[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hansoh BioMedical R&D Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":612},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,46,72,98,119,141,161,183,204,224,251,276,303,325,350,371,396,416,439,464,483,505,529,559,587],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100642510","phase-1-phase-1b-study-of-hs-20122-combined-therapy-in-nsclc-100642510",false,"NCT07645222","PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC","A PHASE Ib STUDY OF THE SAFETY, EFFICACY, PHARMACOKINETICS, AND IMMUNOGENICITY OF HS-20122 COMBINED THERAPY IN ADVANCED NON-SMALL CELL LUNG CANCER PATIENTS","Inclusion Criteria:\n\n1. Locally advanced or metastastic NSCLC;\n2. Received at least 1 line SoC,or treatment naïve;\n3. With at least 1 target lesion according to RECIST 1.1.\n4. Appropriate organ function\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.\n6. Minimum expected survival longer than 12 weeks\n7. Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.\n8. Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.\n\nExclusion Criteria:\n\n1. Insufficient wash out duration of prior systemic anticancer therapy\n2. Local radiotherapy within 2 weeks prior to first dose of investigational drug\n3. Pleural\u002Fabdominal effusion requires clinical intervention\n4. Major surgery within 4 weeks prior to first dose of investigational drug\n5. History of drugs may prolong QT interval\n6. Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).\n7. Presence of brain metastasis or carcinomatous meningtitis\n8. History of other primary malignancies\n9. Significant, uncontrolled, or active cardiovascular diseases\n10. Severe or poorly controlled diabetes\n11. Extremely obesity or emaciation\n12. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose\n13. Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose\n14. Severe infection within 4 weeks\n15. History of systemic glucocorticoids over 28 days prior to first dose of investigational drug\n16. Presence of known active infectious diseases,\n17. Prensence of ophthalmological abnormalities.\n\n17.Presence of hepatic encephalopathy, Hepato-renal Syndrome 18.Presence or history of confirmed or suspected ILD; 19.Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder.\n\n20.History of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs.\n\n21.Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.","ALL","18 Years","75 Years",{"count":21,"type":22},396,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).",[28],"Lung Cancer",[30,31,32,33],"Lung cancer","Tyrosine Kinase Inhibitor","Immuno-Checkpoint Inhibitor","Antibody Drug Conjugate","NOT_YET_RECRUITING","2026-06-08",{"date":37,"type":38},"2026-06-12","ACTUAL",{"date":40,"type":22},"2026-06-30",{"date":42,"type":22},"2029-04-30",{"name":44,"class":45},"Hansoh BioMedical R&D Company","INDUSTRY",{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100588080","phase-1-a-phase-i-study-of-hs-20108-in-participants-with-advanced-solid-tumors-100588080","NCT06936735","A Phase I Study of HS-20108 in Participants With Advanced Solid Tumors","A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20108 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Participants with pathologically confirmed advanced solid tumors.\n3. At least one measurable lesion in accordance with RECIST 1.1\n4. Fresh or archival tumor tissue available for submission.\n5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\\~1.\n6. Estimated life expectancy \\>12 weeks.\n7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.\n8. Females must have evidence of non-childbearing potential.\n9. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n1. Treatment with any of the following:\n\n   Having received cytotoxic chemotherapy agents, investigational drugs, Chinese medicine treatment with anti-tumor indications, or other anti-tumor therapy (including endocrine therapy, molecular targeted therapy, or biotherapy) within 14 days before the first dose of study treatment.\n\n   Having received macromolecular anti-tumor drug therapy (including immunotherapy, such as monoclonal antibody drugs and bispecific antibody drugs) within 28 days before the first dose of study treatment.\n\n   Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.\n\n   Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.\n2. Inadequate bone marrow reserve or serious organ dysfunction.\n3. Uncontrolled pleural effusion or ascites or pericardial effusion.\n4. Known and untreated, or active central nervous system metastases.\n5. Active autoimmune diseases or active infectious disease\n6. Known to have interstitial pneumonia or immune pneumonia\n7. History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108\n8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.\n9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.\n10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.\n11. History of neuropathy or mental disorders, including epilepsy and dementia.",{"count":54,"type":22},502,[25],"This is a Phase I clinical study of HS-20108. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of intravenous HS-20108 in patients with advanced solid tumors.",[58],"Advanced Solid Tumor",[60,61],"small cell lung cancer","neuroendocrine carcinoma","RECRUITING","2026-05-31",{"date":65,"type":38},"2026-06-02",{"date":67,"type":38},"2025-05-29",{"date":69,"type":22},"2029-02-28",{"name":44,"class":45},1,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100637133","phase-3-a-study-of-hs-20093-in-patients-with-pretreated-advanced-or-metastatic-esophageal-squamous-cell-carcinoma-escc-100637133","NCT07621601","A Study of HS-20093 in Patients With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)","A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093- Injection Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Progress of First-Line Standard Therapy","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex.\n2. Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.\n3. Patients with histologically or cytologically confirmed diagnosis of advanced recurrent or metastatic esophageal squamous cell carcinoma (ESCC), progressed after receiving first-line standard treatment.\n4. Presence of at least one target lesion according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.\n6. Minimum life expectancy \\>12 weeks.\n7. Adequate organ function.\n8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.\n9. Female patients with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.\n\nExclusion Criteria:\n\n* 1\\. Prior pathological diagnosis of esophageal adenocarcinoma, esophageal adenoid cystic carcinoma, esophageal mucoepidermoid carcinoma, esophageal undifferentiated carcinoma, esophageal neuroendocrine carcinoma, or esophageal mixed carcinoma 2. Prior or ongoing treatment with any of the following:\n\n  1. Prior or current treatment targeting B7-H3;\n  2. Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression.\n\n     5\\. History of other primary malignancies. 6. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 7. Severe or poorly controlled hypertension and diabetes mellitus. 8. Tumors have the risk of leading perforation\u002Ffistula, hemorrhage, or obstruction.\n\n     9\\. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.\n\n     10\\. Known to have allergic reactions or contraindications to the investigational medicinal product.",{"count":80,"type":22},494,[82],"PHASE3","This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093- injection versus investigator's choice of chemotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma after progress of first-line standard therapy.",[85],"Esophageal Squamous Cell Carcinoma (ESCC)",[87,88,89,90],"ESCC","HS-20093","advanced","metastatic","2026-05-26",{"date":65,"type":38},{"date":94,"type":22},"2026-07-31",{"date":96,"type":22},"2032-12-31",{"name":44,"class":45},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":71},"100614728","phase-1-a-phase-ibii-trial-of-hs-20110-combination-therapies-in-advanced-colorectal-cancer-patients-100614728","NCT07283367","A Phase Ib\u002FII Trial of HS-20110 Combination Therapies in Advanced Colorectal Cancer Patients.","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 Combination Therapies in Patients With Advanced Colorectal Cancer.","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Participants with pathologically confirmed advanced Colorectal Cancer.