Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 6:43 AM
Study NCT ID:
NCT05749432
Status:
RECRUITING
Last Update Posted:
2025-04-18
First Post:
2023-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of Hemay181 in Patients With Advanced Solid Tumors
Sponsor:
Ganzhou Hemay Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Antitumor Efficacy of Hemay181 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-03
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:
The study will be conducted in about 51 participants in total. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor efficacy of Hemay181 in patients with advanced solid tumors.
Detailed Description:
The primary purpose of this study is to evaluate the safety and tolerability of Hemay181 in patients with advanced solid tumors, and to explore the maximum tolerated dose. The secondary purpose is to evaluate the pharmacokinetic profile of Hemay181 in patients with advanced solid tumors and to evaluate the preliminary evaluation of the anti-tumor efficacy of Hemay181.
The study will be conducted in two parts. Part one, trial will be conducted in about 24 subjects to determine safety and tolerability of Hemay181 in patients with advanced solid tumors. Part two, approximately 15-27 additional subjects with advanced solid tumors are included to better define the tolerability and preliminary efficacy of Hemay181.
The study will be conducted in two parts. Part one, trial will be conducted in about 24 subjects to determine safety and tolerability of Hemay181 in patients with advanced solid tumors. Part two, approximately 15-27 additional subjects with advanced solid tumors are included to better define the tolerability and preliminary efficacy of Hemay181.
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?: