Evaluating WX390 for patients with advanced solid tumors
An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors
PHASE2 · Shanghai Jiatan Pharmatech Co., Ltd · NCT06117540
This study is testing a new oral medication called WX390 to see if it helps people with advanced solid tumors live longer and feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd (industry) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06117540 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of WX390 in patients diagnosed with advanced solid tumors. It is an open-label, multicenter phase II trial where participants will undergo a 4-week screening period followed by 12 cycles of treatment with WX390, taken orally. Efficacy and safety evaluations will be conducted at specified intervals, focusing on progression-free survival, overall survival, and duration of response at weeks 24 and 48.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced solid tumors who have failed standard treatment regimens.
Not a fit: Patients who have undergone recent anti-cancer therapy or major surgery, or those with active infections or certain health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have not responded to standard therapies.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating new treatments for advanced solid tumors.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Principal investigator: Xiaohua Wu, PhD — Fudan University
- Study coordinator: Jiajia Li
- Email: doc_lijiajia@163.com
- Phone: 008621-64175590
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.
Conditions: Solid Tumor