[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zhejiang Doer Biologics Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,66],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100645349","phase-3-a-phase-3-trial-of-dr10624-versus-placebo-in-patients-with-severe-hypertriglyceridemia-100645349",false,"NCT07680829","A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe Hypertriglyceridemia","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of DR10624 Added to Standard Icosapent Ethyl Therapy in Adults With Severe Hypertriglyceridemia","Inclusion Criteria:\n\n1. Age ≥18 years, male or female; BMI 19.0-45.0 kg\u002Fm², body weight ≥50 kg at screening.\n2. Fasting triglyceride (TG) range 5.65-22.60 mmol\u002FL: single screening lab result meets range, plus average of two separate fasting TG tests (interval \\>1 week) within same range prior to randomization.\n3. Stable lipid-lowering medications per local guidelines if on statin, cholesterol absorption inhibitor or PCSK9 inhibitor (minimum stable dose duration as required by drug class).\n4. Females of childbearing potential agree effective contraception from ICF signing to 2 months post last dose; male participants agree contraception and no sperm donation for 3 months post last dose.\n5. Able to understand study procedures, maintain consistent lifestyle and follow all protocol-specified requirements, and provide written informed consent.\n\nExclusion Criteria:\n\n1. Confirmed hereditary lipid disorders (Fredrickson Type 1\u002F3, Apo C-II deficiency).\n2. Significant weight loss or planned weight reduction during study.\n3. Severe chronic liver, renal or advanced cardiac disease.\n4. Uncontrolled diabetes or hypertension with severe complications.\n5. Pancreatitis history or symptomatic gallbladder disease.\n6. Recent major cardiovascular, bone or thyroid disorders.\n7. Severe psychiatric illness or substance abuse history.\n8. Prior GLP-1\u002FGCGR\u002FFGF21 agonists or other investigational drugs within 3 months.\n9. Abnormal screening lab parameters related to liver, pancreas, kidney or viral infection.\n10. Pregnant, breastfeeding or hypersensitivity to study treatments.\n11. Investigator's judgment of unsuitability for participation.","ALL","18 Years",{"count":19,"type":20},378,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial for adults with severe hypertriglyceridemia whose lipid levels remain uncontrolled under standard Icosapent Ethyl background treatment plus lifestyle management. Eligible participants complete a screening run-in period, then randomize equally to three treatment groups: two active DR10624 subcutaneous injection groups and one placebo group. All subjects maintain fixed oral background lipid therapy throughout long-term double-blind treatment, followed by a short safety follow-up period. The primary objective is to evaluate the triglyceride-lowering effect of DR10624 versus placebo. Secondary assessments include other lipid indicators, liver fat content, overall safety, and anti-drug antibody status. Independent committees monitor interim data and adjudicate key clinical events to ensure participant safety.",[26],"Severe Hypertriglyceridemia","NOT_YET_RECRUITING","2026-07-01",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":20},"2026-08",{"date":35,"type":20},"2030-10",{"name":37,"class":38},"Zhejiang Doer Biologics Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":39},"100597306","phase-1-evaluation-of-the-preliminary-efficacy-and-safety-of-dr30206-in-combination-with-standard-therapy-in-patients-with-gastrointestinal-cancer-100597306","NCT07056777","Evaluation of the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Cancer","A Phase Ib\u002FIIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form.\n2. Patients must be ≥ 18 and ≤75 years of age.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Expected survival period of at least 3 months.\n5. Depending on the tumor type, subjects must meet the following respective requirements:\n\n   1. Colorectal cancer: i. Histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal cancer; ii. Subjects who have not previously received systemic chemotherapy(except for left-sided colorectal cancer with wild-type RAS\u002FBRAF); or subjects who have progressed after first-line chemotherapy with or without targeted or immunotherapy.\n   2. Other gastrointestinal tumors: i. Histologically or cytologically confirmed unresectable locally advanced or metastatic esophageal adenocarcinoma, gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma, with HER2-negative or low expression; ii. Subjects who have not previously received systemic chemotherapy; for patients who previously received adjuvant chemotherapy, neoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease with curative intent, if disease progression occurs more than 6 months after the completion of the last treatment, they are eligible for this study.\n6. According to RECIST v1.1, subjects must have at least one measurable lesion.\n7. Adequate bone marrow, liver, and renal function.\n8. Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 180 days after the end of the last medication.\n9. Able to understand and follow the scheduled visits, treatments, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Subjects with MSI-H or dMMR.\n2. A history of severe allergic reactions to other monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to any investigational drug or its components in this study.\n3. Use of high-dose corticosteroids (\\>10 mg\u002Fday prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 14 days prior to the first administration of the investigational drug.\n4. Received the following treatments or medications within 28 days before starting the study treatment: a. Inoculate live attenuated vaccines, or expect to receive such vaccines during the study treatment period or within 5 months after the last administration of the study treatment; b.Systemic treatment with anti-tumor drugs, or local anti-tumor therapy.