Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862012
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-05-04
Brief Title:
Study of ISB 2001 in RelapsedRefractory Multiple Myeloma
Sponsor:
Ichnos Sciences SA
Organization:
Ichnos Sciences SA
Study Overview
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 RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 relapsedrefractory multiple myeloma RR MM
Detailed Description:
The study will enroll participants with RR 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 parts
Part 1 Dose escalation
Part 2 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 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
The study will be conducted in two parts
Part 1 Dose escalation
Part 2 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None