Combining WX390 and Toripalimab for Advanced Gastric-type Endocervical Adenocarcinoma with STK11 Mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and preliminary efficacy of WX390 in combination with Toripalimab for patients with advanced Gastric-type Endocervical Adenocarcinoma harboring STK11 mutations. It is an open-label, multicenter phase II trial where participants will undergo a 28-day screening period followed by 8 cycles of treatment. The study will assess pharmacokinetics, safety, and efficacy through regular evaluations during treatment cycles. Participants will be monitored for safety for 8 weeks after the last dose.

Why it matters

Who can join: the full rules

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

Where it's running

• The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yu Kang, PhD — The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
• Study coordinator: Gaoli He
• Email: fcklcsyjg@163.com
• Phone: 008621-63453967

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.