Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-07
Brief Title:
Study of ISM3412 in Participants With Locally AdvancedMetastatic Solid Tumors
Sponsor:
InSilico Medicine Hong Kong Limited
Organization:
InSilico Medicine Hong Kong Limited
Study Overview
Official Title:
A Phase 1 Open-Label Multicenter First-in-Human Study to Evaluate the Safety Tolerability PharmacokineticsPharmacodynamics and Preliminary Efficacy of ISM3412 in Participants With Locally AdvancedMetastatic Solid Tumors
Status:
NOT_YET_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:
The study has consists of two parts a dose escalation part Part 1 and a dose selection optimization part Part 2 The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advancedmetastatic solid tumors and to determine the RP2D of ISM3412
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