RecruitingEarly Phase 1NCT05245058
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Enrollment
150 participants
Start Date
Jan 21, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria17
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGSPH5030 tablets
SPH5030 tablets orally once or twice daily.
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05245058