A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

SPH5030-101

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors

2022-01-21

2024-06-21

2024-06-21

Recruiting

Early phase I

114

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 time prior to first dosing. 2. Known active infection within 2 weeks prior to baseline. 3. Subjects with third space fluid that can not be controled by drainage or other methods. 4. Subjects with uncontrolled or severe cardiovascular disease. 5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. 6. Subjects with severe lung disease. 7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption. 8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer. 9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids. 10. Uncured other tumors within 5 years. 11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis. 12. Evidence of chronic active hepatitis B or C 13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment. 14. Receive any live or attenuated live vaccine within 28 days prior to baseline. 15. Evidence of severe allergies. 16. Evidence of alcohol or drug abuse. 17. Evidence of neurological or psychiatric disorders.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}

2024-03-28