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

Study Identifier:
ISB 2001-101
CT.gov Identifier:
NCT05862012
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-507071-21-01
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To evaluate ISB 2001 in Patients with Multiple Myeloma.

To evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

To assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ISB 2001 in relapsed/refractory multiple myeloma (RRMM) patients.

To assess Safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ISB2001 in RRMM patients

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Multiple Myeloma
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Part 1: Dose Escalation
    • Read More
  • Drug: Experimental: Part 2: Dose Expansion
  • Drug: ASH 2023:
  • Drug: ChiCTR:
  • Drug: ASH 2024:
  • Drug: ISB 2001 was administered weekly subcutaneously (SC) in 28-day cycles, with initial step-up doses on Days 1 (15µg/kg) and 4 (variable). DLTs were evaluated in the first 28 days. After DE, the study will proceed with Part 2 (dose expansion) to confirm safety and select the recommended Ph2 dose under FDA Project Optimus.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
    • Must have adequate hematologic, hepatic, renal, and cardiac functions
    • ASH 2023:
    • This study will enroll subjects treated with prior IMiDs, PIs, and anti-CD38 therapies, or intolerant of, established therapies known to provide benefit (prior BCMA therapies, or prior transplantation and cellular therapies allowed).be conducted in two parts (Part 1: Dose escalation and Part 2: Dose expansion) (Figure 1). Criteria for enrollment in this study include patients with RRMM with measurable disease who have been treated with an anti-CD38 antibody, IMiDs, PIs either in combination or as a single agent, and /or intolerant of established therapies known to provide clinical benefit.
    • This study is enrolling pts who have received immunomodulatory drugs, 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. Prior BCMA targeted and/or T-cell directed therapies were allowed.
    • Patients with prior CAR-T cell therapies, bispecifics and/or prior BCMA targeted agents were eligible.
    • Patients (pts) exposed to immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapies and refractory or intolerant to established therapies. Prior BCMA-targeted and/or T-cell directed therapies were allowed.
    Exclusion criteria
    • Active malignant central nervous system involvement
    • Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
    • History of autoimmune disease requiring systemic immunosuppressive therapy
    • 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.
    • 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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Gala Vega Achabal
    Status
    Recruiting
    Condition(s) Treated at Site
    Multiple Myeloma
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Damian Cubillas
    Status
    Recruiting
    Condition(s) Treated at Site
    Multiple Myeloma