[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634407":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":19,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":19,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HDM2024","EXPERIMENTAL","HDM2024 ( the antibody-drug conjugate (ADC) drug targeting epidermal growth factor receptor (EGFR) \\& human epidermal growth factor receptor 3 (HER3) )",[13],"Drug: HDM2024",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","ADC drug targeting EGFR and HER3",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Zhou Caicun","CONTACT","+8613301825532","caicunzhoudr@163.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Shanghai East Hospital","RECRUITING","Shanghai","Shanghai Municipality","200123","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":44,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100634407","phase-1-a-study-of-hdm2024-in-participants-with-advanced-solid-tumors-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":56,"type":57},63,"ESTIMATED","INTERVENTIONAL",[60],"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.",[63],"Advanced Solid Tumors",[65,66,67,68],"ADC","advanced solid tumors","EGFR","HER3","2026-04-13",{"date":71,"type":72},"2026-04-20","ACTUAL",{"date":74,"type":57},"2026-04-10",{"date":76,"type":57},"2028-12-28",{"name":5,"class":6},1]