The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05862012
Recruitment Status : Not yet recruiting
First Posted : May 17, 2023
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Ichnos Sciences SA

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Drug: ISB 2001 Phase 1

Detailed Description:

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 phases:

  • Part 1: Dose escalation phase
  • Part 2: Dose expansion phase

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 at each putative recommended Phase 2 dose(s). Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma
Estimated Study Start Date : May 2023
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/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 at each putative recommended Phase 2 dose(s). 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 at 2 putative recommended Phase 2 doses as determined in Part 1.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 18 months ]
  2. 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) [ Time Frame: Up to 28 days ]

Secondary Outcome Measures :
  1. Maximum Concentration (Cmax) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
  2. Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
  3. Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
  4. Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
  5. Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT) [ Time Frame: Baseline to 18 months ]
  6. Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG) [ Time Frame: 18 months ]
  7. Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG) [ Time Frame: 18 months ]
  8. Duration of Response (DOR) Based on International Myeloma Working Group (IMWG) [ Time Frame: 18 months ]
  9. Time to Progression (TTP) [ Time Frame: 18 months ]
  10. Time to Next Treatment (TTNT) [ Time Frame: 18 months ]
  11. Time to Response (TTR) [ Time Frame: 18 months ]
  12. Progression Free Survival (PFS) [ Time Frame: 18 months ]
  13. Overall Survival (OS) [ Time Frame: 18 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
  2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
  3. Must have adequate hematologic, hepatic, renal, and cardiac functions

Exclusion Criteria:

  1. Active malignant central nervous system involvement
  2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
  3. History of autoimmune disease requiring systemic immunosuppressive therapy
  4. 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.
  5. 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05862012


Contacts
Layout table for location contacts
Contact: Ichnos Sciences Clinical Trials Administrator (315) 583-1249 clinicaltrials@ichnossciences.com

Locations
Layout table for location information
Australia, Queensland
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Contact: Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA       drsia@fiho.com.au   
Sponsors and Collaborators
Ichnos Sciences SA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ichnos Sciences SA
ClinicalTrials.gov Identifier: NCT05862012    
Other Study ID Numbers: ISB 2001-101
First Posted: May 17, 2023    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ichnos Sciences SA:
ISB 2001
Relapsed/refractory multiple myeloma
Open-label
Dose escalation
Dose expansion
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases