ClinicalTrialsFinder
RecruitingPhase 2NCT06124963

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

A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations

Sponsor

Shanghai Jiatan Pharmatech Co., Ltd

Enrollment

20 participants

Start Date

Aug 25, 2023

Study Type

INTERVENTIONAL

Conditions

Gastric Type Adenocarcinoma (GAS) With STK11 Mutation

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • ≥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 Criteria11

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGWX390

WX390 tablet, 0.9 mg once a day

DRUGToripalimab

240 mg, Day 1, every 3 weeks

Locations(1)

The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06124963