Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

PHASE1RECRUITING

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).

Study details:

The study enrolls 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 is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion. Dose escalation continued until the maximum planned dose was reached.

Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
Must have adequate hematologic, hepatic, renal, and cardiac functions

Exclusion criteria

Active malignant central nervous system involvement
Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
History of autoimmune disease requiring systemic immunosuppressive therapy
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.
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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1

Study ID

NCT05862012

Intervention or treatment

DRUG: ISB 2001

Conditions

Relapsed/Refractory Multiple Myeloma

Condition: Relapsed/Refractory Multiple Myeloma
DRUG: ISB 2001 and other drugs
Concord, New South Wales, Australia and more
Sponsor: Ichnos Sciences SA

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Are you running this trial?

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Research sites nearby

Closest Location:

Concord Hospital

Select from list below to view details:

Concord Hospital
Concord, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia

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Who is running the clinical trial?

ISS

Ichnos Sciences SA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part 1: Dose Escalation Participants with R/R MM is 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	Drug: ISB 2001
EXPERIMENTAL: Part 2: Dose Expansion Dose expansion cohorts are 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.	Drug: ISB 2001

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Part 1: Dose Escalation

Participants with R/R MM is 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

Drug: ISB 2001

EXPERIMENTAL: Part 2: Dose Expansion

Dose expansion cohorts are 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.