A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gastric Type Adenocarcinoma (GAS) With STK11 Mutation

Intervention / Treatment
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* Drug: WX390
* Drug: Toripalimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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 At least one measurable lesion according to RECIST 1.1 Adequate organic function Signed and dated informed consent Exclusion Criteria: 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) Patients who are suffering active interstitial lung disease Evidence of ongoing or active serious infection History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection Inability to take medication orally Abuse of alcohol or drugs People with cognitive and psychological abnormality or with low compliance Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WX390 + Toripalimab<br>Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks). | Drug: WX390<br>* WX390 tablet, 0.9 mg once a day<br>* Other names: WXFL10030390;Drug: Toripalimab<br>* 240 mg, Day 1, every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | up to 24 weeks | 
| Overall survival (OS) | OS, defined as the time from the first treatment to death due to any cause. | up to 48 weeks | 
| Time to reach plasma Cmax (Tmax) of WX390 | Test the plasma drug concentration of WX390 to calculate Tmax. | up to 24 weeks |