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Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Primary Purpose

Relapsed/Refractory Multiple Myeloma

Status
Not yet recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
ISB 2001
ISB 2001
Sponsored by
Ichnos Sciences SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring ISB 2001, Relapsed/refractory multiple myeloma, Open-label, Dose escalation, Dose expansion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pindara Private Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
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)

Secondary Outcome Measures

Maximum Concentration (Cmax) of ISB 2001 in Serum
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Time to Progression (TTP)
Time to Next Treatment (TTNT)
Time to Response (TTR)
Progression Free Survival (PFS)
Overall Survival (OS)

Full Information

First Posted
May 4, 2023
Last Updated
May 18, 2023
Sponsor
Ichnos Sciences SA
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1. Study Identification

Unique Protocol Identification Number
NCT05862012
Brief Title
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ichnos Sciences SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
ISB 2001, Relapsed/refractory multiple myeloma, Open-label, Dose escalation, Dose expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
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
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ISB 2001
Intervention Description
Participants will receive escalating doses of ISB 2001
Intervention Type
Drug
Intervention Name(s)
ISB 2001
Intervention Description
Participants will receive injection of ISB 2001 at 2 putative recommended Phase 2 doses as determined in Part 1.
Primary Outcome Measure Information:
Title
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to 18 months
Title
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 Measure Information:
Title
Maximum Concentration (Cmax) of ISB 2001 in Serum
Time Frame
Up to 28 days
Title
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Time Frame
Up to 28 days
Title
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Time Frame
Up to 28 days
Title
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Time Frame
Up to 28 days
Title
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
Title
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Time Frame
18 months
Title
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Time Frame
18 months
Title
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Time Frame
18 months
Title
Time to Progression (TTP)
Time Frame
18 months
Title
Time to Next Treatment (TTNT)
Time Frame
18 months
Title
Time to Response (TTR)
Time Frame
18 months
Title
Progression Free Survival (PFS)
Time Frame
18 months
Title
Overall Survival (OS)
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ichnos Sciences Clinical Trials Administrator
Phone
(315) 583-1249
Email
clinicaltrials@ichnossciences.com
Facility Information:
Facility Name
Pindara Private Hospital
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA
Email
drsia@fiho.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

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