NCT06124963 A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
| NCT ID | NCT06124963 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd |
| Condition | Gastric Type Adenocarcinoma (GAS) With STK11 Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-08-25 |
| Primary Completion | 2025-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2023-08-25 with a primary completion date of 2025-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Yu Kang, PhD
PRINCIPAL INVESTIGATOR
The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Frequently Asked Questions
Who can join the NCT06124963 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gastric Type Adenocarcinoma (GAS) With STK11 Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06124963 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06124963 currently recruiting?
Yes, NCT06124963 is actively recruiting participants. Contact the research team at fcklcsyjg@163.com for enrollment information.
Where is the NCT06124963 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06124963 clinical trial?
NCT06124963 is sponsored by Shanghai Jiatan Pharmatech Co., Ltd. The principal investigator is Yu Kang, PhD at The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital). The trial plans to enroll 20 participants.