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Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

PHASE1RECRUITING

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).

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Study details:

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 treatment, or participant withdrawal from the study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

    • 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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-11-01

    Primary completion: 2027-07-01

    Study completion finish: 2027-07-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT05862012

    Intervention or treatment

    DRUG: ISB 2001

    DRUG: ISB 2001

    Conditions

    • • Relapsed/Refractory Multiple Myeloma
    Image related to Relapsed/Refractory Multiple Myeloma

    • Condition: Relapsed/Refractory Multiple Myeloma

    • DRUG: ISB 2001 and other drugs

    • Fitzroy, Victoria, Australia and more

    • Sponsor: Ichnos Sciences SA

    You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

    Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

    Find a site

    Closest Location:

    St. Vincent's Hospital Melbourne

    Research sites nearby

    Select from list below to view details:

    • St. Vincent's Hospital Melbourne

      Fitzroy, Victoria, Australia

    • Peter MacCallum Cancer Center

      Melbourne, Victoria, Australia

    • Linear Clinical Research

      Nedlands, Western Australia, Australia

    • Pindara Private Hospital

      Benowa, Queensland, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Part 1: Dose Escalation
    • Participants with R/R MM will be administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study
    DRUG: ISB 2001
    • Participants will receive escalating doses of ISB 2001
    EXPERIMENTAL: Part 2: Dose Expansion
    • 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 treatment or participant withdrawal from the study.
    DRUG: ISB 2001
    • Participants will receive injection of ISB 2001 as determined in Part 1.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)Not SpecifiedUp 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)Not SpecifiedUp to 28 days

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Maximum Concentration (Cmax) of ISB 2001 in SerumNot SpecifiedUp to 28 days
    Time to Reach Maximum Concentration (Tmax) of ISB 2001 in SerumNot SpecifiedUp to 28 days
    Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in SerumNot SpecifiedUp to 28 days
    Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in SerumNot SpecifiedUp to 28 days
    Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)Not SpecifiedBaseline to 18 months
    Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)Not Specified18 months
    Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)Not Specified18 months
    Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)Not Specified18 months
    Time to Progression (TTP)Not Specified18 months
    Time to Next Treatment (TTNT)Not Specified18 months
    Time to Response (TTR)Not Specified18 months
    Progression Free Survival (PFS)Not Specified18 months
    Overall Survival (OS)Not Specified18 months

    Frequently Asked Questions

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    You may be eligible to participate in this trial based on your search.Apply for study
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    References

    Clinical Trials Gov: Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

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