Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: ISB 2001: Dosage Form: Lyophilized powder for solution for injection
Unit Strength: Each vial delivers 77 mg of ISB 2001
Dosage Frequency:
Cycle 1: Step-up doses on Days 1 and 4 in Cyc
Sponsors
Ichnos Sciences SA
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
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
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 |
|---|---|
| 1. Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) 2. 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)Timepoint: 1. [Time Frame: Up to 18 months] 2. [Time Frame: Up to 28 days] | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration (Cmax) of ISB 2001 in SerumTimepoint: [Time Frame: Up to 28 days];Time to Reach Maximum Concentration (Tmax) of ISB 2001 in SerumTimepoint: [Time Frame: Up to 28 days];Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in SerumTimepoint: [Time Frame: Up to 28 days];Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in SerumTimepoint: [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)Timepoint: [Time Frame: Baseline to 18 months];Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)Timepoint: [Time Frame: 18 months];Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)Timepoint: [Time Frame: 18 months];Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)Timepoint: [Time Frame: 18 months];Time to Progression (TTP)Timepoint: [Time Frame: 18 months];Time to Next Treatment (TTNT)Timepoint: [Time Frame: 18 months];Time to Response (TTR)Timepoint: [Time Frame: 18 months];Progression Free Survival (PFS)Timepoint: [Time Frame: 18 months];Overall Survival (OS)Timepoint: [Time Frame: 18 months] | — |
Countries
Australia, India, United States of America
Contacts
Public ContactJatin Kadam
Glenmark Pharmaceuticals Ltd
Outcome results
None listed