[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657075":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":57,"studyPopulation":50,"armGroups":58,"interventions":67,"overallOfficials":50,"centralContacts":73,"locations":79,"responsibleParty":97,"collaborators":50,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":50,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":50,"enrollmentInfo":108,"targetDuration":50,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":118,"whyStopped":50,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Hansoh BioMedical R&D Company","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":50},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maximum tolerated dose (MTD) or maximum applicable dose (MAD)","RDE will be determined using DLTs and number of participants with treatment-related adverse events as assessed by CTCAE v6.0 and preliminary clinical efficacy","From Day 1 to 21 days after first dose",{"measure":14,"description":15,"timeFrame":16},"Recommended dose for expansion (RDE) of HS-20197 monotherapy","To comprehensively evaluate the safety, pharmacokinetic profile, and preliminary clinical efficacy to determine the recommended dose for expansion (RDE).","From Day 1 to 90 days after last dose",[18,22,25,28,31,34,38,41,44,47],{"measure":19,"description":20,"timeFrame":21},"Objective response rate (ORR)","Defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1","From screening to up to 3 years after last dose",{"measure":23,"description":24,"timeFrame":21},"Disease control rate (DCR)","Defined as the proportion of participants with stable disease, or a complete or partial response, as determined by the investigator according to RECIST v1.1",{"measure":26,"description":27,"timeFrame":21},"Duration of response (DoR)","Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1",{"measure":29,"description":30,"timeFrame":21},"Progression-free survival (PFS)","Time from date of start of treatment to date of the first progression or death, whichever occurs first",{"measure":32,"description":33,"timeFrame":21},"Overall survival (OS)","Time from date of start of treatment to death from any cause",{"measure":35,"description":36,"timeFrame":37},"Maximum observed concentration (C[max])","Pharmacokinetic profile characterized by the maximum observed concentration (C\\[max\\]) of HS-20197","From the first dose until 90 days after the last dose",{"measure":39,"description":40,"timeFrame":37},"Time to maximum concentration (Tmax)","Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of HS-20197",{"measure":42,"description":43,"timeFrame":37},"Area under the curve (AUC)","Pharmacokinetic profile characterized by the area under the curve (AUC) of HS-20197",{"measure":45,"description":46,"timeFrame":37},"Terminal half-life (t1\u002F2)","Pharmacokinetic profile characterized by the terminal half-life (t1\u002F2) of HS-20197",{"measure":48,"description":49,"timeFrame":37},"Concentration of anti-drug antibodies (ADAs)","Immunogenicity profile characterized by concentration of ADAs",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":54,"observationalModel":50,"timePerspective":50,"maskingInfo":55},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":56,"maskingDescription":50,"whoMasked":50},"NONE","This is a multicenter, open-label, Phase I study evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of intravenously administered HS-20197 in participants with advanced solid tumors. The study comprises a Phase Ia dose-escalation phase followed by a Phase Ib dose-expansion phase.",[59,64],{"label":60,"type":61,"description":50,"interventionNames":62},"Phase Ia：Dose escalation","EXPERIMENTAL",[63],"Drug: HS-20197",{"label":65,"type":61,"description":50,"interventionNames":66},"Phase 1b Dose expansion",[63],[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":50},"DRUG","HS-20197","HS-20197 (Phase Ia：Dose escalation )\n\n* HS-20197 for IV infusion of various dose strengths administered in 21 day dosing cycles HS-20197 (Phase Ib:Dose expansion )\n* The recommended dose from the dose-escalation stage and other potential doses will be further explored",[65,60],[74],{"name":75,"role":76,"phone":77,"phoneExt":50,"email":78},"Ruihua Xu, PhD","CONTACT","+86-20-87343468","xurh2@sysucc.org.cn",[80],{"facility":81,"status":50,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":88,"coordinates":89},"Point",[90,91],113.25,23.11667,{"lat":91,"lon":90},[94],{"name":75,"role":76,"phone":95,"phoneExt":50,"email":96},"(86) 020-87343468","xurh@sysucc.org.cn",{"type":98,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100657075","phase-1-a-study-of-hs-20197-in-participants-with-advanced-solid-tumors-100657075",false,"NCT07834359","A Study of HS-20197 in Participants With Advanced Solid Tumors","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20197 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Males or females, aged ≥ 18 years.\n2. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.\n3. Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.\n\n   \\-\n\nExclusion Criteria:\n\n1. Participants have received or are receiving the following treatment:\n\n   * Anti-tumor drugs within 14 days prior to the first dose of study treatment; any other IMPs or macromolecular anti-tumor drugs within 28 days prior to the first dose of study treatment.\n   * Local radiotherapy within 2 weeks prior to the first dose of study treatment; irradiation of more than 30% of bone marrow or extensive radiotherapy within 4 weeks prior to the first dose of study treatment.\n   * Major surgery within 4 weeks prior to the first dose of study treatment.\n   * Participants previously treated with drugs that are moderate to strong inhibitors or moderate to strong inducers of cytochrome P450 (CYP) 3A4, strong inhibitors or strong inducers of CYP2D6, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP) or drugs with a narrow therapeutic range that are sensitive substrates of P-gp or BCRP within 7 days prior to the first dose of the IMP. Participants who need to receive these drugs during the study period should also be excluded.\n   * Current use of drugs known to prolong the QT interval or that may cause torsade de pointes. Participants who need to receive these drugs during the study period should also be excluded.\n   * Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.\n2. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior therapies (except alopecia and residual neurotoxicity).\n3. Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.\n4. Participants who are allergic to any component of HS-20197.","ALL","18 Years",{"count":109,"type":110},595,"ESTIMATED","INTERVENTIONAL",[113],"PHASE1","This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20197 in participants with advanced solid malignant tumors.",[116],"Solid Tumors",[116],"NOT_YET_RECRUITING","2026-09-16",{"date":121,"type":122},"2026-09-22","ACTUAL",{"date":124,"type":110},"2026-10-31",{"date":126,"type":110},"2029-12-31",{"name":5,"class":6},1]