Status:
RECRUITING
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
HER2-positive Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05245058
Start Date
January 21 2022
End Date
December 21 2025
Last Update
August 17 2025
Active Locations (17)
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1
Anhui provincial hospital
Hefei, Anhui, China
2
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
4
Guangxi Cancer Hospital
Nanning, Guangxi, China