This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).
The study enrolls participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM. The study is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion. Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 18 months
Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)
Time frame: Up to 28 days
Maximum Concentration (Cmax) of ISB 2001 in Serum
Time frame: Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Time frame: Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Time frame: Up to 28 days
Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)
Time frame: Baseline to 18 months
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Time frame: 18 months
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Miami, Florida, United States
ACTIVE_NOT_RECRUITINGWinship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGUniversity of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGTennessee Oncology
Nashville, Tennessee, United States
ACTIVE_NOT_RECRUITINGVirginia Commonwealth University (VCU)
Richmond, Virginia, United States
ACTIVE_NOT_RECRUITINGFroedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING...and 22 more locations
Time to Progression (TTP)
Time frame: 18 months
Time to Next Treatment (TTNT)
Time frame: 18 months
Time to Response (TTR)
Time frame: 18 months
Progression Free Survival (PFS)
Time frame: 18 months
Overall Survival (OS)
Time frame: 18 months