Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 7:15 AM
Study NCT ID:
NCT05851092
Status:
RECRUITING
Last Update Posted:
2023-07-07
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Clinical Study of HRS-2189 in the Treatment of Patients With Advanced Malignant Tumors
Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
A Single Arm, Open, Multicenter Phase I Clinical Study on the Safety, Tolerance, and Pharmacokinetics of HRS-2189 Single Drug in Patients With Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-04
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:
This study is a multi center, open label, dose increasing/dose expanding/efficacy expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in patients with advanced malignant solid tumors. This study was divided into three stages: dose escalation, dose expansion, and efficacy expansion.
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?: