Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-28 @ 8:54 AM
Study NCT ID:
NCT06117566
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2023-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Organization:
Study Overview
Official Title:
A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-11
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 goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced solid tumors. The main questions it aims to answer are:
* the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390;
* safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.
* the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390;
* safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.
Detailed Description:
This study will be an open-label, multicenter phase Ib/IIa clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
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?: