Actively Recruiting
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2026-05-05
150
Participants Needed
17
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
CONDITIONS
Official Title
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status of 0 to 1
- Life expectancy greater than 3 months
- At least one measurable lesion as defined by RECIST 1.1
- Histologically or cytologically confirmed HER2-positive metastatic solid tumor that failed prior standard treatment or has no standard treatment
- Adequate laboratory values: ANC 8 1.5 x 10^9/L, platelet count 8 90 x 10^9/L, hemoglobin 8 90 g/L, total bilirubin 4 1.5 x ULN, ALT and AST 4 2.5 x ULN, creatinine clearance rate 4 ULN or 8 50 mL/min
- Toxicity from previous antitumor therapy returned to baseline or CTCAE 4 class 1
- Negative blood pregnancy test within 3 days prior to first dose
You will not qualify if you...
- Received prescribed treatment at the prescribed time prior to first dosing
- Known active infection within 2 weeks prior to baseline
- Presence of uncontrolled third space fluid
- Uncontrolled or severe cardiovascular disease
- Uncontrolled hypokalemia or hypomagnesemia before study entry
- Severe lung disease
- Unable to swallow tablets or have gastrointestinal absorption dysfunction
- Use of potent CYP3A4 or CYP2C8 inhibitors or inducers
- Steroid treatment for more than 50 days before or need for long-term steroid use
- Uncured other tumors within 5 years
- 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 not controlled after treatment
- Received 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Anhui provincial hospital
Hefei, Anhui, China
Actively Recruiting
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
4
Guangxi Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
5
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
6
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
7
Anyang Cancer Hospital
Anyang, Henan, China
Actively Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
9
Xiangyang Central Hospital
Xiangyang, Hubei, China
Actively Recruiting
10
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Actively Recruiting
11
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
12
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
13
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
14
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300181
Actively Recruiting
15
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
Actively Recruiting
16
The second people's hospital of neijiang
Neijiang, China
Actively Recruiting
17
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
Actively Recruiting
Research Team
X
Xingchen Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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