Ignite Creation Date:
2024-07-17 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484985
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Study of AXT-1003 in Subjects With Advanced Malignant Tumors
Sponsor:
Axter Therapeutics Beijing Co Ltd
Organization:
Axter Therapeutics Beijing Co Ltd
Study Overview
Official Title:
An Open-label Multicenter Phase I Safety Study of AXT-1003 in Subjects With Advanced Malignant Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
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 a Phase I study of AXT-1003 to assess the safety tolerability and pharmacokinetics in patients with advanced malignancies
Detailed Description:
AXT1003-1102 is a multicenter open-label Phase I safety study of AXT-1003 in patients with advanced malignancies It is designed to observe the safety of AXT-1003 in patients with advanced malignancies determine the maximum tolerated dose MTD and recommended Phase 2 dose RP2D evaluate the pharmacokinetic profile and explore the preliminary antitumor activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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