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To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH5030 tablets | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH5030 tablets | Drug | SPH5030 tablets orally once or twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Measurement of DLT of SPH5030 in all subjects | Up to 24 days |
| Maximum tolerated dose(MTD) | Measurement of MTD of SPH5030 in all subjects | Up to 24 days |
| Number of patients with adverse events | Adverse event type, incidence, duration, correlation with study drug | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of SPH 5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 | Up to 2 years |
| Time of maximum serum concentration (Tmax) SPH 5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 |
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Inclusion Criteria:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Wang | Contact | +8615811589825 | wangxc@sphchina.com |
| Name | Affiliation | Role |
|---|---|---|
| Binghe Xu | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui provincial hospital | Recruiting | Hefei | Anhui | China |
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| 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 | 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 | 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 | Up to 2 years |
| Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 | 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 | Up to 2 years |
| Terminal rate constant(λz) of SPH5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 | Up to 2 years |
| Half-life (t1/2) of SPH5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 | Up to 2 years |
| Total clearance(CL) of SPH5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 | Up to 2 years |
| Volume of distribution(Vz) of SPH5030 | To characterize the PK (Pharmacokinetics) of SPH 5030 | 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 | Up to 2 years |
| Objective Response Rate (Investigator) | Determination of the Objective Response Rate of all patients by investigators | 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. | Up to 2 years |
| Disease control rate (DCR) | The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD. | 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. | Up to 2 years |
| 6-month Progression-free Survival (6mPFS) | Number of Patients Achieving 6-month Progression-free Survival | Up to 2 years |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | China |
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| Guangxi Cancer Hospital | Recruiting | Nanning | Guangxi | China |
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| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | China |
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| Anyang Cancer Hospital | Recruiting | Anyang | Henan | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
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| Linyi Cancer Hospital | Recruiting | Linyi | Shandong | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | China |
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| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300181 | China |
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| The First Affiliated Hospital of Bengbu Medical University | Recruiting | Bengbu | China |
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| The second people's hospital of neijiang | Recruiting | Neijiang | China |
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| Tianjin Cancer Hospital Airport Hospital | Recruiting | Tianjin | China |
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