Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05772455
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-02-20
Brief Title:
A Study of XZB-0004 in Patients With Solid Tumors
Sponsor:
Xuanzhu Biopharmaceutical Co Ltd
Organization:
Xuanzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Open-label Dose-escalation Study of the Safety Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
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:
XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL
This is an open-label multicentre phase I study of XZB-0004 in patients with solid tumors Part 1 is a dose-escalation study to evaluate the safety pharmacokinetic PK and pharmacodynamic profile of XZB-0004 and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Peamplimab in patients with NSCLC or advanced solid tumors
This is an open-label multicentre phase I study of XZB-0004 in patients with solid tumors Part 1 is a dose-escalation study to evaluate the safety pharmacokinetic PK and pharmacodynamic profile of XZB-0004 and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Peamplimab in patients with NSCLC or advanced solid tumors
Detailed Description:
None
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