)
Time frame: Baseline to 18 months
Phase 1 and Phase 2: Time to Progression (TTP)
Time frame: 18 Months
Phase 1 and Phase 2: Time to Next Treatment (TTNT)
Time frame: 18 Months
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Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus
Detroit, Michigan, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
New York-Presbyterian /Weill Cornell Medical Center - The Myeloma Center
New York, New York, United States
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Prince Albert Hospital: Institute of Haematology
Camperdown, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
...and 5 more locations
Phase 1 and Phase 2: Time to Response (TTR)
Time frame: 18 Months
Phase 1 and Phase 2: Progression free survival (PFS)
Time frame: 18 Months
Phase 1 and Phase 2: Overall survival (OS)
Time frame: 18 Months
Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Phase 1 and Phase 2: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Phase 1 and Phase 2: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Phase 2: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: 18 months