Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-13
First Post:
2023-02-28
Brief Title:
A Study of KM602 in Patients With Advanced Solid Tumors
Sponsor:
Xuanzhu Biopharmaceutical Co Ltd
Organization:
Xuanzhu Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase 1 Safety and Tolerability Study of KM602 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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 study is a Phase 1 open-label first-in-human multicenter study to evaluate the safety tolerability pharmacokinetics and activity of KM602 as monotherapy in patients with advanced solid tumors
Detailed Description:
This Phase 1 study is comprised of dose escalation and expansions for KM602 monotherapy Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 33 dose escalation Patients will remain on study treatment until progression of disease unacceptable toxicity or other specified reason for discontinuation
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