NCT06117540 A Study of WX390 in Patients With Advanced Solid Tumors
| NCT ID | NCT06117540 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-05-11 |
| Primary Completion | 2025-06-12 |
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 70 participants in total. It began in 2021-05-11 with a primary completion date of 2025-06-12.
⚠ 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 efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are: * PFS, OS, DoR at week 48; * antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.
Eligibility Criteria
Inclusion Criteria: * ≥18 years of age * Histological or cytological confirmed advanced solid tumor, standard regimen failed * 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 organ 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 * 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 * Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment * Active hepatitis B or C infection * Inability to take medication orally * Abuse of alcohol or drugs * Pregnant or lactating women * People with cognitive and psychological abnormality or with low compliance
Contact & Investigator
Xiaohua Wu, PhD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06117540 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Solid Tumor. 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 NCT06117540 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 NCT06117540 currently recruiting?
Yes, NCT06117540 is actively recruiting participants. Contact the research team at doc_lijiajia@163.com for enrollment information.
Where is the NCT06117540 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06117540 clinical trial?
NCT06117540 is sponsored by Shanghai Jiatan Pharmatech Co., Ltd. The principal investigator is Xiaohua Wu, PhD at Fudan University. The trial plans to enroll 70 participants.