Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT05862012 |
Recruitment Status :
Not yet recruiting
First Posted : May 17, 2023
Last Update Posted : May 19, 2023
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Condition or disease | Intervention/treatment | Phase |
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Relapsed/Refractory Multiple Myeloma | Drug: ISB 2001 | Phase 1 |
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 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 |
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
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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. |
- Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 18 months ]
- 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 ]
- Maximum Concentration (Cmax) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
- Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
- Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
- Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum [ Time Frame: Up to 28 days ]
- 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 ]
- Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG) [ Time Frame: 18 months ]
- Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG) [ Time Frame: 18 months ]
- Duration of Response (DOR) Based on International Myeloma Working Group (IMWG) [ Time Frame: 18 months ]
- Time to Progression (TTP) [ Time Frame: 18 months ]
- Time to Next Treatment (TTNT) [ Time Frame: 18 months ]
- Time to Response (TTR) [ Time Frame: 18 months ]
- Progression Free Survival (PFS) [ Time Frame: 18 months ]
- Overall Survival (OS) [ Time Frame: 18 months ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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
Contact: Ichnos Sciences Clinical Trials Administrator | (315) 583-1249 | clinicaltrials@ichnossciences.com |
Australia, Queensland | |
Pindara Private Hospital | |
Benowa, Queensland, Australia, 4217 | |
Contact: Hanlon Sia, MBBS(Adelaide), FRACP, FRCPA drsia@fiho.com.au |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ISB 2001 Relapsed/refractory multiple myeloma Open-label Dose escalation Dose expansion |
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 |