InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.Learn why

Optimise reading forHealth ProfessionalsPatients

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

Use the hyperlinks, where available to access additional clinical trial information.

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.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Cancer Connect

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Get support

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

More info for carers

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

HelpThis verification step helps prevent fraudulent transactions from automated software.
Submitting ... Please wait

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.