Status:
TERMINATED
Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Ichnos Sciences SA
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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).
Detailed Description
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-es...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2024
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05427812
Start Date
September 27 2022
End Date
November 19 2024
Last Update
January 17 2025
Active Locations (15)
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1
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
2
The University of Chicago Medical Center (UCMC) Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, United States, 60637
3
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus
Detroit, Michigan, United States, 48201
4
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110