Actively Recruiting
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
Led by Shanghai Jiatan Pharmatech Co., Ltd · Updated on 2024-12-10
20
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically or cytologically confirmed advanced Gastric-type Endocervical Adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy greater than 3 months
- At least one measurable lesion according to RECIST 1.1
- Adequate organ function
- Signed and dated informed consent
You will not qualify if you...
- Received anti-cancer therapy within 30 days before starting study treatment
- Had major surgery within 30 days before starting study treatment
- Used corticosteroids or other immunosuppressants within 2 weeks before the first study dose
- Have unresolved toxicity from previous anti-tumor treatment above Grade 1 (except alopecia)
- Have active interstitial lung disease
- Have active or ongoing serious infection
- Have history of HIV infection or active hepatitis B or C infection
- Unable to take medication by mouth
- Abuse alcohol or drugs
- Have cognitive or psychological disorders or low treatment compliance
- Are pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Shanghai, Shanghai Municipality, China, 200090
Actively Recruiting
Research Team
G
Gaoli He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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