Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862012
• Other study ID #: ISB 2001-101
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: July 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
• Study type: Interventional

Clinical Trial 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).

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 parts:

• Part 1: Dose escalation

• Part 2: Dose expansion

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. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Drug:
• ISB 2001
Participants will receive escalating doses of ISB 2001
• ISB 2001
Participants will receive injection of ISB 2001 as determined in Part 1.

Locations

Country	Name	City	State
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Peter MacCallum Cancer Center	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ichnos Sciences SA

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)		Up to 18 months
Primary	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)		Up to 28 days
Secondary	Maximum Concentration (Cmax) of ISB 2001 in Serum		Up to 28 days
Secondary	Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum		Up to 28 days
Secondary	Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum		Up to 28 days
Secondary	Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum		Up to 28 days
Secondary	Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)		Baseline to 18 months
Secondary	Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)		18 months
Secondary	Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)		18 months
Secondary	Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)		18 months
Secondary	Time to Progression (TTP)		18 months
Secondary	Time to Next Treatment (TTNT)		18 months
Secondary	Time to Response (TTR)		18 months
Secondary	Progression Free Survival (PFS)		18 months
Secondary	Overall Survival (OS)		18 months