Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma

• ClinicalTrials.gov Identifier: NCT05862012
• Recruitment Status: Not yet recruiting
• First Posted: May 17, 2023
• Last Update Posted: May 19, 2023
• Sponsor: Ichnos Sciences SA
• Information provided by (Responsible Party): Ichnos Sciences SA

Tracking Information

• First Submitted Date: May 4, 2023
• First Posted Date: May 17, 2023
• Last Update Posted Date: May 19, 2023
• Estimated Study Start Date: May 2023
• Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2023)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 7, 2023)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Relapsed/Refractory Multiple Myeloma

Intervention

• Drug: ISB 2001
  Participants will receive escalating doses of ISB 2001
• Drug: ISB 2001
  Participants will receive injection of ISB 2001 at 2 putative recommended Phase 2 doses as determined in Part 1.

Study Arms

• 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
  Intervention: Drug: 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.
  Intervention: Drug: ISB 2001

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 7, 2023): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2027
• Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ichnos Sciences Clinical Trials Administrator; (315) 583-1249; clinicaltrials@ichnossciences.com

• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT05862012
• Other Study ID Numbers: ISB 2001-101
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ichnos Sciences SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Ichnos Sciences SA
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Ichnos Sciences SA
• Verification Date: May 2023