ISB 2001 for Multiple Myeloma

Recruiting at 8 trial locations

Overseen By Ichnos Sciences Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ichnos Sciences SA

Disqualifiers: CNS involvement, Uncontrolled infection, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Eligibility Criteria

This trial is for people with relapsed/refractory multiple myeloma, meaning their cancer has returned or didn't respond to treatment. They must have measurable signs of the disease and be in relatively good physical condition (ECOG score ≤2). Participants need proper blood, liver, kidney, and heart function to join.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

My blood, liver, kidney, and heart are functioning well.

My multiple myeloma is confirmed and measurable by specific tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

28 days per cycle

Weekly visits

Dose Expansion

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.

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ISB 2001

Trial Overview The study tests ISB 2001's safety and effectiveness against multiple myeloma that's come back or is resistant to other treatments. It's a Phase 1 trial, which means it’s the first time this drug is being tried in humans to see how well it works and what doses are safe.

Participant Groups

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

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.

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ichnos Sciences SA

Lead Sponsor

Trials

7

Recruited

750+