Status:
RECRUITING
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
Lead Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Conditions:
Gastric Type Adenocarcinoma (GAS) With STK11 Mutation
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 muta...
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 scr...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 9 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06124963
Start Date
August 25 2023
End Date
December 9 2026
Last Update
December 10 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Shanghai, Shanghai Municipality, China, 200090