\n* Participants have at least 1 target lesion other than CNS lesions according to RECIST 1.1.\n* MSI was tested to be non-MSI-H, and without BRAF V600E mutation.\n\nExclusion Criteria:\n\n* Participants have received or are receiving the following treatment:\n\n  1. 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  2. 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  3. Major surgery within 4 weeks prior to the first dose of study treatment.\n  4. 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  5. 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  6. Live vaccine or live-attenuated vaccine within 28 weeks prior to the first dose.\n* Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior therapies (except alopecia and residual neurotoxicity).\n* Inadequate bone marrow reserve or hepatic and renal functions.\n* Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.\n* Participants who are allergic to any component of HS-20110 combination therapies.",{"count":54,"type":22},[25,107],"PHASE2","This is a multicenter, open-label Phase Ib\u002FII clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of the HS-20110 combination therapies in Patients with Advanced Colorectal Cancer. \"Rolling 6\" design would be used to conduct dose escalation part of this study. This study consists of phase Ib and phase II. After RP2D was determined in phase Ib, then a phase II study will be conducted to further evaluate the efficacy, safety, tolerability, and PK of the HS-20110 combination therapies in Patients with mCRC.",[110],"CRC","2026-04-27",{"date":113,"type":38},"2026-05-01",{"date":115,"type":38},"2025-12-22",{"date":117,"type":22},"2029-12-31",{"name":44,"class":45},{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100584671","phase-1-a-study-of-hs-20110-in-participants-with-advanced-solid-tumors-100584671","NCT06892379","A Study of HS-20110 in Participants With Advanced Solid Tumors","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20110 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\nExclusion Criteria:\n\n1. Participants have received or are receiving the following treatment:\n\n   1. Drug therapy targeting CDH17 (such as small molecule targeted drugs, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, or chimeric antigen receptor T cells).\n   2. 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   3. 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   4. Major surgery within 4 weeks prior to the first dose of study treatment.\n   5. 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   6. 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   7. 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 5.0) from prior therapies (except alopecia and residual neurotoxicity).\n3. Inadequate bone marrow reserve or hepatic and renal functions.\n4. Participants with a history of severe allergy (such as anaphylactic shock), previous severe infusion reactions, or allergy to recombinant human or murine proteins.\n5. Participants who are allergic to any component of HS-20110.",{"count":127,"type":22},475,[25],"This is an open-label, multicenter study to evaluate the safety and tolerability of HS-20110 in participants with advanced solid malignant tumors",[131],"Solid Tumors","2026-04-17",{"date":134,"type":38},"2026-04-20",{"date":136,"type":38},"2025-02-26",{"date":138,"type":22},"2027-09-30",{"name":44,"class":45},8,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":160,"locationsCount":4},"100628644","phase-3-a-phase-iii-study-of-hs-20093-injection-combined-with-adebrelimab-versus-docetaxel-in-previously-treated-patients-with-advanced-or-metastatic-non-squamous-non-small-cell-lung-cancer-without-actionable-genomic-alterations-100628644","NCT07464327","A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations","A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations","Inclusion Criteria:\n\n1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex.\n2. Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.\n3. Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).\n4. Presence of at least one measurable target lesion.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.\n6. Minimum life expectancy \\>12 weeks.\n7. Adequate organ function.\n8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.\n9. Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.\n\nExclusion Criteria:\n\n1. Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.\n2. Prior or ongoing treatment with any of the following:\n\n   1. Prior or current treatment targeting B7-H3;\n   2. Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.;\n   3. Prior treatment with docetaxel monotherapy or in combination with other agents.\n3. Persistent adverse reactions caused by prior treatment.\n4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).\n5. History of other primary malignancies.\n6. Presence of any of the following abnormal cardiac findings:\n\n   1. Evidence of currently clinically significant important arrhythmia or ECG abnormality;\n   2. Presence of risk factors causing QT interval prolongation or arrhythmic events.\n7. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.\n8. Severe or poorly controlled hypertension.\n9. Severe or poorly controlled diabetes mellitus.\n10. Clinically significant bleeding symptoms or significant bleeding tendency.\n11. Severe infection.\n12. History of severe arterial or venous thromboembolic events.\n13. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.\n14. Participants with active or history of autoimmune disease with potential for recurrence.\n15. Prior occurrence of severe or life-threatening immune-mediated adverse events.",{"count":149,"type":22},450,[82],"This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.",[153],"Non-Small Cell Lung Cancer","2026-03-06",{"date":156,"type":38},"2026-03-11",{"date":158,"type":22},"2026-03-31",{"date":117,"type":22},{"name":44,"class":45},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":71},"100628537","phase-1-hs-20093-in-patients-with-advanced-gastric-and-gastroesophageal-junction-adenocarcinoma-100628537","NCT07462923","HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","A Phase Ib Clinical Study on the Efficacy, Safety, Tolerability, and Pharmacokinetics of HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. At least age of 18 years at screening, with no restrictions on gender.\n2. Signed and dated Informed Consent Form.\n3. Participants with pathologically or cytologically confirmed locally advanced unresectable or metastatic GC\u002FGEJC, who have failed, or intolerant to standard therapies.\n4. At least one extra measurable lesion according to RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n6. Estimated life expectancy \\>12 weeks.\n7. Agree to provide fresh or archival tumor tissue.\n8. Good organ function.\n9. Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n10. Men or women should be using adequate contraceptive measures throughout the study.\n\nExclusion Criteria:\n\n1. Treatment with any of the following:\n\n   * Previous or current treatment with B7-H3 targeted therapy.\n   * Previous or current treatment with topoisomerase I inhibitors.\n   * Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093\n   * Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093\n   * Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093\n   * Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.\n   * Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.\n2. Histology shows squamous cell carcinoma, undifferentiated carcinoma, or mixed tumors , such as adenosquamous carcinoma or other mixed tumors.\n3. Any unresolved toxicities from prior therapy greater than Grade 1 according to CTCAE 5.0 or baseline status.\n4. Presence of pleural effusion\u002Fascites requiring clinical intervention.