A Study of NWY001 in Subjects With Advanced Solid Tumors
This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced solid tumors including 2 parts: Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part
| Condition(s) | Advanced Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced solid tumors including 2 parts: Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part |
| Who can participate | Inclusion Criteria: 1. Willingness to sign a written informed consent document 2. Participant with advanced solid malignant tumor that has relapsed from or is refractory to standard therapy or for which no standard therapy exists 3. 18\~75 years of age at the time of screening 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 5. Life expectancy ≥3 months 6. Laboratory tests meet the following criteria (no corrective treatment, such as G-CSF, erythropoietin, and blood transfusion, within 14 days before first dose): 1\) absolute neutrophil count (ANC) ≥1.5×109/L 2) platelet ≥100×109/L 3) hemoglobin ≥90 g/L 4) creatinine clearance \>50 mL/min (according to Cockcroft-Gault equation) 5) both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper l |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chipscreen Biosciences, Ltd. |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2024-01-05 |
| NCT ID | NCT05979155 |
| Official listing | https://clinicaltrials.gov/study/NCT05979155 |