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RecruitingLast updated: 8 January 2024

This study aims to determine the safety and recommended dosage level of a new drug, called ISB 2001) in people with relapsed/refractory multiple myelomaA 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 summary

Summary

This study will enrol people with relapsed/refractory (R/R) multiple myeloma (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: Dose Escalation and 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. In thise phase, people 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 set-up dose in Cycle 1 on Day 4. 

Dose Expansion cohorts will be initiated to further confirm safety and optimal biologically active dose at each putative recommended Phase 2 dose(s). 

Conditions

This trial is treating patients with relapsed/refractory multiple myeloma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Ichnos Sciences SA

Scientific 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

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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