[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eddingpharm (Zhuhai) Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100649788","phase-1-gb268-monotherapy-or-combination-therapy-for-locally-advancedmetastatic-breast-cancer-phase-ib-100649788",false,"NCT07738341","GB268 Monotherapy or Combination Therapy for Locally Advanced\u002FMetastatic Breast Cancer (Phase Ib\u002FⅡ)","A Open-label, Multicenter Phase Ib\u002FⅡ Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GB268 for Injection as Monotherapy or in Combination Regimens in Patients With Locally Advanced Unresectable or Metastatic Breast Cancer","Cohort-Specific Requirements:\n\nCohort A: Histologically confirmed locally advanced unresectable or metastatic Triple-Negative Breast Cancer \\[TNBC\\]; no prior systemic therapy for advanced disease; prior adjuvant\u002Fneoadjuvant taxane allowed if recurrence ≥6 months after last taxane dose; no prior Trop-2 Antibody-Drug Conjugate \\[ADC\\].\n\nCohort B: Histologically confirmed locally advanced unresectable or metastatic TNBC; no prior systemic therapy for advanced disease; prior adjuvant\u002Fneoadjuvant taxane allowed if recurrence ≥12 months after last taxane dose.\n\nCohort E: Histologically confirmed locally advanced unresectable or metastatic HR+\u002FHER2- breast cancer; disease progression after ≥1 line of endocrine therapy (aromatase inhibitor and\u002For fulvestrant) and CDK4\u002F6i in advanced setting; received ≥1 line of systemic chemotherapy in advanced setting; no prior Trop-2 ADC.\n\nCohort F: Histologically confirmed locally advanced unresectable or metastatic HR+\u002FHER2- breast cancer; disease progression after ≥1 line of endocrine therapy and CDK4\u002F6i with primary or secondary endocrine resistance; prior adjuvant\u002Fneoadjuvant taxane allowed if recurrence ≥12 months after last taxane dose.\n\nCohort G: Histologically confirmed locally advanced unresectable or metastatic HR+\u002FHER2- breast cancer; prior CDK4\u002F6i and endocrine therapy in any setting; received a TROP2 or HER2 ADC in advanced setting.\n\nInclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Histologically confirmed locally advanced unresectable or metastatic breast cancer (Triple-Negative Breast Cancer \\[TNBC\\] or Hormone Receptor-Positive\u002FHuman Epidermal Growth Factor Receptor 2-Negative \\[HR+\u002FHER2-\\]).\n3. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 \\[RECIST v1.1\\].\n4. No prior treatment with any immune checkpoint inhibitor (e.g., anti-Programmed Death-1 \\[PD-1\\], anti-Programmed Death-Ligand 1 \\[PD-L1\\], anti-Cytotoxic T-Lymphocyte-Associated Protein 4 \\[CTLA-4\\]) or Programmed Death-1\u002FVascular Endothelial Growth Factor \\[PD-1\u002FVEGF\\] bispecific antibody, except for adjuvant therapy if relapse occurred ≥12 months after discontinuation.\n5. Assessed by the investigator as suitable for the assigned combination therapy.\n6. Eastern Cooperative Oncology Group \\[ECOG\\] performance status 0 or 1.\n7. Life expectancy ≥ 3 months.\n8. Adequate organ function (within 14 days before first dose, without transfusion or Granulocyte Colony-Stimulating Factor \\[G-CSF\\] support): Hemoglobin ≥ 9 g\u002FdL, Absolute Neutrophil Count \\[ANC\\] ≥ 1.5×10\\^9\u002FL, Platelets ≥ 100×10\\^9\u002FL; Aspartate Aminotransferase \\[AST\\] and Alanine Aminotransferase \\[ALT\\] ≤ 3×Upper Limit of Normal \\[ULN\\] (≤5×ULN if liver metastases); Alkaline Phosphatase \\[ALP\\] ≤ 2.5×ULN (≤5×ULN if bone or liver metastases); Total Bilirubin ≤ 1.5×ULN (≤3×ULN for Gilbert's Syndrome); Serum Creatinine ≤ 1.5×ULN or Creatinine Clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula); Urine protein dipstick ≤ 1+ (if ≥2+, 24-hour urine protein quantification \\\u003C 1 g); Coagulation function: International Normalized Ratio \\[INR\\] or activated Partial Thromboplastin Time \\[aPTT\\] ≤ 1.5×ULN (for patients not on anticoagulation therapy).\n9. Provide a Formalin-Fixed Paraffin-Embedded \\[FFPE\\] tumor tissue sample for biomarker testing.\n10. Effective contraception for fertile participants.\n\nExclusion Criteria:\n\n1. Prior anti-cancer therapy within specified washout periods.