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Trial Title:
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
NCT ID:
NCT06124963
Condition:
Gastric Type Adenocarcinoma (GAS) With STK11 Mutation
Conditions: Official terms:
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg,
intravenous, Day 1, every 3 weeks)
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
WX390
Description:
WX390 tablet, 0.9 mg once a day
Arm group label:
WX390 + Toripalimab
Other name:
WXFL10030390
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
240 mg, Day 1, every 3 weeks
Arm group label:
WX390 + Toripalimab
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 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:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Address:
City:
Shanghai
Zip:
200090
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Kang, PhD
Investigator:
Last name:
Yu Kang, PhD
Email:
Principal Investigator
Start date:
August 25, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Shanghai Jiatan Pharmatech Co., Ltd
Agency class:
Industry
Source:
Shanghai Jiatan Pharmatech Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06124963
