[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622185":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":36,"locations":42,"responsibleParty":69,"collaborators":35,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":35,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":35,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":35,"overallStatus":45,"whyStopped":35,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",[8,14,17,20,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-1049 Group - Queue 1","EXPERIMENTAL","Specified dose on specified days.",[13],"Drug: SHR-1049 Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"SHR-1049 Group - Queue 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"SHR-1049 Group - Queue 3",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"SHR-1049 Group - Queue 4",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"SHR-1049 Group - Queue 5",[13],{"label":27,"type":10,"description":11,"interventionNames":28},"SHR-1049 Group - Queue 6",[13],[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","SHR-1049 Injection","SHR-1049 injection.",[9,15,18,21,24,27],null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Peng Xiu","CONTACT","+86-0518-82342973","peng.xiu@hengrui.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The First Affiliated Hospital of College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":52,"coordinates":53},"Point",[54,55],120.16142,30.29365,{"lat":55,"lon":54},[58,62,66,68],{"name":59,"role":39,"phone":60,"phoneExt":35,"email":61},"Tingbo Liang","+86-0571-87236688","liangtingbo@zju.edu.cn",{"name":63,"role":39,"phone":64,"phoneExt":35,"email":65},"Xueli Bai","+86-0571-87236857","shirleybai@zju.edu.cn",{"name":59,"role":67,"phone":35,"phoneExt":35,"email":35},"PRINCIPAL_INVESTIGATOR",{"name":63,"role":67,"phone":35,"phoneExt":35,"email":35},{"type":70,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100622185","phase-1-a-clinical-study-on-the-safety-tolerability-pharmacokinetics-and-efficacy-of-shr-1049-in-patients-with-advanced-solid-tumors-100622185",false,"NCT07380334","A Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 in Patients With Advanced Solid Tumors","An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with follow-up;\n2. Age range of 18-75 years old (including 18 and 75 years old, calculated on the day of signing informed consent), both male and female are eligible;\n3. Dose exploration stage: Participants with advanced or metastatic solid tumors diagnosed by tissue or cytological pathology who have failed standard treatment (disease progression or toxicity intolerance) or have no effective standard treatment;\n4. Stage of efficacy extension: Late stage or metastatic solid tumors diagnosed by tissue or cytological pathology;\n5. Able to provide sufficient fresh or archived tumor tissue specimens for third-party central laboratories designated by the sponsor to test expression levels; For participants who are unable to provide tumor tissue samples, the decision to enroll will be made after joint evaluation by the researchers and the sponsor;\n6. At least one measurable lesion that meets RECIST v1.1 criteria; Lesions that have undergone local treatment, if there is clear evidence of significant progression after treatment, can be selected as target lesions;\n7. ECOG PS score: 0 to 1;\n8. Expected survival period ≥ 12 weeks;\n9. The function of important organs meets the requirements;\n10. Female participants with fertility must have a negative serum HCG test within 7 days prior to their first medication and must be non lactating; Female participants with fertility must agree to use contraception and avoid egg donation for a period of 7 months from the signing of the informed consent form until the last administration of the investigational drug; Male participants whose partners are fertile women must agree to contraception and avoid donating sperm for a period of 4 months from the signing of the informed consent form until the last administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis; Participants with a history of meningeal metastasis or current meningeal metastasis;\n2. Imaging shows tumor invasion of large blood vessels or unclear boundary with blood vessels; Or it may be determined by researchers that the participant's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment;\n3. Previous or concurrent presence of other malignant tumors;\n4. Chest effusion, pericardial effusion, or abdominal effusion that is accompanied by clinical symptoms, difficult to control, or moderate or above; If fluid drainage is performed (excluding diagnostic puncture surgery), those who have been stable for at least 2 weeks after drainage can be included in the group;\n5. Interstitial pneumonia\u002Finterstitial lung disease, non infectious pneumonia (such as radiation pneumonitis) that previously required steroid treatment; Currently present or suspected of having interstitial pneumonia\u002Finterstitial lung disease, non infectious pneumonia, or other active pneumonia; Severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other lung damage occurred within 6 months prior to the first use of medication; Individuals with active pulmonary tuberculosis;\n6. Accompanied by poorly controlled or severe cardiovascular disease;\n7. Within one month prior to the first medication, there has been a bleeding event with NCI-CTCAE v5.0 grade ≥ 2;\n8. Those who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess within 3 months before the first medication;\n9. Symptoms and signs of gastrointestinal obstruction or gastrointestinal obstruction within 3 months prior to the first use of medication;\n10. Participants who have experienced a severe infection within one month prior to their first medication;\n11. History of immunodeficiency, including HIV test positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Participants known to have active hepatitis or active hepatitis C;\n12. Patients who have previously undergone surgery (excluding diagnostic surgery), radiotherapy, local treatment, chemotherapy, macromolecular targeted therapy, anti-tumor immunotherapy, and have completed treatment (last medication) less than 4 weeks after the first medication; Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) with less than 5 half lives or 4 weeks (whichever is shorter) between the last dose and the first dose;\n13. Previously received drug treatment with the same mechanism as the experimental drug;\n14. According to NCI-CTCAE v5.0 classification, those whose toxicity caused by previous anti-tumor therapy has not yet recovered to ≤ grade 1;\n15. Individuals known to be allergic to any component or other antibody drugs of SHR-1049 product;\n16. Those who have received attenuated live vaccine within 4 weeks before the first administration or are likely to receive attenuated live vaccine during treatment and within 60 days after the last administration;\n17. According to the researcher's judgment, there are other factors that may affect the research results or force the termination of this study midway.","ALL","18 Years","75 Years",{"count":82,"type":83},200,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","This study is a multicenter, open label, dose exploration\u002Fefficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors.",[89],"Advanced Solid Tumor","2026-04-15",{"date":92,"type":93},"2026-04-16","ACTUAL",{"date":95,"type":93},"2026-03-12",{"date":97,"type":83},"2028-12",{"name":5,"class":6},1]