Combining WX390 and Toripalimab for advanced solid tumors
A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
This study is testing if a new combination of two drugs, WX390 and Toripalimab, can safely help people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Jiatan Pharmatech Co., Ltd Industry-sponsored |
| Drugs / interventions | Toripalimab |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT06117566 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and preliminary efficacy of WX390 in combination with Toripalimab for patients with advanced solid tumors. It is an open-label, multicenter phase Ib/IIa trial where participants will undergo a 4-week screening period followed by 8 cycles of treatment. The study will assess the maximum tolerated dose and any dose-limiting toxicities, along with safety and efficacy evaluations conducted every treatment cycle. Participants will be monitored for 8 weeks after the last dose to gather comprehensive safety data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced solid tumors who have failed standard treatments or have no available standard options.
Not a fit: Patients who have received anti-cancer therapy within 30 days or have active interstitial lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is exploring a novel combination, similar studies have shown promise in targeting advanced solid tumors with immunotherapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years of age * Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available * 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 * 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
Changchun, Jilin
- the first affiliated hospital of Jilin university — Changchun, Jilin, China (Recruiting)
Study contacts
- Principal investigator: Yanhua Ding, PhD — the first affiliated hospital of Jilin university
- Study coordinator: Xiaoxue Zhu
- Email: 123999320@qq.com
- Phone: 0086431-88782222
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.