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Clinical Trials in China / NCT05245058
Recruiting Phase EARLY_PHASE1

SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors

NCT05245058 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Phase
Phase EARLY_PHASE1
Started
2022-01-21
Last updated
2026-05-05

Condition(s) studied

HER2-positive Advanced Solid Tumors

Investigational drug(s) / intervention(s)

SPH5030 tablets

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)

Trial sites (17)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT05245058 on ClinicalTrials.gov ↗ ← All trials in China