Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
ISB 2001, Relapsed/refractory multiple myeloma, Open-label, Dose escalation, Dose expansion
Brief summary
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).
Detailed description
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.
Interventions
DRUGISB 2001
Participants receive escalating doses of ISB 2001
Sponsors
Ichnos Sciences SA
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less 3. Must have adequate hematologic, hepatic, renal, and cardiac functions
Exclusion criteria
1. Active malignant central nervous system involvement 2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1 3. History of autoimmune disease requiring systemic immunosuppressive therapy 4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study. 5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) | 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) | Up to 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) of ISB 2001 in Serum | Up to 28 days |
| Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum | Up to 28 days |
| Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum | Up to 28 days |
| Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum | 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) | Baseline to 18 months |
| Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG) | 18 months |
| Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG) | 18 months |
| Duration of Response (DOR) Based on International Myeloma Working Group (IMWG) | 18 months |
| Time to Progression (TTP) | 18 months |
| Time to Next Treatment (TTNT) | 18 months |
| Time to Response (TTR) | 18 months |
| Progression Free Survival (PFS) | 18 months |
| Overall Survival (OS) | 18 months |
Countries
Australia, France, India, Italy, Norway, Spain, United States
Contacts
CONTACTIchnos Sciences Clinical Trials Administrator
Outcome results
None listed