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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
WX390 tablet, 0.9 mg once a day
240 mg, Day 1, every 3 weeks
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival rate (PFS rate)
PFS rate, defined as the proportion of patients who have not experienced disease progression (PD) or death due to any cause during the study period.
Time frame: up to 24 weeks
Objective response rate (ORR)
ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) confirmed by RECIST v1.1 assessment.
Time frame: up to 24 weeks
Progression-free survival (PFS)
PFS, defined as the time from the first treatment to the first occurrence of disease progression or death due to any cause during the study period (whichever comes first).
Time frame: up to 24 weeks
Overall survival (OS)
OS, defined as the time from the first treatment to death due to any cause.
Time frame: up to 48 weeks
Time to reach plasma Cmax (Tmax) of WX390
Test the plasma drug concentration of WX390 to calculate Tmax.
Time frame: up to 24 weeks
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