\n5. Received local radiotherapy within 2 months prior to the first administration of investigational drug (palliative radiotherapy for bone metastasis completed more than 2 weeks before baseline tumor assessment is acceptable);\n6. Received non-specific immunomodulatory therapy (e.g., interleukins, interferons, thymosin, tumor necrosis factor, etc.) within 2 weeks prior to the first administration of investigational drug;\n7. Receipt of other investigational drugs or investigational medical devices within 28 days prior to the first administration of the investigational drug.\n8. Major surgery (defined as requiring general anesthesia and hospitalization for more than 24 hours) or severe traumatic injury within 28 days prior to the first administration of the investigational drug, or expected to require major surgery during the study period, except for minor procedures (e.g., tooth extraction, biopsy) deemed not to affect participation in the study by the investigator.\n9. Presence of severe chronic or active infections within 28 days prior to the first administration of the investigational drug, including but not limited to hospitalization for infection, sepsis, or severe pneumonia complications, or any active infection that the investigator considers may affect the participant's safety; or systemic antibiotic therapy within 2 weeks prior to the start of treatment (routine prophylactic anti-infective therapy is exempt).\n10. Persistent clinically significant toxicities (CTCAE 5.0 Grade 2 or higher, e.g., hyperpigmentation, alopecia, etc.), except for adverse reactions deemed to have no safety risk by the investigator, related to prior treatments (including systemic therapy, radiotherapy, or surgery).\n11. Presence of central nervous system (CNS) metastases and\u002For cancerous meningitis. Subjects who have received local treatment for brain metastases may be considered for participation in this study provided that imaging confirms no disease progression within 4 weeks prior to the first administration of the investigational drug, all neurological symptoms are stable, there is no evidence of new or enlarging CNS metastases, and radiotherapy, surgery, or corticosteroid therapy for CNS metastases has been discontinued for at least 28 days prior to the first administration of the investigational drug. However, cancerous meningitis, regardless of clinical stability, should be excluded.\n12. Hepatitis B virus infection (must meet both HBsAg positive and HBV-DNA \\> 500 IU\u002FmL), Hepatitis C virus infection (must meet both HCV-Ab positive and HCV-RNA positive), Human Immunodeficiency virus infection (HIV-Ab positive), active syphilis infection, active tuberculosis infection.\n13. There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing.\n14. Within 2 years prior to the first administration of the investigational drug, the subject has active autoimmune diseases requiring systemic treatment (e.g., use of glucocorticoids or immunosuppressive drugs). Replacement therapies (e.g., levothyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are permitted.\n15. Within 3 years prior to the first administration of the investigational drug, the subject has a history of other malignancies, except those cured by definitive treatment with expectation of cure, such as basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, or any in situ cancer treated by definitive resection (e.g., cervical intraepithelial neoplasia, ductal carcinoma in situ).\n16. The subjects have other severe or uncontrolled medical conditions, or the investigator deems the subject unsuitable for participation in this clinical trial or believes it would affect the subject's adherence to the study protocol, including but not limited to: a) History of or current concomitant severe respiratory diseases; b) Severe arterial or venous thromboembolic events within 6 months prior to the first investigational drug administration; c) Massive pleural effusion, ascites, or pericardial effusion with clinical symptoms or requiring symptomatic treatment within 28 days prior to the first investigational drug administration; d) Active or history of inflammatory bowel disease; e) History of severe peptic ulcer, gastrointestinal perforation, fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding, or esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first investigational drug administration; f) History of clinically significant bleeding symptoms within 1 month prior to the first study drug administration; g) Imaging at screening shows tumor encasement of major vessels or presence of significant necrosis or cavitation, and the investigator judges that enrollment would increase the risk of bleeding.\n17. The subject has a history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n18. The subject has a history of substance abuse or a mental disorder that may affect compliance with the study.\n19. Pregnant or breastfeeding women, where pregnancy is defined as the period from conception until the termination of pregnancy, and confirmed by a laboratory human chorionic gonadotropin (hCG) test within 7 days prior to the start of the study.\n20. Other conditions deemed unsuitable for participation in this study by the investigator.","75 Years",{"count":49,"type":20},186,[51,52],"PHASE1","PHASE2","This is a multicenter, open-label phase Ib\u002FIIa clinical study conducted in China, aimed at evaluating the safety tolerance, efficacy, pharmacokinetic (PK) characteristics, and immunogenicity of DR30206 in combination with standard treatment regimens for advanced or metastatic gastrointestinal tumors.",[55],"Gastrointestinal Cancer",[55],"RECRUITING","2026-06-27",{"date":60,"type":31},"2026-06-30",{"date":62,"type":31},"2025-03-25",{"date":64,"type":20},"2027-06-30",{"name":37,"class":38},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":39},"100526291","phase-1-evaluate-the-safety-tolerability-pharmacokinetics-of-dr30206-in-patients-with-advanced-or-metastatic-solid-tumors-100526291","NCT06132828","Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DR30206 in Patients With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign a written informed consent form\n2. Patients must be ≥ 18 and ≤75 years of age\n3. Part A: Subjects with advanced or metastatic malignant solid tumors confirmed by histology or cytology who have failed