\n5. Newly diagnosed brain metastases without treatment, or brain metastases that have not achieved stability despite treatment; presence of leptomeningeal metastasis or brainstem metastasis; presence of spinal cord compression.\n6. History of other primary malignancies\n7. Evidence of cardiovascular risk.\n8. Severe, uncontrolled or active cardiovascular diseases.\n9. Severe or poorly controlled hypertension.\n10. Severe or poorly controlled diabetes.\n11. Poorly controlled cancer-related pain.\n12. The presence of active infectious diseases has been known: hepatitis B, hepatitis C and HIV.\n13. Major surgery within 4 weeks prior to the first scheduled dose of HS-20093.\n14. Active infection requiring therapeutic intravenous antibiotics within 2 weeks prior to the first dose.\n15. Clinically significant bleeding symptoms or marked hemorrhagic tendency within 1 month prior to the first dose of HS-20093.\n16. Serious arterial or venous thromboembolic events occurring within 3 months prior to the first dose of HS-20093.\n17. Active tuberculosis.\n18. History of known interstitial pneumonia or immune-mediated pneumonitis.\n19. History of active or prior autoimmune disease requiring systemic treatment.\n20. Severe malnutrition.\n21. Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.\n22. Requires long-term glucocorticoid therapy.\n23. Having undergone any major surgery within 4 weeks prior to the first dose.\n24. Vaccination within 4 weeks prior to the first dose of HS-20093.\n25. History of severe allergy.\n26. Previous history of serious neurological or mental disorders. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n27. Currently enrolled in or participating in any other clinical study involving investigational interventions or other types of interventional medical research.",{"count":169,"type":22},40,[25],"HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells.\n\nThis is a phase 1b, open-label, multi-center study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HS-20093 in patients with advanced gastric and gastroesophageal junction adenocarcinoma.",[173],"Advanced Gastric and Gastroesophageal Junction Adenocarcinoma",[175,88],"Gastric and Gastroesophageal Junction Adenocarcinoma",{"date":177,"type":38},"2026-03-10",{"date":179,"type":38},"2026-01-29",{"date":181,"type":22},"2028-03-31",{"name":44,"class":45},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":71},"100607276","phase-1-evaluation-of-the-effect-of-itraconazole-on-the-pharmacokinetics-of-hs-20093-in-patients-with-advanced-solid-tumors-100607276","NCT07186452","Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors","A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors Who Have Failed Adequate Standard Treatments or Are Intolerant to Standard Therapies","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced solid tumors that have failed standard therapy or are intolerant to standard treatment.\n2. According to RECIST 1.1 criteria, participants must have at least one target lesion.\n3. ECOG performance status score of 0-1 with no deterioration within 2 weeks prior to the first dose.\n4. Minimum expected survival greater than 12 weeks.\n\nExclusion Criteria:\n\n1. Patients with a contraindication for receiving itraconazole according to the prescribing information\n2. Patients with severe, uncontrolled, or active cardiovascular diseases",{"count":191,"type":22},18,[25],"The primary objective of this study is to evaluate the effect of itraconazole on the pharmacokinetics of HS-20093 in patients with advanced solid tumors.",[195],"Advanced Solid Tumors","2026-01-15",{"date":198,"type":38},"2026-01-16",{"date":200,"type":38},"2025-09-23",{"date":202,"type":22},"2026-08-31",{"name":44,"class":45},{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":71},"100587375","phase-1-a-study-of-hs-20122-in-patients-with-advanced-solid-tumors-100587375","NCT06927570","A Study of HS-20122 in Patients With Advanced Solid Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Males or females, aged ≥ 18 years.\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors\n* Standard treatment is invalid, unavailable or intolerable.\n* At least 1 target lesion according to RECIST 1.1.\n* ECOG PS score: 0-1.\n* Estimated Life expectancy\\> 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study.\n* Women must have the evidence of non-childbearing potential.\n* Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Evidence of cardiovascular risk.\n* Subjects with severe or poorly controlled diabetes.\n* Subjects with severe or poorly controlled hypertension.\n* Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n* Subjects with severe arteriovenous thrombotic events within 3 months.\n* Subjects with severe infection within 4 weeks prior to the first dose.\n* Subjects who have received steroid therapy for more than 30 days .\n* Presence of known active infectious diseases.\n* Presence of clinically significant gastrointestinal dysfunction.\n* Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Hypersensitivity to any ingredient of HS-20122.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Evidence of cardiovascular risk.\n* Subjects with severe or poorly controlled diabetes.\n* Subjects with severe or poorly controlled hypertension.\n* Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose.\n* Subjects with severe arteriovenous thrombotic events within 3 months.\n* Subjects with severe infection within 4 weeks prior to the first dose.\n* Subjects who have received steroid therapy for more than 30 days .\n* Presence of known active infectious diseases.\n* Presence of clinically significant gastrointestinal dysfunction.\n* Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B.\n* Moderate to severe pulmonary diseases.\n* Prior history of significant neurological or mental disorders.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n* Hypersensitivity to any ingredient of HS-20122.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments",{"count":212,"type":22},1050,[25],"This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.",[195],[195,217],"HS-20122",{"date":198,"type":38},{"date":220,"type":38},"2025-04-15",{"date":222,"type":22},"2028-06-30",{"name":44,"class":45},{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":231,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":71},"100581804","phase-3-hs-20089-for-injection-in-patients-with-platinum-resistant-recurrent-epithelial-ovarian-cancer-100581804","NCT06855069","HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer","A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. Voluntary participation and written informed consent.\n2. 18 years and older, female.\n3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n4. Patients must have platinum-resistant disease\n5. Be able to provide fresh or archived tumor tissue.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.\n8. With a life expectancy \\> 12 weeks.\n9. Adequate bone marrow reserve and organ function.\n10. Contraception is required during the trial.\n\nExclusion Criteria:\n\n1. Prior treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.\n2. Previous or co-existing malignancies.\n3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.\n4. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.\n5. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.\n6. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of HS-20089.\n7. Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with the study participation or study drug administration.\n8. Other inappropriate situation considered by the investigator.","FEMALE",{"count":233,"type":22},468,[82],"This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of HS-20089 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.",[237],"Ovarian Cancer",[239,240,241,242],"Platinum-resistant recurrent epithelial ovarian cancer","HS-20089","randomized","phase III","2025-12-15",{"date":245,"type":38},"2025-12-17",{"date":247,"type":38},"2025-03-13",{"date":249,"type":22},"2029-03-07",{"name":44,"class":45},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":258,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":71},"100601818","phase-1-phase-ib-study-of-hs-20093hrs-5041-in-patients-with-advanced-prostate-cancer-100601818","NCT07115446","Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer","A Phase Ib Study to Explore the Safety, Tolerability, and Pharmacokinetics of HS-20093 Combination With HRS-5041 in Patients With Advanced Prostate Cancer","Inclusion Criteria:\n\n* Men greater than or equal to 18 years.