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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX390 + Toripalimab | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX390 | Drug | WX390 tablet, 0.9 mg once a day |
|
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaoli He | Contact | 008621-63453967 | fcklcsyjg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Kang, PhD | The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital) | Recruiting | Shanghai | Shanghai Municipality | 200090 | China |
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WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)
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| Toripalimab | Drug | 240 mg, Day 1, every 3 weeks |
|
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 |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
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