\n2. Systemic immunosuppressive therapy within 2 weeks before first dose.\n3. Major surgery or significant traumatic injury within 4 weeks before first dose.\n4. Unresolved toxicity from prior therapy \\> Grade 1 (except alopecia or Grade ≤2 hypothyroidism stable on hormone replacement).\n5. Prior immune-related adverse events \\[irAEs\\] ≥ Grade 3 leading to treatment discontinuation.\n6. Active Central Nervous System \\[CNS\\] metastases (except stable asymptomatic lesions).\n7. History of other malignancies within 3 years (except cured non-melanoma skin cancer or carcinoma in situ).\n8. Uncontrolled pleural effusion or ascites requiring repeated drainage.\n9. Clinically significant cardiovascular disease (e.g., myocardial infarction, unstable angina, stroke within 6 months; QTcF prolongation; New York Heart Association \\[NYHA\\] Class II-IV heart failure; pericarditis\u002Fmyocarditis).\n10. History of Interstitial Lung Disease \\[ILD\\] or non-infectious pneumonitis requiring steroids.\n11. Active or history of autoimmune disease requiring systemic treatment in the past 2 years.\n12. History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea).\n13. History of hypertensive crisis or hypertensive encephalopathy.\n14. Severe coagulation disorders or significant bleeding risk (e.g., severe vascular disease, hemoptysis, intracranial\u002Fspinal hemorrhage, tumor invading major vessels).\n15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.\n16. Active infection requiring systemic anti-infective therapy within 2 weeks; severe infection within 4 weeks.\n17. Uncontrolled intercurrent illness (e.g., poorly controlled hypertension or Type 2 diabetes mellitus).\n18. Known active tuberculosis \\[TB\\].\n19. Positive for Hepatitis B Virus \\[HBV\\] surface antigen \\[HBsAg\\] or core antibody \\[HBcAb\\] with HBV-Deoxyribonucleic Acid \\[DNA\\] \\> 500 IU\u002FmL; or positive Hepatitis C Virus \\[HCV\\] antibody with HCV-Ribonucleic Acid \\[RNA\\] above the lower limit of quantification.\n20. Known primary immunodeficiency or positive Human Immunodeficiency Virus \\[HIV\\] antibody.\n21. History of solid organ or hematopoietic stem cell transplantation (except corneal transplant).\n22. Pregnant or breastfeeding women.\n23. Known hypersensitivity to GB268 or its excipients; history of severe hypersensitivity to other monoclonal antibodies.\n24. Any other condition that would make the participant unsuitable for the study.\n25. History of severe hypersensitivity to other drugs in the combination regimen.","ALL","18 Years",{"count":19,"type":20},270,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase Ib\u002FII, open-label, multi-cohort, multi-center study to evaluate the safety, tolerability, and preliminary anti-tumor activity of GB268, a biological product, as monotherapy or in combination with other therapies in patients with locally advanced unresectable or metastatic breast cancer.",[27],"Breast Cancer (Locally Advanced or Metastatic)",[29,30,31,32,33],"GB268","Immunotherapy","PD-1","CTLA-4","VEGF","NOT_YET_RECRUITING","2026-07-27",{"date":37,"type":38},"2026-07-31","ACTUAL",{"date":40,"type":20},"2026-08-01",{"date":42,"type":20},"2030-08-01",{"name":44,"class":45},"Eddingpharm (Zhuhai) Co., Ltd.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100630556","phase-2-a-dose-exploration-study-of-edp167-in-hofh-100630556","NCT07489209","A Dose-exploration Study of EDP167 in HoFH","A Multicenter, Dose-exploration, Open-label Phase II Study to Evaluate the Efficacy and Safety of EDP167 in Adult Patients With Homozygous Familial Hypercholesterolaemia","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female, and weight ≥40 kg.\n2. Genetic diagnosis or clinical diagnosis of HoFH.\n3. Fasting serum LDL-C ≥2.6 mmol\u002FL.\n4. Follow a daily low-fat diet during the study.\n5. Receiving stable and tolerable lipid-lowering treatment or other drugs for chronic diseases treatments for certain periods before the study, and maintain the stable treatments throughout the study.\n6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative pregnancy test prior to receiving EDP167 at baseline.