Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375044
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-04-16
Brief Title:
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor:
Jiangsu Simcere Pharmaceutical Co Ltd
Organization:
Jiangsu Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I First-in-human Open-label Trial to Investigate the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of SIM0500 A Humanized GPRC5D-BCMA-CD3 Tri-specific Antibody in Participants With Relapsed or Refractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-05
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 is an open-label multicenter phase 1 clinical trial to evaluate the safety and tolerability efficacy and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple MyelomaRRMM The trial is consisted of two parts Part 1 dose escalation and Part 2 dose optimization In both parts SIM0500 will be administered until disease progression intolerable toxicity withdraw of consent or end of trial
Detailed Description:
None
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