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Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma

PHASE1PHASE2RECRUITING

This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).

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Study details:

The study will be conducted in two phases:. * Phase 1: Dose escalation in R/R MM. * Phase 2: Dose expansions in select R/R MM.

Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a Recommended Phase 2 Dose (RP2D) is established in Phase 1 for a given indication, Phase 2 will be initiated for that indication. Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

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Eligibility criteria

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

Inclusion criteria

  • Male or female patients aged 18 years or older.
  • Be willing and able to provide written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act of 1996 [HIPAA]) prior to any protocol related procedures, including screening evaluations
  • Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients): Must have received at least 3 prior lines of therapy, including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. (Note: Patients in Australia may have received any of the therapies including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit). Must have measurable M-protein (serum and/or 24-hr urine, or serum free light chains).
  • Phase 2: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients)
  • Have a body weight ≥ 40.0 kg at screening.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
  • Have life expectancy of at least 3 months (from date of informed consent signing).
  • Have adequate organ function, including: Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) ≤3.0 × ULN; bilirubin ≤1.5 × ULN. Patients with Gilbert's syndrome may have a bilirubin level >1.5 × ULN, per discussion between the Investigator and medical monitor. Estimated creatinine clearance ≥45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine collection.
  • Left ventricular ejection fraction (LVEF) ≥45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan.

    • Exclusion criteria

  • Participants with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
  • Participants with MM with disease where the only measurable parameter is plasmacytoma.
  • Received treatment with anti-CD38 antibodies or CD47 targeted therapies within 1 month of C1D1; systemic anticancer treatments within 14 days before the first dose of study drug (C1D1) or any investigational products within 5 half-lives of C1D1, whichever is appropriate to last therapy received. (eg, non-IMP IMiD, proteasome inhibitor could be considered to be eligible if there is at least 14 days after last dose before C1D1. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 mg/d for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand inhibitors are allowed.
  • Received autologous stem cell transplantation within 12 weeks of C1D1.
  • Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
  • Prior radiation therapy within 14 days of C1D1; or prior irradiation to > 25% of the bone marrow. Note: Prophylactic localized ('spot') radiation for areas of pain is allowed.
  • Active malignant central nervous system involvement
  • Known to be refractory to platelet or RBC transfusions
  • Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation.
  • QTc interval > 480 msec at screening using Fredericia's QT correction formula.
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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: 2022-09-27

    Primary completion: 2027-05-01

    Study completion finish: 2027-05-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT05427812

    Intervention or treatment

    DRUG: ISB 1442 SC injection escalating doses

    DRUG: ISB 1442 SC injection at RP2D

    Conditions

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

    • Condition: Relapsed/Refractory Multiple Myeloma

    • DRUG: ISB 1442 SC injection escalating doses and other drugs

    • Benowa, Queensland, 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:

    Pindara Private Hospital

    Research sites nearby

    Select from list below to view details:

    • Pindara Private Hospital

      Benowa, Queensland, Australia

    • St. Vincent's Hospital Melbourne

      Fitzroy, Victoria, Australia

    • Royal Prince Albert Hospital: Institute of Haematology

      Camperdown, New South Wales, Australia

    • Gold Coast University Hospital

      Southport, 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: Phase 1: Dose escalation
    • Participants with R/R multiple myeloma (MM) will be administered ISB 1442 weekly by subcutaneous (SC) injection in each 28-day cycle. Dose escalation will begin with an accelerated titration dose escalation and should certain conversion criteria be met, escalation will convert to the standard (3 + 3) dose escalation
    DRUG: ISB 1442 SC injection escalating doses
    • Participants will receive escalating SC doses of ISB 1442
    EXPERIMENTAL: Phase 2 (Dose Expansion): R/R Multiple Myeloma
    • This cohort includes the participants with pathologically confirmed R/R MM and must have received at least 3 prior lines of therapy, including proteasome inhibitors (PIs), immunomodulators (IMiDs), and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. Participants will receive the recommended Phase 2 Dose (RP2D) of ISB 1442 SC injection determined in Phase 1 of the study for treatment of R/R MM. Each treatment cycle duration is 28 days. The anticipated total duration for each participant will vary, depending on the number of cycles of treatment completed. The treatment phase will extend until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met.
    DRUG: ISB 1442 SC injection at RP2D
    • ISB 1442 SC injection dose regimen at RP2D until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)Not SpecifiedUp to 18 months
    Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1)Not SpecifiedUp to 28 days
    Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)Not Specified18 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Maximum Concentration (Cmax) of ISB 1442 in SerumNot SpecifiedUp to 28 days
    Time to Reach Maximum Concentration (Tmax) of ISB 1442 in SerumNot SpecifiedUp to 28 days
    Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in SerumNot SpecifiedUp to 28 days
    Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in SerumNot SpecifiedUp to 28 days
    Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT)Not SpecifiedBaseline to 18 months
    Phase 1 and Phase 2: Time to Progression (TTP)Not Specified18 Months
    Phase 1 and Phase 2: Time to Next Treatment (TTNT)Not Specified18 Months
    Phase 1 and Phase 2: Time to Response (TTR)Not Specified18 Months
    Phase 1 and Phase 2: Progression free survival (PFS)Not Specified18 Months
    Phase 1 and Phase 2: Overall survival (OS)Not Specified18 Months
    Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)Not Specified18 months
    Phase 1 and Phase 2: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)Not Specified18 months
    Phase 1 and Phase 2: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)Not Specified18 months
    Phase 2: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs)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: Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma

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