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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiatan Pharmatech Co., Ltd

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