Combining WX390 and Toripalimab for 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
This study is testing if a new combination of medications, WX390 and Toripalimab, can help people with advanced Gastric-type Endocervical Adenocarcinoma that has STK11 mutations.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd Industry-sponsored |
| Drugs / interventions | Toripalimab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06124963 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced Gastric-type Endocervical Adenocarcinoma and STK11 mutations.
Not a fit: Patients who have received recent anti-cancer therapies or have certain health conditions, such as active infections or interstitial lung disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a specific type of advanced cancer that currently has limited treatment options.
How similar studies have performed: While this specific combination is novel, similar approaches in targeting specific mutations in cancer have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.