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A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma


Description

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 will enroll 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 will be conducted in two parts: * Part 1: Dose escalation * Part 2: Dose expansion Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treat

Trial Eligibility

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.

Study Info

Organization

Ichnos Sciences SA


Primary Outcome

Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)


Outcome Timeframe Up to 18 months

NCTID NCT05862012

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2023-11-01

Completion Date 2027-07

Enrollment Target 80

Interventions

DRUG ISB 2001

DRUG ISB 2001

Locations Recruiting

Montefiore Medical Center

United States, New York, Bronx


University of North Carolina

United States, North Carolina, Chapel Hill


Pindara Private Hospital

Australia, Queensland, Benowa


St. Vincent's Hospital Melbourne

Australia, Victoria, Fitzroy


Peter MacCallum Cancer Center

Australia, Victoria, Melbourne


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