Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345482
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-18
Brief Title:
A Study of MHB039A for Advanced Solid Tumor
Sponsor:
Minghui Pharmaceutical Hangzhou Ltd
Organization:
Minghui Pharmaceutical Hangzhou Ltd
Study Overview
Official Title:
A Phase III Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Phase III open label multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors
Detailed Description:
This first-in-human dose escalation and dose expansion study is to evaluate the safety tolerability pharmacokinetics PK immunogenicity pharmacodynamics PD and anti-tumor activity of MHB039A in patients with advanced solid tumor The Phase I stage dose escalationis to determine the maximum tolerated dose MTD The phase II stage dose expansionis to determine the recommended Phase 2 dose RP2D according to safety and efficacy in specific tumor types
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