\n7. Agree to use contraceptive measures that comply with regulations and the protocol requirements during the study, and until 6 months after the last dose.\n8. Understand the study procedures, voluntarily participate, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Allergic to the drug in this study, its components or similar drugs.\n2. Used any antisense oligonucleotide (ASO) or small interfering nucleic acid (siRNA) drugs within 12 months prior to randomization.\n3. Received treatment targeting ANGPTL3 or Apolipoprotein C3 (ApoC3), or have participated in other clinical trials within 6 months or 5 half-life (whichever longer) prior to screening.\n4. Received health supplements or other medications that have been used for lipid-lowering purposes within 4 weeks prior to screening.\n5. Received Lipoprotein apheresis within 8 weeks prior to screening.\n6. A weight change of \\>10% within 4 weeks prior to randomization, or planning to undergo weight-loss surgery or weight intervention treatment during the study period.\n7. Starting a new diet plan or having significant differences from the previous diet within 4 weeks prior to randomization.\n8. Presence of diseases that would affect lipid or lipoprotein levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, hypothyroidism or hyperthyroidism, etc., which are poorly controlled, and in the opinion of the Investigator will interfere with the accurate assessment of the study results.\n9. Had New York Heart Association (NYHA) grade III-IV heart failure within 12 months prior to randomization, or acute coronary syndrome or stroke within 6 months prior to randomization.\n10. Performed coronary intervention within 6 months prior to randomization, or plan to perform coronary intervention during the study.\n11. Have a history of major surgery within 3 months prior to screening, or plan to undergo major surgery during the study.\n12. History of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years prior to the first dose of EDP167; excluding adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, or incidental histological findings of prostate cancer (TNM stage T1a or T1b).\n13. Clinical evidence of active infections or other major or poorly controlled serious diseases, any other conditions that in the opinion of the Investigator may interfere with the study results or put the subjects at excessive risk.\n14. Have a history of current existence of alcohol or drug abuse per evaluation of the investigator.\n15. Uncontrolled hypertension at screening (blood pressure \\>160\u002F100 mmHg).\n16. Subjects with any of the following laboratory abnormalities at screening: a) fasting serum TG≥5.6 mmol\u002FL; b) Glycosylated hemoglobin A1C (HbA1c)\\>8.5%; c) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyl transpeptidase (GGT)\\>1.5×ULN (Upper Limit Of Normal), total bilirubin (TBIL)\\>2×ULN; d) prothrombin time (PT) or activated partial thromboplastin time (APTT) or International Normalized Ratio (INR) clinically significant abnormal; e) Hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCVAb) or human immunodeficiency virus (HIV) positive; f) estimated glomerular filtration rate (eGFR)\\\u003C30 mL\u002Fmin\u002F1.73m2.\n17. Donated or lost blood ≥400 mL within 3 months prior to screening.\n18. Women who are pregnant, breastfeeding or planning for pregnancy.\n19. Other conditions that the Investigator would consider the subject is not suitable to participate in this study.",{"count":54,"type":20},20,[24],"EDP167 is a double-stranded small interfering RNA (siRNA) drug targeting angiopoietin-like 3 protein (ANGPTL3), which may bring benefits for patients with dyslipidemia conditions. This is a dose exploration study in Homozygous Familial Hypercholesterolaemia (HoFH) patients to evaluate the efficacy and safety and pharmacokinetics (PK)\u002Fpharmacodynamics (PD) profiles of multiple EDP167 injections.",[58],"Homozygous Familial Hypercholesterolemia (HoFH)",[60,61,62,63],"Dyslipidemia","ANGPTL3","siRNA","HoFH","RECRUITING","2026-05-19",{"date":67,"type":38},"2026-05-20",{"date":69,"type":38},"2026-02-06",{"date":71,"type":20},"2027-03-31",{"name":44,"class":45},1,""]