[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634407":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":15,"armGroups":55,"interventions":62,"overallOfficials":15,"centralContacts":67,"locations":73,"responsibleParty":90,"collaborators":15,"id":92,"slug":15,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":15,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":15,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":76,"whyStopped":15,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":15},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Maximal tolerance dose (MTD) of HDM2024","The MTD is defined as the dose level at which the estimated toxicity probability is closest to the target toxicity rate during the Dose-limiting toxicity (DLT) observation period of the dose escalation stage.","DLT will be evaluated on 21 days of observation period",{"measure":14,"description":15,"timeFrame":16},"Determination of the Recommended Phase 2 dose (RP2D)",null,"Approximately 1 years",{"measure":18,"description":19,"timeFrame":16},"Incidence and severity of Treatment-Emergent Adverse Events","Incidence rates of adverse events (AE), serious adverse events (SAE)per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0.",[21,24,28,32,36,39,42,45],{"measure":22,"description":23,"timeFrame":16},"Time to peak (Tmax) of HDM2024","Tmax of HDM2024, total antibody, and exatecan will be measured",{"measure":25,"description":26,"timeFrame":27},"Half-life time (t1\u002F2) of HDM2024","t1\u002F2 of HDM2024, total antibody, and exatecan will be measured","Approximately 1year",{"measure":29,"description":30,"timeFrame":31},"Peak Plasma Concentration (Cmax) of HDM2024","Cmax of HDM2024, total antibody, and exatecan will be measured","Approximately 1 year",{"measure":33,"description":34,"timeFrame":35},"Area under the plasma concentration versus time curve (AUC) of HDM2024","AUC of HDM2024, total antibody, and exatecan will be measured","approximately 1 year",{"measure":37,"description":38,"timeFrame":31},"Objective response rate (ORR)","ORR assessed based on RECIST v1.1 criterion",{"measure":40,"description":41,"timeFrame":31},"Disease control rate (DCR)","DCR assessed based on RECIST v1.1 criterion",{"measure":43,"description":44,"timeFrame":27},"Progression-free survival (PFS)","PFS assessed based on RECIST v1.1 criterion",{"measure":46,"description":47,"timeFrame":31},"Overall survival (OS)","OS of 6-months and 12-months",{"allocation":49,"interventionModel":50,"interventionModelDescription":15,"primaryPurpose":51,"observationalModel":15,"timePerspective":15,"maskingInfo":52},"NA","SINGLE_GROUP","TREATMENT",{"masking":53,"maskingDescription":15,"whoMasked":15},"NONE","Target population are patients with advanced solid tumors .",[56],{"label":57,"type":58,"description":59,"interventionNames":60},"HDM2024","EXPERIMENTAL","HDM2024 ( the antibody-drug conjugate (ADC) drug targeting epidermal growth factor receptor (EGFR) \\& human epidermal growth factor receptor 3 (HER3) )",[61],"Drug: HDM2024",[63],{"type":64,"name":57,"description":65,"armGroupLabels":66,"otherNames":15},"DRUG","ADC drug targeting EGFR and HER3",[57],[68],{"name":69,"role":70,"phone":71,"phoneExt":15,"email":72},"Zhou Caicun","CONTACT","+8613301825532","caicunzhoudr@163.com",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200123","China","CN",{"type":83,"coordinates":84},"Point",[85,86],121.45806,31.22222,{"lat":86,"lon":85},[89],{"name":69,"role":70,"phone":71,"phoneExt":15,"email":72},{"type":91,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100634407",false,"NCT07539285","A Study of HDM2024 in Participants With Advanced Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Efficacy of HDM2024 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Participants who voluntarily participate in this study and sign the written Informed Consent Form (ICF) after being fully informed.\n* 2\\. Male or female participants aged 18 to 75 years (inclusive).\n* 3\\. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors who have experienced disease progression on or after standard therapy , or are intolerant to standard therapy, or for whom no effective standard of care is available.\n* 4\\. Participants who are able to provide fresh or archival tumor tissue during the screening period. Tumor tissue will be collected for biomarker testing at a central laboratory, including immunohistochemistry for EGFR and HER3 .\n* 5\\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 .