Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639256
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Phase 12 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multiple-center Phase 12 Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label phase 12 study to evaluate the safety efficacy and pharmacokinetic PKpharmacodynamic PD characteristics of HY07121 in participants with advanced solid tumors
Detailed Description:
The study starts with a dose escalation part Part 1 followed by a dose expansion part Part 2 The main purpose of this study is to evaluate the safety and tolerability of the drug HY07121 and determine the maximum tolerated dose MTD if any andor the recommended doses RD and preliminary anti-tumor activity Additional purposes of the study are to evaluate the pharmacokinetics PK properties immunogenicity correlation of the biomarkers and PK profile with anti-tumor activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None