or are intolerant to standard therapy or have no effective standard therapy\n4. Part B: The NSCLC cohort is planned to enroll patients with histologically or cytologically confirmed NSCLC who have locally advanced or metastatic NSCLC and are not eligible for curative treatment; patients must have no histologically confirmed EGFR-sensitive mutations or ALK gene fusions; they must not have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; and they must provide tumor tissue samples (approximately 5 unstained slides) obtained at the time of or after diagnosis of locally advanced or metastatic disease and within 2 years, without radiotherapy, which must be confirmed by the central laboratory to have tumor PD-L1 TPS ≥1%. Other potential cohorts may include patients with histologically or cytologically confirmed advanced or metastatic specific tumor types who have failed standard therapy, are intolerant to standard therapy, or have no effective standard therapy. These include, but are not limited to, cervical cancer, hepatocellular carcinoma, TNBC (Triple Negative Breast Cancer), and other tumor types such as gastric cancer, ovarian cancer, colorectal cancer, and tumor types with efficacy signals (CR\u002FPR) identified during the dose escalation phase.\n5. Patients in part A must have at least one evaluable lesion, and in part B must have at least one measurable lesion according to RECIST v1.1\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1\n7. The expected survival period ≥3 months\n8. Adequate bone marrow, liver, and renal function\n9. Male or female subjects with fertility must agree to take effective contraceptive measures during the study period and within 6 months after the end of the last medication\n10. Be able to understand the procedures and methods of this study, and willing to strictly follow the clinical trial protocol to complete this study\n\nExclusion Criteria:\n\n1. Patients with a history of severe allergies to monoclonal antibodies (mAb) or bispecific antibodies, or known allergies to drug component of the study drug\n2. Patients with active malignant tumors within the past 2 years, except for the tumors participating in the study and locally cured tumors\n3. Severe chronic or active infections, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia, or any active infection that the investigator believes may affect the safety of the subject, within 4 weeks prior to the start of the study treatment; Systemic antibiotic treatment within 2 weeks before starting the study treatment\n4. Received the following treatments or medications within 4 weeks before starting the study treatment: a. Interventional clinical studies; b. Major surgery or severe traumatic injury, or expected to require major surgery during the study process; c. Inoculate live attenuated vaccines, or expect to receive such vaccines during the study treatment period or within 5 months after the last administration of the study treatment; Systemic treatment with anti-tumor drugs, or local anti-tumor therapy, or treatment with systemic immune stimulators (including but not limited to interferon or interleukin-2 (IL-2)\n5. Radical radiotherapy within 3 months before starting the study treatment\n6. Received systemic immunosuppressive medication treatment within 4 weeks prior to the start of the study, or is expected to require systemic immunosuppressive medication during the study treatment period\n7. Known active central nervous system (CNS) metastasis\n8. There have been clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to the first study drug dosing\n9. Active stage of autoimmune disease or immune deficiency or history of autoimmune disease or immune deficiency\n10. Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found on screening chest CT scans; Previously used hormone therapy for pneumonia\n11. Active or previously diagnosed inflammatory bowel disease (such as Crohn's disease, ulcerative colitis)\n12. During the screening period, there were a large or symptomatic moderate amount of pleural effusion, pericardial effusion, and abdominal effusion\n13. During the screening period, imaging showed that the tumor were surrounded by important blood vessels or had obvious necrosis or cavities, and the investigators determined that enrolling into the study would pose a risk of bleeding\n14. Previous or current complications such as gastrointestinal perforation surgery, wound healing, and bleeding events\n15. Current or recent use of aspirin (\\>325 mg\u002Fday) or treatment with clopidogrel, clopidogrel, and cilostazol (within 10 days prior to the first study drug dosing)\n16. Receiving full dose oral or parenteral anticoagulant or thrombolytic therapy, but still unstable for at least 2 weeks before the first study drug dosing\n17. Adverse reactions caused by previous treatment that have not recovered to CTCAE 5.0 level 1 or below (but pigmentation, hair loss, etc. can be included if the investigator deems that there is no safety risk)\n18. Known active infection\n19. The subject has previously received allogeneic stem cell or organ transplantation\n20. History of organ or hematopoietic stem cell transplantation that requires the use of immunosuppressants\n21. Pregnant or lactating women, defined as women in a state of pregnancy until termination of pregnancy, are determined by laboratory human chorionic gonadotropin (hCG) testing within 7 days prior to the start of the study\n22. Any other disease, medical condition or abnormality, metabolic dysfunction, alcohol or drug abuse or dependence, physical examination or lab testing results that potential impact on result interpretation or will increase the likelihood of complications for patients\n23. Participants who are not appropriate for this clinical trial at the discretion of the investigator",{"count":74,"type":20},216,[51],"This study is to characterize the safety,tolerability, pharmacokinetics(PK),and preliminary anti-tumor activity of DR30206, in subjects with advanced or metastatic solid tumors",[78],"Solid Tumor","2026-04-24",{"date":81,"type":31},"2026-04-27",{"date":83,"type":31},"2023-11-27",{"date":85,"type":20},"2027-09-30",{"name":37,"class":38},""]