\n* 6\\. Life expectancy ≥3 months.\n* 7\\. According to RECIST v1.1, the participant must have at least one measurable lesion .\n* 8\\. Participants with good organ function as demonstrated by screening laboratory test results.\n* 9\\. The fertile participants agreed to take effective contraceptive measures during the study and after its conclusion; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before dosing.\n* 10\\. Participants should be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* 1\\. Participants who have previously received ADC containing exatecan , or an ADC primarily directed against EGFR and\u002For HER3.\n* 2\\. Participants who have received the following treatments:\n\n  1. Participants who have undergone major surgery within 4 weeks before the first dose;\n  2. Participants who have received radiotherapy involving the bone marrow or extensive radiotherapy within 4 weeks before the first dose; or local radiotherapy within 2 weeks before the first dose;\n  3. Participants who are receiving continuous systemic corticosteroid therapy ; low-dose corticosteroids are permitted if the dose of systemic corticosteroids has been stable for 4 weeks;\n  4. Participants who have received anti-tumor treatments within 4 weeks before the first dose, or are still within 5 half-lives of the last dose of the most recent anticancer therapy (whichever is longer). Traditional Chinese medicines with approved anticancer indications within 2 weeks prior to the first administration of study drug.\n* 3\\. Participants with other malignant tumor within the past 5 years, other than the tumor treated in this study, with the exception of locally cured tumors .\n* 4\\. Participants with related AEs (except for alopecia and ≤ Grade 2 sensory neuropathy) caused by previous treatment that have not recovered to ≤ Grade 1 or baseline level.\n* 5\\. Participants with known weight loss of \\>10% within 2 months before the first dose of the study drug or other indicators showing severe malnutrition.\n* 6\\. Participants with serious complications or medical histories involving important organs.\n* 7\\. Participants with known active central nervous system (CNS) metastasis.\n* 8\\. Participants with any of the cardiovascular\u002Fcerebrovascular disorders, symptoms, or manifestations.\n* 9\\. Participants with the following conditions will be excluded at screening: active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), with the exception of asymptomatic chronic hepatitis B or C virus carriers.\n* 10\\. Participants with a history of interstitial pneumonia or other moderate to severe lung disorders that seriously affect lung function.\n* 11\\. Participants with severe infection during the screening period.\n* 12\\. Participants with other diseases that may affect the efficacy and safety of the study drug.\n* 13\\. Participants with uncontrolled pericardial effusion, uncontrolled pleural effusion, or clinically significant moderate or greater ascites during the screening period.\n* 14\\. Participants with unstable thrombotic events requiring therapeutic intervention within 6 months before screening; however, thrombosis related to infusion devices is not included.\n* 15\\. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study period.\n* 16\\. Participants who have received strong CYP3A4 inhibitors and inducers therapy within 1 week before dosing, or are expected to require long-term use of strong CYP3A4 inhibitors and inducers during the study intervention and within 30 days after the last dose .\n* 17\\. Participants with history of solid organ transplant.\n* 18\\. Participants with known or suspected history of severe allergy to any component of the study drug or its analogues.\n* 19\\. Pregnant and lactating women.\n* 20\\. Participants who are deemed unsuitable for this study (e.g., poor compliance, etc.) by the investigator.","ALL","18 Years","75 Years",{"count":102,"type":103},63,"ESTIMATED","INTERVENTIONAL",[106],"PHASE1","The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:\n\n* Is the drug safe and tolerable ?\n* Does the drug exhibit antitumor activity ?\n\nParticipants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.",[109],"Advanced Solid Tumors",[111,112,113,114],"ADC","advanced solid tumors","EGFR","HER3","2026-04-13",{"date":117,"type":118},"2026-04-20","ACTUAL",{"date":120,"type":103},"2026-04-10",{"date":122,"type":103},"2028-12-28",{"name":5,"class":6},1]