Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373406
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-15
Brief Title:
A Study of MHB036C for Advanced Solid Tumor
Sponsor:
Minghui Pharmaceutical Hangzhou Ltd
Organization:
Minghui Pharmaceutical Hangzhou Ltd
Study Overview
Official Title:
A Phase III Dose Escalation and Dose Expansion Study of MHB036C for Advanced Solid Tumor to Evaluate the TolerabilitySafety Pharmacokinetics and Efficacy
Status:
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 dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C 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 MHB036C in patients with advanced solid tumor The Phase I stage is to determine the maximum tolerated dose MTD The phase II stage is 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