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.
≥18 years of age
Histological or cytological confirmed advanced Gastric-type Endocervical Adenocarcinoma.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Life expectancy of more than 3 months
Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
Major surgery within 30 days prior to the initiation of study treatment
Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
Sequential
WX390
DrugWX390 tablet, 0.9 mg once a day
Toripalimab
Drug240 mg, Day 1, every 3 weeks
Progression-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.
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.
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).
Overall survival (OS)
OS, defined as the time from the first treatment to death due to any cause.
Time to reach plasma Cmax (Tmax) of WX390
Test the plasma drug concentration of WX390 to calculate Tmax.
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