Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630806
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With RelapsedRefractory Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-human Open-label Phase 1 Study to Evaluate the Safety Antitumor Activity Pharmacokinetics and Pharmacodynamics of Subcutaneous SAR446523 an Anti-GPRC5D ADCC-enhanced Monoclonal Antibody in Participants With RelapsedRefractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human study of SAR446523 conducted in patients with RRMM
The study consists of two parts
Dose escalation Part A In this part up to 6 dose levels DLs of SAR446523 will be explored to determine the maximum administered dose MAD maximum tolerated dose MTD and recommended dose range RDR of 2 dose regimens which will be tested in the dose optimization part
Dose optimization Part B In this part participants will be randomly assigned in a 11 ratio using interactive response technology IRT to either one of the chosen dose regimens of SAR446523 determined from data coming from Part A to determine the optimal dose as the recommended phase 2 dose RP2D of SAR446523
The study consists of two parts
Dose escalation Part A In this part up to 6 dose levels DLs of SAR446523 will be explored to determine the maximum administered dose MAD maximum tolerated dose MTD and recommended dose range RDR of 2 dose regimens which will be tested in the dose optimization part
Dose optimization Part B In this part participants will be randomly assigned in a 11 ratio using interactive response technology IRT to either one of the chosen dose regimens of SAR446523 determined from data coming from Part A to determine the optimal dose as the recommended phase 2 dose RP2D of SAR446523
Detailed Description:
The study will be considered ongoing until the last participant last visit has occurred Participants will be allowed to continue therapy until disease progression unacceptable AEs participant or Investigators request to discontinue treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None