\n* Voluntarily to participate, Signed and dated Informed Consent Form.\n* Patients with metastatic castration-resistant prostate cancer (mCRPC) who progressed after at least one type of novel hormonal therapy (standard treatment).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n* Estimated life expectancy ≥ 12 weeks.\n* Men should use adequate contraceptive measures throughout the study, up to 3 months after the last dose of HRS-5041 or 4.5 months after the last dose of HS-20093 (whichever is later).\n\nExclusion Criteria:\n\n* Treatment with any of the following:\n\n  a. Previous or current treatment with B7-H3 targeted therapy. b. Previous treatment with AR PROTAC. c. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 21 days prior to the first scheduled dose of HS-20093+HRS-5041. d. brain metastases.\n* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0.\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction.\n* Severe, uncontrolled or active cardiovascular diseases.\n* Severe or uncontrolled diabetes.\n* The presence of active infectious diseases.\n* Any known or suspected interstitial lung disease.\n* History of serious neuropathy or mental disorders.\n* History of severe hypersensitivity reaction, severe infusion reaction.\n* Hypersensitivity to any ingredient of HS-20093.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator.\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.","MALE",{"count":260,"type":22},63,[25],"HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. HRS-5041 is a Proteolysis Targeting Chimeras (PROTAC) targeting androgen receptors.\n\nThis is a phase Ib, open-label, multi-center study to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-20093 combination with HRS-5041 in patients with advanced prostate cancer.",[264],"Advanced Prostate Cancer",[266,267,88],"Advanced prostate cancer","B7H3","2025-11-28",{"date":270,"type":38},"2025-12-05",{"date":272,"type":38},"2025-08-19",{"date":274,"type":22},"2028-12",{"name":44,"class":45},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"100548131","phase-2-a-study-of-hs-20117-combined-with-aumolertinib-in-participants-with-advanced-non-squamous-non-small-cell-lung-cancer-100548131","NCT06417008","A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","A Phase Ib\u002FIII Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Males or females aged 18 - 75 years (inclusive).\n* Participants with newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB\u002FIIIC\u002FIV) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.\n* Agree to provide fresh or archival tumor tissue.\n* At least one target lesion per the RECIST v1.1.\n* ECOG performance status of 0-1.\n* Minimum life expectancy \\> 12 weeks.\n* Males or Females should be using adequate contraceptive measures throughout the study.\n* Females must not be pregnant at screening or have evidence of non-childbearing potential.\n* Have signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Received or are receiving the following treatments:\n\n  1. Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC).\n  2. Traditional Chinese medicine indicated for tumors, major surgery or other local therapy within washout period to the first dose of study drug.\n  3. Presence of pleural effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion.\n  4. Other investigational non-anti-tumor drugs, strong CYP3A4 inhibitors, strong inducers, drugs that are sensitive substrates of BCRP or P-gp, or drugs that prolong the QT interval within the washout period.\n* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.\n* History of other primary malignancies.\n* Untreated, or active central nervous system metastases.\n* Inadequate bone marrow reserve or organ functions.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Severe or uncontrolled systemic diseases.\n* Severe bleeding symptoms or bleeding tendencies.\n* Severe arteriovenous thrombosis occurred.\n* Serious or active infection.\n* Active infectious diseases.\n* Interstitial lung disease (ILD).\n* Serious neurological or mental disorders.\n* History of hypersensitivity to any component of HS-20117 and Aumolertinib or their similar drugs.\n* Female subjects who are pregnant, lactating, or planning to become pregnant or breastfeed during the study period or within 6 months after the last dose of the study drug.\n* Subjects with a history of severe allergic reactions or those who have experienced severe infusion reactions\n* Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.",{"count":284,"type":22},1080,[107,82],"HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \\[Exon 19del\\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).",[288],"Non-Squamous Non-Small Cell Lung Cancer",[153,290,291,292,293],"HS-20117","Epidermal Growth Factor Receptor","c-Mesenchymal-Epithelial Transition","Bispecific Antibody","2025-07-30",{"date":296,"type":38},"2025-08-01",{"date":298,"type":38},"2024-05-28",{"date":300,"type":22},"2030-06-01",{"name":44,"class":45},2,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":71},"100587299","phase-2-a-study-to-evaluate-efficacy-and-safety-of-hs-10374-for-mild-to-moderate-plaque-psoriasis-100587299","NCT06926582","A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis","A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate Clinical Efficacy and Safety of HS-10374 in Adult Patients With Mild-to-moderate Plaque Psoriasis","Inclusion Criteria:\n\n1. Male or female subjects between the ages of 18-70 years\n2. Diagnosis of plaque psoriasis for at least 6 months\n3. sPGA score of 2-3, BSA 2-15%, PASI score 2-15\n4. Subject must be inadequately controlled with, or intolerant of at least one topical therapy\n\nExclusion Criteria:\n\n1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis\n2. Recent history of infection, history or risk of serious infection\n3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease\n4. Any condition possibly affecting the PK process of the study drug\n5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis\n6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis\n7. Prior exposure to TYK2 inhibitors\n8. Have received the prohibited treatment during the protocol required washout period\n9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period","70 Years",{"count":312,"type":22},305,[107],"This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.",[316],"Psoriasis","2025-04-10",{"date":319,"type":38},"2025-04-13",{"date":321,"type":22},"2025-04-09",{"date":323,"type":22},"2026-12-09",{"name":44,"class":45},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":290,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":71},"100563853","phase-1-phase-ib-trial-of-hs-20117-in-combination-with-other-drugs-in-advanced-solid-tumors-100563853","NCT06621563","Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors","Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial","Inclusion Criteria:\n\n* Males or females aged 18 - 75 years (inclusive).\n* Histologically confirmed unresectable, recurrent or metastatic solid tumors.\n* At least one target lesion per the RECIST v1.1.\n* ECOG performance status of 0-1.\n* Minimum life expectancy \\> 12 weeks.\n* Males or Females should be using adequate contraceptive measures throughout the study.\n* Females must not be pregnant at screening or have evidence of non-childbearing potential.\n* Signed Informed Consent Form.\n\nExclusion Criteria:\n\n* Received or are receiving the following treatments:\n\n  1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.\n  2. Monoclonalor bispecific antibodies targeting EGFR.\n  3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.\n  4. Investigational anti-cancer drugs or antibodies or ADCs within 4 weeks prior to the first dose of HS-20117.\n  5. Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117.