Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124963
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-30
Brief Title:
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
Sponsor:
Shanghai Jiatan Pharmatech Co Ltd
Organization:
Shanghai Jiatan Pharmatech Co Ltd
Study Overview
Official Title:
A Phase II Study to Evaluate the Safety Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
Status:
RECRUITING
Status Verified Date:
2023-11
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 Gastric-type Endocervical Adenocarcinoma with STK11 mutations The main questions it aims to answer are
Pharmacokinetic PK characteristics of WX390 combined with Toripalimab treatment
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
Pharmacokinetic PK characteristics of WX390 combined with Toripalimab treatment
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 II clinical trial After being informed about the study and potential risks all patients giving written informed consent will undergo a 28-days 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?:
None