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Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":61},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Dose-limiting toxicity (DLT)","Measurement of DLT of SPH5030 in all subjects","Up to 24 days",{"measure":14,"description":15,"timeFrame":12},"Maximum tolerated dose（MTD）","Measurement of MTD of SPH5030 in all subjects",{"measure":17,"description":18,"timeFrame":19},"Number of patients with adverse events","Adverse event type, incidence, duration, correlation with study drug","Up to 2 years",[21,24,26,28,30,32,34,36,38,40,42,44,46,49,52,55,58],{"measure":22,"description":23,"timeFrame":19},"Maximum serum concentration (Cmax) of SPH 5030","To characterize the PK (Pharmacokinetics) of SPH 5030",{"measure":25,"description":23,"timeFrame":19},"Time of maximum serum concentration (Tmax) SPH 5030",{"measure":27,"description":23,"timeFrame":19},"Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030",{"measure":29,"description":23,"timeFrame":19},"Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030",{"measure":31,"description":23,"timeFrame":19},"Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030",{"measure":33,"description":23,"timeFrame":19},"Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030",{"measure":35,"description":23,"timeFrame":19},"Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030",{"measure":37,"description":23,"timeFrame":19},"Terminal rate constant(λz) of SPH5030",{"measure":39,"description":23,"timeFrame":19},"Half-life (t1\u002F2) of SPH5030",{"measure":41,"description":23,"timeFrame":19},"Total clearance(CL) of SPH5030",{"measure":43,"description":23,"timeFrame":19},"Volume of distribution(Vz) of SPH5030",{"measure":45,"description":23,"timeFrame":19},"Percentage of area under 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Progression-free Survival (6mPFS)","Number of Patients Achieving 6-month Progression-free Survival",null,{"allocation":63,"interventionModel":64,"interventionModelDescription":61,"primaryPurpose":65,"observationalModel":61,"timePerspective":61,"maskingInfo":66},"NA","SINGLE_GROUP","TREATMENT",{"masking":67,"maskingDescription":61,"whoMasked":61},"NONE",[69],{"label":70,"type":71,"description":72,"interventionNames":73},"SPH5030 tablets","EXPERIMENTAL","Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day.\n\nEach subject will receive only one corresponding dose, and there were five dose groups: 50mg\u002F d, 100mg\u002F d, 200mg\u002F d, 300mg\u002F d and 400mg\u002F d.",[74],"Drug: SPH5030 tablets",[76],{"type":77,"name":70,"description":78,"armGroupLabels":79,"otherNames":61},"DRUG","SPH5030 tablets orally once or twice daily.",[70],[81],{"name":82,"affiliation":83,"role":84},"Binghe Xu","Cancer Institute and Hospital, Chinese Academy of Medical 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neijiang","Neijiang",{"type":100,"coordinates":287},[288,289],105.06216,29.58354,{"lat":289,"lon":288},[292],{"name":293,"role":88,"phone":61,"phoneExt":61,"email":61},"Xujuan Wang",{"facility":295,"status":94,"city":258,"state":61,"zip":61,"country":97,"countryCode":98,"cosmosGeoPoint":296,"geoPoint":298,"contacts":299},"Tianjin Cancer Hospital Airport Hospital",{"type":100,"coordinates":297},[263,264],{"lat":264,"lon":263},[300],{"name":301,"role":88,"phone":61,"phoneExt":61,"email":61},"Yehui Shi",{"type":303,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100458087",false,"NCT05245058","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","Inclusion Criteria:\n\n1. ECOG performance status of 0 to 1.\n2. Life expectancy of more than 3 months.\n3. At least one measurable lesion exists.(RECIST 1.1)\n4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.\n5. Required laboratory values including following parameters:\n\n   ANC: ≥ 1.5 x 109\u002FL Plt count: ≥ 90x 109\u002FL Hb: ≥ 90 g\u002FL TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL\u002Fmin\n6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.\n7. Blood pregnancy test was negative within 3 days prior to first dose.\n\nExclusion Criteria:\n\n1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.\n2. Known active infection within 2 weeks prior to baseline.\n3. Subjects with third space fluid that can not be controled.\n4. Subjects with uncontrolled or severe cardiovascular disease.\n5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.\n6. Subjects with severe lung disease.\n7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.\n8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.\n9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids.\n10. Uncured other tumors within 5 years.\n11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.\n12. Evidence of chronic active hepatitis B or C\n13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.\n14. Receive any live or attenuated live vaccine within 28 days prior to baseline.\n15. Evidence of severe allergies.\n16. Evidence of alcohol or drug abuse.\n17. Evidence of neurological or psychiatric disorders.","ALL","18 Years",{"count":313,"type":314},150,"ESTIMATED","INTERVENTIONAL",[317],"EARLY_PHASE1","To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors",[320],"HER2-positive Advanced Solid Tumors","2026-04-29",{"date":323,"type":324},"2026-05-05","ACTUAL",{"date":326,"type":324},"2022-01-21",{"date":328,"type":314},"2026-12-21",{"name":5,"class":6},17]