\n  6. Presence of pleural effusion\u002Fascites requiring clinical intervention; presence of pericardial effusion.\n  7. Major surgery within 4 weeks prior to the first dose of HS-20117.\n* Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.\n* Presence of uncured secondary primary malignancies.\n* Untreated, or active central nervous system metastases.\n* Severe, uncontrolled or active cardiovascular disorders.\n* Serious infection within 4 weeks prior to the first dose of HS-20117.",{"count":333,"type":22},780,[25],"HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.",[131,153,337],"Colorectal Cancer",[339,340,341,342],"Solid tumor","EGFR\u002Fc-MET bispecific antibody","B7H3 ADC","chemotherapy","2025-04-07",{"date":321,"type":38},{"date":346,"type":38},"2024-12-14",{"date":348,"type":22},"2026-12-01",{"name":44,"class":45},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":4},"100581014","phase-3-a-study-of-hs-20137-in-participants-with-moderate-to-severe-plaque-psoriasis-100581014","NCT06844799","A Study of HS-20137 in Participants with Moderate-to-severe Plaque Psoriasis","A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate Efficacy and Safety of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants with Moderate-to-severe Plaque Psoriasis","Inclusion Criteria:\n\n1. Adults aged 18 and above, male or female;\n2. Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;\n3. During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥10%; b) PASI≥12; c) sPGA≥3;\n4. Suitable for systemic therapy or phototherapy;\n5. Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Previous use of biological agents, or allergic reactions to known drug ingredients, or previous severe food or drug allergies;\n2. Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation of psoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs, antimalarial drugs, interferon, calcium channel blockers, or lithium induced psoriasis) from the screening period to the time before randomization;\n3. Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis, etc., assessed by the investigator and other factors that may affect the efficacy evaluation or assessed by other researchers before randomization;\n4. Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23 target investigatory drugs under development) (the minimum treatment standard was not reached 12 weeks after the first treatment);\n5. Use of the following drugs before randomization:\n\n   1. Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before randomization;\n   2. 4 weeks before randomization, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;\n   3. use of TNF-α biologics within 3 months prior to randomization;\n   4. use of other biologics for the treatment of psoriasis within 6 months before randomization; e) Use of oral or topical proprietary Chinese medicinesor other Chinese herbal medicines that affect or may affect the evaluation of psoriasis within 4 weeks prior to randomization;\n\n   f) use of lymphocyte migration regulators or B cell and T cell regulators within 3 months before randomization, or 6 months before screening, (whichever is older) use of B-cell-specific scavenging drugs;\n6. A history of chronic recurrent infection, or opportunistic infection in the 6 months prior to screening, or hospitalization for a serious infectious disease or intravenous antibiotic use in the 2 months prior to randomization, with a confirmed or suspected illness in the 1 week prior to randomization. And Other circumstances determined by the investigator to be unsuitable for further study participation.",{"count":358,"type":22},720,[82],"The primary objective of this study is to evaluate the efficacy and safety of HS-20137 in the treatment of participants with moderate to severe plaque psoriasis.",[362],"Moderate-to-severe Plaque Psoriasis","2025-02-19",{"date":365,"type":38},"2025-02-25",{"date":367,"type":22},"2025-06-10",{"date":369,"type":22},"2027-06-30",{"name":44,"class":45},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":71},"100579540","phase-1-artemis-102-hs-20093-combinations-in-patients-with-advanced-metastatic-colorectal-cancer-100579540","NCT06825624","ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer","ARTEMIS-102: a Phase Ib Study of HS-20093 Combination Therapy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* At least age of 18 years at screening.\n* Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer.\n\n  1. Dose escalation part will enroll advanced metastatic colorectal cancer patients who have progressed on or intolerant to standard therapies.\n  2. Dose expansion part will enroll advanced metastatic colorectal cancer patients who have not received prior treatment for advanced\u002Fmetastatic colorectal cancer.\n* At least one measurable lesion according to RECIST 1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n* Life expectancy \\>= 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study.\n* Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n* Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n* Treatment with any of the following:\n\n  1. Previous or current treatment with B7-H3 targeted therapy or ADCs with topoisomerase I inhibitors as the payload\n  2. Any cytotoxic chemotherapy, investigational agents and small molecule targeted therapy within 14 days prior to the first scheduled dose of HS-20093\n  3. Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs within 28 days prior to the first scheduled dose of HS-20093\n  4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093\n  5. Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion\n  6. Major surgery within 4 weeks of the first dose of HS-20093\n  7. Spinal cord compression or brain metastases.\n  8. Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.\n  9. Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.\n* Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of stable hypothyroidism treated with hormone replacement therapy, alopecia or neurotoxicity.\n* History of other primary malignancies.\n* Inadequate bone marrow reserve or organ dysfunction\n* Evidence of cardiovascular risk.\n* Severe, uncontrolled or active cardiovascular diseases.\n* Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug.\n* Severe or poorly controlled hypertension.\n* Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093\n* Serious arteriovenous thrombosis events occurred within 3 months before the first dose.\n* Severe infections occurred within 4 weeks before the first dose.\n* Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation\n* The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.\n* Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.\n* Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n* Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment.\n* Women who are breastfeeding or pregnant or planned to be pregnant during the study period.\n\n  18\\. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093\n* History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.\n* Hypersensitivity to any ingredient of HS-20093.\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments",{"count":379,"type":22},560,[25],"HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and efficacy of HS-20093 in combination with other anti-cancer agents in patients with advanced metastatic colorectal cancer.",[383],"Metastatic Colorectal Cancer (CRC)",[385,386,387,88],"Metastatic Colorectal Cancer (mCRC)","B7-H3","antibody-drug conjugate (ADC)","2025-02-09",{"date":390,"type":38},"2025-02-13",{"date":392,"type":38},"2024-10-03",{"date":394,"type":22},"2026-12-31",{"name":44,"class":45},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":71},"100574736","phase-1-a-study-of-hs-20124-in-patients-with-advanced-solid-tumors-100574736","NCT06763159","A Study of HS-20124 in Patients with Advanced Solid Tumors","A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20124 in Patients with Advanced Solid Tumors","Inclusion Criteria:\n\n1. At least age of 18 years at screening;\n2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable\n3. At least one extra-cranial measurable lesion according to RECIST 1\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1\n5. Life expectancy \\>= 12 weeks\n6. Men or women should be using adequate contraceptive measures throughout the study;\n7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential\n8. Signed and dated Informed Consent Form\n\nExclusion Criteria:\n\n1.Treatment with any of the following:\n\n1. Previous or current treatment with CDH6 targeted therapy\n2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124\n3. Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124\n4. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20124\n5. Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124",{"count":149,"type":22},[25],"HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.",[407],"Solid Cancer","2025-01-01",{"date":410,"type":38},"2025-01-08",{"date":412,"type":38},"2024-10-30",{"date":414,"type":22},"2027-12-31",{"name":44,"class":45},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":23,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":437,"locationsCount":438},"100524743","phase-2-hs-20093-in-patients-with-advanced-esophageal-carcinoma-and-other-advanced-solid-tumors-100524743","NCT06112704","HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors","A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.\n3. At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).\n4. Agree to provide fresh or archival tumor tissue and blood samples.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1.\n6. Estimated life expectancy \\>12 weeks.\n7. Agree to use medically accepted methods of contraception.\n8. Men or women should be using adequate contraceptive measures throughout the study.\n9. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n10. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\nAny of the following would exclude the subject from participation in the study:\n\n1. Treatment with any of the following:\n\n   Previous or current treatment with B7-H3 targeted therapy Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093\n2. Subjects with previous or concurrent malignancies\n3. Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula\n4. Inadequate bone marrow reserve or organ dysfunction.\n5. Evidence of cardiovascular risk\n6. Evidence of current severe or uncontrolled systemic diseases\n7. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093\n8. Severe infections occured within 4 weeks before the first dose\n9. The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect\n10. History of neuropathy or mental disorders\n11. Pregnant or lactating female\n12. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093\n13. Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093\n14. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n15. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments",{"count":424,"type":22},220,[107],"HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.",[58],[429,430,386,387,88],"Advanced solid tumor","Esophageal Carcinoma","2024-11-27",{"date":433,"type":38},"2024-12-02",{"date":435,"type":38},"2024-02-06",{"date":394,"type":22},{"name":44,"class":45},21,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":4},"100569848","phase-1-artemis-103-phase-1b-study-of-hs-20093-combinations-in-patients-with-bone-and-soft-tissue-sarcoma-100569848","NCT06699576","ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.","ARTEMIS-103: a Phase 1b, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination with Other Anti-cancer Agents in Patients with Bone and Soft Tissue Sarcoma.","Inclusion Criteria:\n\n* At least age of 18 years at screening;\n* Histologically or cytologically confirmed, locally advanced or metastatic osteosarcoma and soft tissue sarcoma\n\n  1. Cohort1: Dose escalation part will enroll advanced soft tissue sarcoma for which standard treatment has proven ineffective or unavailable or intolerable. Dose expansion part will enroll patients who have not received prior treatment for advanced\u002Fmetastatic disease.\n  2. Cohort2: Advanced osteosarcoma patients for which standard treatment has proven ineffective or unavailable or intolerable.\n* least one extra-cranial measurable lesion according to RECIST 1\n* Agree to provide fresh or archival tumor tissue\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\\~1\n* Life expectancy \\>= 12 weeks\n* Agree to use medically accepted methods of contraception\n* Men or women should be using adequate contraceptive measures throughout the study;\n* Females subjects must not be pregnant at screening or have evidence of non-childbearing potential\n* Signed and dated Informed Consent Form\n\nExclusion Criteria:\n\n* treatment with any of the following:\n\n  1. Previous or current treatment with B7-H3 targeted therapy\n  2. Previous or current treatment with TOP1i related treatment\n  3. Previous or current treatment with PD-L1 inhibitor (Cohort2 )\n  4. Intolerable for any Anlotinib(Cohort 1a\u002F1c), Anthracyclines (Cohort 1b\u002F1c) and PD-L1 inhibitor (Cohort2 )\n  5. Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093\n  6. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093\n  7. Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093\n  8. Major surgery within 4 weeks prior to the first scheduled dose of HS-20093\n* Subjects with previous or concurrent malignancies\n* Inadequate bone marrow reserve or organ dysfunction\n* Evidence of cardiovascular risk\n* Evidence of current severe or uncontrolled systemic diseases\n* Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093\n* Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093\n* Subjects with current infectious diseases\n* History of neuropathy or mental disorders\n* Pregnant or lactating female\n* History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093\n* Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator\n* Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments",{"count":447,"type":22},448,[25],"HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on bone and soft tissue sarcoma. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced bone and soft tissue sarcoma.",[451,452],"Osteosarcoma","Soft Tissue Sarcoma (STS)",[454,451,455,88,386],"Phase 1b","Soft Tissue Sarcoma","2024-11-19",{"date":458,"type":38},"2024-11-21",{"date":460,"type":22},"2024-12-20",{"date":462,"type":22},"2028-12-30",{"name":44,"class":45},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":480,"leadSponsor":482,"locationsCount":71},"100567761","phase-3-a-study-to-confirm-efficacy-and-safety-of-hs-10374-for-moderate-to-severe-plaque-psoriasis-100567761","NCT06672393","A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis","A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis","Inclusion Criteria:\n\n* Male or female subjects aged 18 years and older\n* Diagnosis of plaque psoriasis for at least 6 months\n* Eligible for phototherapy or systemic therapy\n* Plaque covering ≥ 10% of BSA\n* PASI ≥ 12, sPGA ≥3\n\nExclusion Criteria:\n\n* Diagnosis of non-plaque psoriasis or drug-induced psoriasis\n* Recent history of infection, history or risk of serious infection\n* Any major illness or evidence of unstable condition of major organ systems including psychiatric disease\n* Any condition possibly affecting the PK process of the study drug\n* Evidence of other skin conditions that would interfere with the evaluation of psoriasis\n* History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis\n* Prior exposure to TYK2 inhibitors\n* Have received the prohibited treatment during the protocol required washout period\n* Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period",{"count":472,"type":22},375,[82],"This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.",[316],"2024-10-31",{"date":478,"type":38},"2024-11-04",{"date":478,"type":22},{"date":481,"type":22},"2026-06-29",{"name":44,"class":45},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":504},"100554391","phase-3-artemis-008hs-20093-compared-with-topotecan-in-subjects-with-relapsed-small-cell-lung-cancer-100554391","NCT06498479","ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer","ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy","Inclusion Criteria:\n\n1. Male or female subjects ≥18 years of age.\n2. Histologically or cytologically confirmed SCLC.