SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
| Condition(s) | HER2-positive Advanced Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors |
| Who can participate | Inclusion Criteria: 1. ECOG performance status of 0 to 1. 2. Life expectancy of more than 3 months. 3. At least one measurable lesion exists.(RECIST 1.1) 4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment. 5. Required laboratory values including following parameters: ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min 6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1. 7. Blood pregnancy test was negative within 3 days prior to first dose. Exclusion Criteria: 1. Subjects who have received the prescribed treatment at the prescribed ti |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shanghai Pharmaceuticals Holding Co., Ltd |
| Locations | Hefei, Anhui, China; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China; Harbin, Heilongjiang, China (+11 more sites) |
| Start date | 2022-01-21 |
| NCT ID | NCT05245058 |
| Official listing | https://clinicaltrials.gov/study/NCT05245058 |