Overview
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
Eligibility
Inclusion Criteria:
- ECOG performance status of 0 to 1.
- Life expectancy of more than 3 months.
- At least one measurable lesion exists.(RECIST 1.1)
- Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.
- 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
- Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.
- Blood pregnancy test was negative within 3 days prior to first dose.
Exclusion Criteria:
- Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.
- Known active infection within 2 weeks prior to baseline.
- Subjects with third space fluid that can not be controled by drainage or other methods.
- Subjects with uncontrolled or severe cardiovascular disease.
- Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- Subjects with severe lung disease.
- Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.
- Steroid treatment for more than 50 days before, or in need of long-term use of steroids.
- Uncured other tumors within 5 years.
- Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.
- Evidence of chronic active hepatitis B or C
- Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.
- Receive any live or attenuated live vaccine within 28 days prior to baseline.
- Evidence of severe allergies.
- Evidence of alcohol or drug abuse.
- Evidence of neurological or psychiatric disorders.