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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05427812
Other study ID # ISB 1442-101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 27, 2022
Est. completion date May 1, 2027

Study information

Verified date June 2024
Source Ichnos Sciences SA
Contact Ichnos Sciences Clinical Trials Administrator
Phone (315) 583-1249
Email clinicaltrials@ichnossciences.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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-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.


Recruitment information / eligibility

Status Recruiting
Enrollment 121
Est. completion date May 1, 2027
Est. primary completion date May 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female patients aged 18 years or older. 2. 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 3. Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients): 1. 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 ). 2. Must have measurable M-protein (serum and/or 24-hr urine, or serum free light chains). 4. Phase 2: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients) 5. Have a body weight = 40.0 kg at screening. 6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. 7. Have life expectancy of at least 3 months (from date of informed consent signing). 8. Have adequate organ function, including: 1. 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. 2. Estimated creatinine clearance =45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine collection. 9. Left ventricular ejection fraction (LVEF) =45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan. Exclusion Criteria: 1. Participants with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive). 2. Participants with MM with disease where the only measurable parameter is plasmacytoma. 3. 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-? ligand inhibitors are allowed. 4. Received autologous stem cell transplantation within 12 weeks of C1D1. 5. 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. 6. 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. 7. Active malignant central nervous system involvement 8. Known to be refractory to platelet or RBC transfusions 9. Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation. 10. QTc interval > 480 msec at screening using Fredericia's QT correction formula.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ISB 1442 SC injection escalating doses
Participants will receive escalating SC doses of ISB 1442
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

Locations

Country Name City State
Australia Pindara Private Hospital Benowa Queensland
Australia Royal Prince Albert Hospital: Institute of Haematology Camperdown New South Wales
Australia St. Vincent's Hospital Melbourne Fitzroy Victoria
Australia The Alfred Hospital-Melbourne Melbourne Victoria
Australia One Clinical Research Pty Ltd Nedlands Western Australia
Australia Gold Coast University Hospital Southport Queensland
India Health Care Global Enterprises Limited (HCG) Bangalore
India M S Ramaiah Medical College & Hospital Bangalore
India Max Super Speciality Hospital Delhi
United States The University of Chicago Medical Center (UCMC) Duchossois Center for Advanced Medicine (DCAM) Chicago Illinois
United States Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center - Main Campus Detroit Michigan
United States University of Miami - Sylvester Comprehensive Cancer Center Miami Florida
United States Froedtert Hospital & The Medical College of Wisconsin Milwaukee Wisconsin
United States New York-Presbyterian /Weill Cornell Medical Center - The Myeloma Center New York New York
United States Washington University School of Medicine - Siteman Cancer Center Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Ichnos Sciences SA

Countries where clinical trial is conducted

United States,  Australia,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) Up to 18 months
Primary Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1) Up to 28 days
Primary Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG) 18 months
Secondary Maximum Concentration (Cmax) of ISB 1442 in Serum Up to 28 days
Secondary Time to Reach Maximum Concentration (Tmax) of ISB 1442 in Serum Up to 28 days
Secondary Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum Up to 28 days
Secondary Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum Up to 28 days
Secondary Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT) Baseline to 18 months
Secondary Phase 1 and Phase 2: Time to Progression (TTP) 18 Months
Secondary Phase 1 and Phase 2: Time to Next Treatment (TTNT) 18 Months
Secondary Phase 1 and Phase 2: Time to Response (TTR) 18 Months
Secondary Phase 1 and Phase 2: Progression free survival (PFS) 18 Months
Secondary Phase 1 and Phase 2: Overall survival (OS) 18 Months
Secondary Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG) 18 months
Secondary Phase 1 and Phase 2: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG) 18 months
Secondary Phase 1 and Phase 2: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG) 18 months
Secondary Phase 2: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs) 18 months
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