\n3. Subjects who progressed on or after first-line platinum-based regimens.\n4. Has at least 1 measurable lesion as defined per RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n6. Minimum life expectancy of more than 12 weeks.\n7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n8. Men or women should be using adequate contraceptive measures throughout the study.\n9. Subject has provided informed consent\u002Fassent prior to initiation of any study specific activities\u002Fprocedures.\n\nExclusion Criteria:\n\n1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.\n2. Chemotherapy-free interval ≤30 days.\n3. Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.\n4. Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.\n5. Has inadequate washout period before randomization as specified in the protocol.\n6. Untreated or symptomatic brain metastases with exceptions defined in the protocol.\n7. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.\n8. History of other malignancy with exceptions defined in the protocol.\n9. Inadequate bone marrow reserve or organ dysfunction.\n10. Evidence of cardiovascular risks.\n11. Severe, uncontrolled or active cardiovascular diseases.\n12. Severe or uncontrolled diabetes.\n13. Severe or uncontrolled high blood pressure.\n14. Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.\n15. Severe arterial or venous thromboembolic events within 3 months prior to randomization.\n16. Severe infections within 4 weeks before randomization.\n17. Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.\n18. The presence of active infectious diseases before randomization.\n19. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.\n20. History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.\n21. History of severe neuropathy or mental disorders.\n22. Female subjects of childbearing potential; female subjects who are breastfeeding or who plan to breastfeed while on study; female subjects planning to become pregnant while on study.\n23. Vaccination or hypersensitivity of any level within 4 weeks before randomization.\n24. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.\n25. Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.",{"count":491,"type":22},460,[82],"The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).",[495],"Small Cell Lung Cancer","2024-10-15",{"date":498,"type":38},"2024-10-16",{"date":500,"type":38},"2024-07-04",{"date":502,"type":22},"2027-05-31",{"name":44,"class":45},9,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":23,"phases":515,"briefSummary":516,"conditions":517,"keywords":519,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":71},"100564945","phase-2-a-study-of-the-effect-and-safety-of-hs-10390-in-the-treatment-of-patients-with-primary-iga-nephropathy-100564945","NCT06635772","A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy","A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy","Inclusion Criteria:\n\n* Male or female, between 18 and 65 years age.\n* Biopsy-proven primary IgA nephropathy.\n* Currently on stable dose of ACEI and\u002For ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).\n* Average 24-hour urine total protein ≥ 0.75 g\u002F24 h at screening.\n* Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL\u002Fmin per 1.73 m\\^2 at screening.\n* Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.\n\nExclusion Criteria:\n\n* IgA nephropathy secondary to another condition\n* IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;\n* Chronic kidney disease (CKD) in addition to IgAN\n* Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；\n* Require any prohibited medications prior to randomizing;\n* Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening\n* History of organ transplantation, with exception of corneal transplants\n* Platelet\\\u003C 100×109\u002FL or hemoglobin value \\\u003C 90 g\u002FL) or Hematocrit value \\\u003C 27% (0.27 V\u002FV) at Screening\n* Elevations of transaminases (ALT and\u002For AST) \\>2 times upper limit of normal or total bilirubin and\u002For direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening\n* Potassium \\>5.5 mmol\u002FL at Screening","65 Years",{"count":514,"type":22},90,[107],"This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.",[518],"Immunoglobulin a Nephropathy",[520],"Immunoglobulin A Nephropathy","2024-10-08",{"date":523,"type":38},"2024-10-10",{"date":525,"type":22},"2024-11",{"date":527,"type":22},"2026-04-30",{"name":44,"class":45},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":536,"sex":17,"minAge":18,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":545,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":71},"100511683","phase-1-a-first-in-human-study-to-evaluate-safety-tolerability-pharmacology-of-hs-10390-in-healthy-subjects-100511683","NCT05942625","A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects","A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Studyto Evaluate the Safety, Tolerability and Pharmacokinetics of HS-10390 in Healthy Subjects","Inclusion Criteria:\n\n* Healthy male or female subjects between the ages of 18-45 years\n* Have no reproductive potential; or agree to use a highly effective method ofcontraception, and refrain from donating sperm or eggs during the study period and forat least 6 months after last dosing\n* Have signed the informed consent form approved by the IRB\n\nExclusion Criteria:\n\n* History or evidence of clinically significant cardiovascular, pulmonary, endocrine,gastrointestinal, psychiatric, neurologic, hematological or metabolic diseases, especiallythose conditions that interfere with absorption, metabolism and\u002For excretion of the studydrug, determined by the investigator\n* Have a clinically significant infection currently or within past 30 days, or have a history ofactive tuberculosis; or have positive screening test for infectious disease, includingtuberculosis, viral hepatitis, AIDS and syphilis\n* Have a history of or current allergic disease\n* Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol ordrugs of abuse\n* Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test resultfor nicotine\n* Clinically significant abnormal physical examination, vital signs, clinical laboratory values,ECGs or imaging tests\n* Pregnant or breastfeeding female subjects",true,"45 Years",{"count":539,"type":22},84,[25],"The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.",[543,544],"IgA Nephropathy","Focal Segmental Glomerulosclerosis",[546,547,548,549,550],"HS-10390","Safety","Tolerability","Pharmacokinetics","Pharmacodynamics","2024-10-07",{"date":553,"type":38},"2024-10-09",{"date":555,"type":38},"2023-05-23",{"date":557,"type":22},"2024-12-30",{"name":44,"class":45},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":575,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":586,"locationsCount":71},"100561807","phase-2-a-study-of-hs-20106-to-treat-anemia-due-to-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-100561807","NCT06594965","A Study of HS-20106 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes","Phase II Study on the Efficacy, Safety, and Pharmacokinetics of HS-20106 in Patients With IPSS-R Very Low-risk, Low-risk, or Moderate-risk Myelodysplastic Syndrome (MDS) Anemia","Inclusion Criteria:\n\n1. Diagnosis of MDS according to World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease（IPSS-R ≤ 3.5）.\n2. \\\u003C 5% blasts in bone marrow and \\\u003C 1% blasts in peripheral blood.\n3. Each cohort is defined as:\n\n   Cohort 1： In NTD participants, having received no red blood cell (RBC) transfusions within 16 weeks Hgb concentration between 60 and 100g\u002FL.\n\n   Cohort 2： In LTB participants, having received an average of \\\u003C 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks\u002F2) Hgb concentration between 60 and 100 g\u002FL.\n\n   In HTB participants, having received an average of ≥ 4 units of RBC transfused within 8 weeks (i.e., total blood transfused over 16 weeks\u002F2) Hgb concentration between 60 and 100 g\u002FL.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia.\n5. Females of child-bearing potential and sexually active males must agree to use effective methods of contraception.