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

Shanghai Jiatan Pharmatech

Status and phase

Enrolling

Phase 2

Conditions

Gastric Type Adenocarcinoma (GAS) With STK11 Mutation

Treatments

Drug: Toripalimab

Drug: WX390

Study type

Interventional

Funder types

Industry

Identifiers

NCT06124963

JYP0390M207

Details and patient eligibility

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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