Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566079
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Study of ISM6331 in Participants With AdvancedMetastatic Malignant Mesothelioma or Other Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter FIH Study to Evaluate the Safety Tolerability PharmacokineticsPharmacodynamics and Preliminary Efficacy of ISM6331 in Participants With AdvancedMetastatic Malignant Mesothelioma or Other Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 Phase 1 open-label multicenter FIH study to evaluate the safety tolerability recommended Phase 2 dose RP2D PKPD and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors The study consists of two parts a dose escalation part Part 1 and a dose selection optimization part Part 2
Detailed Description:
None
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