Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

Phase 1

Recruiting

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Drug: ISB 2001

• Registration Number: NCT05862012
• Lead Sponsor: Ichnos Sciences SA

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 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.

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-07
• Study First Posted: 2023-05-17
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 2: Dose Expansion	ISB 2001	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.
Part 1: Dose Escalation	ISB 2001	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

Primary Outcome Measures

Name	Time	Method
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
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)	Up to 18 months

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum	Up to 28 days
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)	18 months
Time to Next Treatment (TTNT)	18 months
Overall Survival (OS)	18 months
Time to Progression (TTP)	18 months
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum	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)	Baseline to 18 months
Maximum Concentration (Cmax) of ISB 2001 in Serum	Up to 28 days
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum	Up to 28 days
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)	18 months
Time to Response (TTR)	18 months
Progression Free Survival (PFS)	18 months
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)	18 months

Trial Locations

Locations (9)

Standford Cancer Institute; 🇺🇸 Palo Alto, California, United States

Concord Hospital; 🇦🇺 Concord, New South Wales, Australia

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

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, Australia

HCG Hospital; 🇮🇳 Bangalore, India