SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
NCT ID: NCT05245058
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
150 participants
INTERVENTIONAL
2022-01-21
2025-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SPH5030 tablets
Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day.
Each subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.
SPH5030 tablets
SPH5030 tablets orally once or twice daily.
Interventions
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SPH5030 tablets
SPH5030 tablets orally once or twice daily.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Binghe Xu
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Anhui provincial hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi Cancer Hospital
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Anyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, , China
The second people's hospital of neijiang
Neijiang, , China
Tianjin Cancer Hospital Airport Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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Yueyin Pan
Role: primary
Binghe Xu
Role: primary
Weimin Xie
Role: primary
Cuizhi Geng
Role: primary
Qingyuan Zhang
Role: primary
Jing Sun
Role: primary
Min Yan
Role: primary
Yuehua Wang
Role: primary
Jinhai tang
Role: primary
Fujian Liu
Role: primary
Jingfen Wang
Role: primary
Shuqun Zhang
Role: primary
Tingjing Yao
Role: primary
Huan Zhou
Role: backup
Xujuan Wang
Role: primary
Yehui Shi
Role: primary
Other Identifiers
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SPH5030-101
Identifier Type: -
Identifier Source: org_study_id
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