A Study of XZB-0004 in Patients With Solid Tumors
XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL. This is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identi
| Condition(s) | Advanced Solid Tumor, NSCLC |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL. This is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Penpulimab in patients with NSCLC or advanced solid tumors. |
| Who can participate | Inclusion Criteria: 1. Patient has signed informed consent before any trial related activities. 2. Be 18 years of age or older and less than 75 years at the time of signing the informed consent. 3. Part 1: Have a histologically or cytologically confirmed diagnosis of a solid tumour malignancy; Part 2：Have a histologically or cytologically confirmed diagnosis of a NSCLC or solid tumour malignancy. 4. Have evaluable (for Part 1) or measurable (for Part 2) disease as the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. 5. Have a performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 6. Have adequate organ function. 7. Have recovered to ≤ grade 1 or Meet the requirements of the study from the effects of any prior cancer therapy, except f |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Xuanzhu Biopharmaceutical Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-03-24 |
| NCT ID | NCT05772455 |
| Official listing | https://clinicaltrials.gov/study/NCT05772455 |