To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
SPH5030 tablets orally once or twice daily.
Anhui provincial hospital
Hefei, Anhui, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Dose-limiting toxicity (DLT)
Measurement of DLT of SPH5030 in all subjects
Time frame: Up to 24 days
Maximum tolerated dose(MTD)
Measurement of MTD of SPH5030 in all subjects
Time frame: Up to 24 days
Number of patients with adverse events
Adverse event type, incidence, duration, correlation with study drug
Time frame: Up to 2 years
Maximum serum concentration (Cmax) of SPH 5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Time of maximum serum concentration (Tmax) SPH 5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGGuangxi Cancer Hospital
Nanning, Guangxi, China
RECRUITINGThe Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGAnyang Cancer Hospital
Anyang, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
RECRUITING...and 7 more locations
Time frame: Up to 2 years
Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Terminal rate constant(λz) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Half-life (t1/2) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Total clearance(CL) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Volume of distribution(Vz) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030
To characterize the PK (Pharmacokinetics) of SPH 5030
Time frame: Up to 2 years
Objective Response Rate (Investigator)
Determination of the Objective Response Rate of all patients by investigators
Time frame: Up to 2 years
Duration of remission (DOR)
Time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review as per RECIST v1.1.
Time frame: Up to 2 years
Disease control rate (DCR)
The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD.
Time frame: Up to 2 years
Progression-free survival (PFS)
The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.
Time frame: Up to 2 years
6-month Progression-free Survival (6mPFS)
Number of Patients Achieving 6-month Progression-free Survival
Time frame: Up to 2 years