SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

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.
• 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.