SPH5030 tablets: SPH5030 tablets orally once or twice daily.
Study summary
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
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.
Primary outcome measure(s)
Dose-limiting toxicity (DLT) — Up to 24 days Measurement of DLT of SPH5030 in all subjects
Maximum tolerated dose(MTD) — Up to 24 days Measurement of MTD of SPH5030 in all subjects
Number of patients with adverse events — Up to 2 years Adverse event type, incidence, duration, correlation with study drug
Trial sites (17)
Facility
City
Region
Status
Anhui provincial hospital
Hefei
Anhui
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Guangxi Cancer Hospital
Nanning
Guangxi
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Anyang Cancer Hospital
Anyang
Henan
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Xiangyang Central Hospital
Xiangyang
Hubei
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Linyi Cancer Hospital
Linyi
Shandong
Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
China
Recruiting
The second people's hospital of neijiang
Neijiang
China
Recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin
China
Recruiting
More Shanghai Pharmaceuticals Holding Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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