\n\nExclusion Criteria:\n\n1. Chromosome 5q deletion, del (5q).\n2. Anemia caused by other reasons, such as iron deficiency anemia, megaloblastic anemia, aplastic anemia, renal anemia or blood loss.\n3. Diagnosis of secondary MDS (i.e., MDS known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation for other diseases).\n4. Prior treatment with azacitidine, decitabine, lenalidomide, luspatercept, or sotatercept.\n5. Treatment within 4 weeks prior to C1D1 with:\n\n1\\) Erythropoiesis stimulating agent (ESA) OR 2) Granulocyte colony-stimulating factor (G-CSF) OR 3) Granulocyte-macrophage colony-stimulating factor (GM-CSF) 6. Iron chelation therapy if initiated within 8 weeks prior to C1D1. 7. Vitamin B12 therapy if initiated within 8 weeks prior to C1D1. 8. Treatment with another investigational drug or device or approved therapy for investigational use \\\u003C or = 4 weeks prior to C1D1, or if the half-life of the previous product is known, within 5 times the half-life prior to C1D1, whichever is longer.\n\n9\\. Peripheral blood white blood cell count \\>13.0 x 10\\*9\u002FL. 10. Neutrophil count \\\u003C 1.0 x 10\\*9\u002FL. 11. Platelet count \\> 450 x 10\\*9\u002FL or \\\u003C 30 x 10\\*9\u002FL. 12. Transferrin saturation \\\u003C 15%. 13. Ferritin \\\u003C 15 μg\u002FL. 14. Folate \\\u003C 4.5 nmol\u002FL (\\\u003C 2.0 ng\u002FmL). 15. Vitamin B12 \\\u003C 148 pmol\u002FL (\\\u003C 200 pg\u002FmL). 16. Estimated glomerular filtration rate (GFR) \\\u003C 40 mL\u002Fmin\u002F1.73 m2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\].\n\n17\\. Pregnant or lactating females",{"count":567,"type":22},176,[107],"The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HS-20106 on anemia in patients with very low, low or intermediate risk MDS.",[571,572,573,574],"Myelodysplastic Syndromes","Anemia","MDS","Bone Marrow Disease",[573,576,577,578,579],"HS-20106","KER-050","fusion protein","TGF-β","2024-09-14",{"date":582,"type":38},"2024-09-19",{"date":412,"type":22},{"date":585,"type":22},"2026-10-30",{"name":44,"class":45},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":601,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":610,"locationsCount":611},"100517180","phase-2-hs-20089-in-patients-with-ovarian-cancer-and-endometrial-cancer-100517180","NCT06014190","HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer","A Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer","Inclusion Criteria:\n\n1. Males or females aged 18 years or older (≥18 years).\n2. Patients diagnosed with recurrent or metastatic ovarian cancer, endometrial cancer or other solid tumors.\n3. Subjects have at least one target lesion as assessed per the RECIST 1.1. Patients with only brain and\u002For bone lesions as target lesions are ineligible.\n4. Tumor tissue from a newly obtained biopsy (FFPE tumor tissue blocks or slides are acceptable) is required. If the newly obtained biopsy is not feasible, newly obtained FFPE slides cut from archival tumor tissue blocks within 2 years prior to the first dose of study drug are acceptable.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.\n6. Have a life expectancy of at least 12 weeks.\n7. Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent until 6 months after the last dose; male subjects must agree to use barrier contraception (i.e. condoms) from signing the informed consent to 6 months after the last dose.\n8. Female subjects must have a negative pregnancy test within 7 days prior to the first dose (for subjects with tumor related abnormal elevation of human chorionic gonadotropin \\[HCG\\], an ultrasound of uterus and appendages should be performed within 7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for pregnancy.\n9. Subject must be voluntarily enrolled in this clinical trial, be able to understand the study procedures and to sign written informed consent.\n\nExclusion Criteria:\n\n1. Have received or is currently receiving the following treatment:\n\n   1. B7-H4-targeted therapies.\n   2. Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs (including endocrine therapy, molecular targeted therapy, biotherapy, etc.) within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.\n   3. Have received macromolecular antitumor drugs (including immunotherapy, such as monoclonal antibodies and bispecific antibodies) within 28 days prior to the first dose of study drug.\n   4. Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.\n   5. Major surgery (such as craniotomy, thoracotomy or laparotomy, etc.) within 4 weeks prior to the first dose of study treatment.\n   6. Use of strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp, or BCRP, or sensitive substrates of CYP3A4, CYP2D6, P-gp, or BCRP with narrow therapeutic window within 7 days prior to the first dose of study drug; or in need of continuing treatment with these drugs during the study.\n   7. Current use of drugs known to prolong the QT interval or potentially cause torsades de pointes; or need to continue these medications during the study.\n2. Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events (CTCAE version 5.0) due to prior anti-tumor therapy (except alopecia and residual neurotoxicity).\n3. Presence of pleural\u002Fabdominal effusion requiring clinical intervention.\n4. Known history of prior malignancy.\n5. Evidence of brain metastasis, unless meeting all of the following criteria:\n\n   1. Asymptomatic; medically stable for at least four weeks prior to the first dose;\n   2. No steroid treatment required for at least two weeks prior to the first dose;\n   3. No stereotactic radiation therapy, whole brain radiotherapy, and\u002For neurosurgical resection within 4 weeks prior to the first dose;\n   4. No history of intracranial or spinal hemorrhage;\n   5. Have at least one target lesion other than CNS lesion according to RECIST v1.1;\n6. Inadequate bone marrow reserve or hepatic\u002Frenal functions.\n7. Cardiological examination abnormality.\n8. Severe, uncontrolled or active cardiovascular disorders.\n9. Serious or poorly controlled diabetes.\n10. Serious or poorly controlled hypertension.\n11. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose of study treatment.\n12. Serious arteriovenous thromboembolic events within 3 months prior to the first dose of study treatment.\n13. Serious infections within 4 weeks prior to the first dose.\n14. Have received systemic glucocorticoid therapy for more than 30 days within 30 days prior to the first dose study treatment, or require chronic (≥ 30 days) use of systemic glucocorticoids during the study, or have other acquired, congenital immunodeficiency disorders, or a history of organ transplantation.\n15. Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus infection, etc.\n16. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more severe cirrhosis.\n17. Any moderate or severe lung diseases that may interfere with the detection and treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.\n18. History of severe neurological or psychiatric disorder.\n19. Pregnant or breast-feeding women or women who intend to become pregnant during the study.\n20. Attenuated live vaccination within 4 weeks prior to the first dose.\n21. Allergies or hypersensitivity reactions within 4 weeks prior to the first dose. History of severe allergies (e.g., anaphylactic shock), or severe infusion-related reactions. Allergy or hypersensitivity to any component of HS-20089.\n22. Subjects unlikely to comply with study procedures, restrictions and requirement as determined by the investigator.\n23. Subjects with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.",{"count":491,"type":22},[107],"HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.\n\nThis is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20089 as monotherapy in patients with recurrent or metastatic ovarian cancer and endometrial cancer.",[237,598,599,600],"Fallopian Tube Cancer","Primary Peritoneal Cancer","Endometrial Cancer",[240,602,603,237,600],"B7-H4","Antibody-drug Conjugate","2024-08-27",{"date":606,"type":38},"2024-08-29",{"date":608,"type":38},"2023-12-18",{"date":414,"type":22},{"name":44,"class":45},28,""]