[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioRay Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,65,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100631282","phase-2-clinical-trial-of-br2251-tablets-for-patients-with-primary-gout-and-hyperuricemia-100631282",false,"NCT07498647","Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia","A Multicenter, Randomized, Double-blind, Non-benzylisoxazole Propionic Acid (BIPA) Controlled Phase II Clinical Study Evaluating the Efficacy and Safety of BR2251 Tablets in Patients With Primary Gout and Hyperuricemia","BR2251-201","Inclusion Criteria:\n\n* Only those subjects who meet all the following inclusion criteria are eligible to participate in this study:\n* Voluntary participation in this trial and signing of the informed consent form, and those who can complete the trial according to the protocol;\n* Age between 18 and 75 years old (inclusive of the boundary value, based on the date of signing the informed consent form), regardless of gender;\n* Body Mass Index (BMI) ≥ 18 kg\u002Fm2 and ≤ 35 kg\u002Fm2;\n* Meeting the 2015 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) gout classification criteria, and serum uric acid (sUA) ≥ 420 μmol\u002FL during the screening period;\n* Women of reproductive age with negative pregnancy test during the screening period and before the first administration of the investigational drug (D1 \\[allowing a time window of -7 days\\]), and both female and male subjects of reproductive age must agree to voluntarily take effective contraceptive measures from the date of signing the informed consent form until 3 months after the last administration of the drug\n\nExclusion Criteria:\n\n* Those who are known or suspected to be allergic to the test drug or its components, or who have previously been intolerant to febuxostat or have contraindications.\n* Subjects with secondary gout accompanied by hyperuricemia caused by other diseases or medications.\n* Those who have had acute gout attacks within the previous 2 weeks.\n* Those who have been diagnosed with uric acid nephropathy in the past or have imaging or clinical manifestations of urinary system stones (such as hematuria, back pain) within the previous 2 weeks.\n* Those with other joint lesions that the investigator considers may confuse gouty arthritis, such as rheumatoid arthritis, pyogenic arthritis, traumatic arthritis, psoriatic arthritis, pseudogout, systemic lupus erythematosus, or joint lesions caused by chemotherapy, radiotherapy, chronic lead poisoning, acute obstructive nephropathy, etc.\n* Those with any disease or surgical history that the investigator judges may affect the PK characteristics of the drug, such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease, digestive organ resection, kidney resection, etc.\n* Those who have used any organic anion transporter 1 and 3 (OAT1\\&3) substrate drugs within the previous 2 weeks.\n* Those who have used any other uric acid-lowering drugs within the previous 2 weeks and have other concomitant medications that affect uric acid levels (including but not limited to losartan, calcium channel blockers, fenofibrate, atorvastatin calcium, alpha-glucosidase inhibitor, insulin sensitizers, DPP4 inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, metformin) using a stable dose.\n* Those who have used aspirin within the previous 2 weeks.\n* Those who have used any diuretic within the previous 2 weeks.\n* Those with diseases that require long-term use of drugs metabolized by xanthine oxidase, including but not limited to azathioprine, mercaptopurine, etc.\n* Any abnormal laboratory test results at screening: a. Abnormal liver function, defined as AST or ALT values \\> 2× the upper limit of normal (ULN), or TBIL \\> 1.5× ULN; b. WBC \\\u003C 3.0×109\u002FL, PLT \\\u003C 75×109\u002FL, or HB \\\u003C 90 g\u002FL; c. Scr \\> 1.5× ULN, or estimated eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 using the CKD-EPI formula; d. CK \\> 1.5× ULN.\n* Viral test results at screening: a. Those with positive hepatitis B surface antigen (HBsAg) and HBV-DNA \\> 1000 IU\u002FmL; b. Those with positive HCV antibody and positive HCV-RNA; d. Those with positive HIV serum reaction; e. Those with positive syphilis antibody and requiring treatment after consultation with the infectious disease department.\n* Other serious diseases that may limit the participation of the subjects in this trial, such as: uncontrolled diabetes (glycated hemoglobin \\> 8.4% as assessed by the investigator); severe heart failure (NYHA class II or above); acute coronary syndrome, acute cerebrovascular accident within the past 6 months; coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel-related surgeries within the past 6 months; severe arrhythmia within the past 6 months including frequent premature ventricular contractions, ventricular tachycardia, atrial fibrillation\u002Fatrial flutter, severe bradycardia; uncontrolled hypertension (greater than 160\u002F100 mmHg); severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm) etc.\n* Electrocardiogram at screening showing prolonged QTcF interval (Fridericia formula) (males \\> 450 ms, females \\> 470 ms).\n* Those who have had or currently have malignant tumors within the past 5 years (excluding skin squamous cell carcinoma, basal cell carcinoma, and cervical carcinoma in situ that have been successfully treated and without recurrence evidence).\n* Had any active infection at the time of screening, or had a severe infection within 4 weeks before randomization (requiring intravenous antimicrobial treatment or hospitalization), or had any infection that required oral antibiotic treatment within 2 weeks before randomization.\n* Have undergone organ\u002Ftissue transplantation or stem cell transplantation.\n* Within 12 weeks before randomization or within the planned period of any major surgical operation.\n* Judged by the investigator, had a history of prescription drug abuse or use of prohibited drugs within 6 months before randomization.\n* Judged by the investigator, had a daily alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of alcohol with 40% content of spirits or 150 mL of wine) within 1 month before randomization.\n* Pregnant or lactating women.\n* Have participated in other drug clinical studies, and the time since the last medication is less than 30 days before screening or 5 half-lives of the original test drug (whichever is longer), or plan to participate in another drug clinical trial during the study period.\n* Those considered by the investigator to have other symptoms or conditions that are not suitable for participating in this study.","ALL","18 Years","75 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in subjects with primary gout and hyperuricemia.\n\nThis study is a dose exploration study, including a screening period (up to 2 weeks), a double-blind treatment period (12 weeks), and a follow-up period (2 weeks). The screened subjects were stratified based on whether their serum uric acid (sUA) was less than 480 μmol\u002FL or greater than or equal to 480 μmol\u002FL. They were randomly assigned to 4 treatment groups in a 1:1:1:1 ratio: the test drug group 1 (low-dose group), the test drug group 2 (medium-dose group), the test drug group 3 (high-dose group), and the control group (non-befloxacin tablets 40 mg), with 40 subjects in each group. Each group will use titration dosing.",[28],"Gout and Hyperuricemia","NOT_YET_RECRUITING","2026-03-23",{"date":32,"type":33},"2026-03-27","ACTUAL",{"date":35,"type":22},"2026-04-01",{"date":37,"type":22},"2026-11-30",{"name":39,"class":40},"BioRay Pharmaceutical Co., Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100519016","phase-1-a-study-of-bry812-for-injection-alone-in-subjects-with-advanced-malignancies-100519016","NCT06038058","A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies","A Phase I Clinical Study of the Safety, Tolerability and Efficacy of BRY812 for Injection in Patients With Advanced Malignancies","Inclusion Criteria:\n\n* (1) Subjects who voluntarily sign the informed consent form, understand the nature, objectives, and procedure of the study and are able to complete the study according to the protocol;\n* (2) Male or female patients, ≥ 18 years of age (based on the date of signing the informed consent form);\n* (3) In Phase Ia: patients must have advanced solid tumors confirmed by histopathology and\u002For cytology, who have failed to respond to standard-of-care (disease progression after treatment) or who could not tolerate standard-of-care, or who could not obtain effective standard-of-care or for whom there was no effective standard-of-care available; (Note: the patient population and inclusion criteria in phase Ib will be determined according to the data of phase Ia);\n* (4) According to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), there is at least 1 measurable lesion;\n* (5) Eastern Cooperative Oncology Group (ECOG) Status 0 to 1;\n* (6) Adequate organ and bone marrow function (no treatment with cells, growth factors, or transfusions within 14 days prior to the first administration), as defined below:\n\n  1. Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL;\n  2. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (except for subjects with Gilbert syndrome, TBIL ≤ 2 × ULN in patients with liver cancer or liver metastases), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (in patients with liver cancer or liver metastases, ALT or AST ≤ 5 × ULN);\n  3. Renal function: creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CrCL) (based on Cockcroft-Gault equation) ≥ 60 mL\u002Fmin;\n* (7) Expected survival ≥ 12 weeks;\n* (8) Female subjects with fertility potential must test negative for serum human chorionic gonadotropin (HCG) before they are enrolled in the study. Female subjects with fertility potential or male subjects who have a female partner must agree to maintain no pregnancy plan and take effective contraceptive measures such as condoms from the signing of ICF to 6 months after the last dose of study drug (see Annex 1 for details); females are considered fertile from menarche to menopause (at least 12 months without menstruation) unless they are permanently infertile (through hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n* (1) Subjects who have previous severe hypersensitivity to BRY812 or known hypersensitivity to any component or excipient of the study drug;\n* (2) Subjects who have previously received drugs which target LIV-1;\n* (3) Subjects who have any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug;\n* (4) Subjects who have previous or current presence of two or more primary tumors (excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, and other tumors that have been stable for more than 5 years after treatment);\n* (5) Subjects who have symptoms of active central nervous system metastases, except those with brain parenchymal metastases assessed as stable by the investigator based on the following conditions:\n\n  1. No seizures within \\> 12 consecutive weeks with or without the treatment of antiepileptic drugs;\n  2. Glucocorticoids are not required;\n  3. Two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;\n  4. Asymptomatic inactive brain metastases are newly identified where two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;\n  5. The conditions remain stable and asymptomatic for more than 1 month after treatment;\n* (6) Subjects with serious cardiovascular and cerebrovascular diseases and lung diseases, including but not limited to:\n\n  1. Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA class III-IV), myocardial infarction, severe arrhythmias (such as sustained ventricular tachycardia and ventricular fibrillation), congenital long QT syndrome, torsade de pointes, and symptomatic pulmonary embolism within 6 months before enrollment;\n  2. Uncontrolled hypertension (at least 2 consecutive measurements of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);\n  3. Echocardiogram (ECHO) or multigated acquisition scan (MUGA) shows left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  4. During the screening period, the mean corrected (by Fridercia's formula) QT interval on three consecutive electrocardiograms is prolonged (\\> 450 ms in males and \\> 470 ms in females);\n  5. Subjects who have interstitial lung diseases, severe impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, and other lung diseases assessed by the investigator as clinically significant;\n* (7) Subjects who have active gastrointestinal bleeding or severe intestinal obstruction;\n* (8) Subjects who have undergone major surgery within 4 weeks prior to the first dose of study drug or are expected to be performed during the study;\n* (9) Subjects who have a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* (10) Subjects who have bleeding tendency or are receiving thrombolytic or anticoagulant therapy;\n* (11) Subjects who have used strong inhibitors or substrates of CYP3A4 and\u002For Pgp within 4 weeks before the first dosing or within 5 half-lives of the used drug (whichever is shorter), or who have received anti-tumor therapy or participated in other clinical studies and used other study drugs, including chemotherapy, targeted therapy, immunotherapy, biotherapy (tumor vaccines, cytokines, or growth factors for cancer control), etc.; or who have received prepared slices of Chinese crude drugs or Chinese patent medicines as anti-tumor treatment within 1 week before the first dose of study drug;\n* (12) Subjects who have received radiation therapy, including abdominal palliative stereotactic radiotherapy, within 4 weeks prior to the first dose of study drug (non-abdominal palliative stereotactic radiotherapy within 2 weeks prior to the first dose);\n* (13) Toxicity of previous antineoplastic therapy does not resolve to grade ≤ 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic abnormal laboratory findings considered by the investigator, such as elevated ALP, hyperuricemia, elevated blood glucose, etc.; except for toxicity with no safety risk determined by the investigator , such as alopecia, pigmentation, etc.);\n* (14) Subjects who have been vaccinated with a live vaccine within 4 weeks before the first dose, or who intend to be vaccinated with a live vaccine during the study;\n* (15) Subjects who have received more than 1 week of treatment with systemic corticosteroids (methylprednisolone \\> 10 mg\u002Fday or an equivalent dose of other similar drug) within 2 weeks prior to the first dose of study drug;\n* (16) Subjects who have used immunosuppressants within 2 weeks prior to the first dose or once had active autoimmune diseases or had a prior history of autoimmune diseases;\n* (17) Subjects who test positive for Hepatitis B surface antigen (HBsAg) with HBV DNA beyond the normal range; or subjects who test positive for hepatitis B core antibody with HBV DNA beyond the upper limit of normal, but do not agree to regular DNA testing during treatment and follow-up, or do not agree to receive antiviral therapy; subjects who test positive for hepatitis C virus (HCV) antibody and HCV RNA; subjects who are seropositive for human immunodeficiency virus (HIV); subjects who have syphilis and need to receive systemic treatment;\n* (18) Subjects who have any mental or cognitive disorders that may limit their understanding and execution of the informed consent form;\n* (19) Subjects who are pregnant or breastfeeding;\n* (20) Subjects who plan to donate sperm after signing the informed consent form and throughout the study period, or within 6 months after the last dose of the study drug;\n* (21) Subjects who are not eligible for enrollment or may not be able to complete the study due to other reasons by the investigator's assessment.",{"count":49,"type":22},164,[51],"PHASE1","This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BRY812 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies.\n\nPatients will receive treatment every 3 weeks until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.",[54],"Advanced Malignancies","RECRUITING","2025-12-23",{"date":58,"type":33},"2025-12-30",{"date":60,"type":33},"2023-10-10",{"date":62,"type":22},"2028-12",{"name":39,"class":40},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":4},"100616894","phase-2-phase-iia-study-of-bry812-monotherapy-in-advanced-gynecological-malignancies-100616894","NCT07311538","Phase IIa Study of BRY812 Monotherapy in Advanced Gynecological Malignancies","A Phase IIa Study to Investigate the Efficacy and Safety of BRY812 for Injection in Patients With LIV-1 Positive Advanced Gynecologic Malignancies","Inclusion Criteria:\n\n* (1) Subjects who voluntarily sign the informed consent form, understand the nature, objectives, and procedure of the study and are able to complete the study according to the protocol;\n* (2) Female patients, ≥ 18 years of age (based on the date of signing the informed consent form);\n* (3) LIV-1 positive, as assessed by a central laboratory\n* (4) Patients with histologically or cytologically confirmed locally advanced or metastatic gynecological malignancies are enrolled into two cohorts:\n\nCohort 1 (Ovarian Cancer):\n\nDiagnosis of high-grade serous epithelial ovarian cancer (EOC). Must have received 1 to 3 prior lines of systemic anticancer therapy.\n\nCohort 2 (Endometrial Cancer and Ovarian Clear Cell Carcinoma):\n\nFor Endometrial Cancer: Diagnosis of recurrent or metastatic advanced endometrial carcinoma (all histologies except sarcoma). Patients must have received up to 3 prior lines of systemic therapy, platinum-based chemotherapy and anti-PD-1\u002FPD-L1 therapy .\n\nFor Ovarian Clear Cell Carcinoma: Pathologically confirmed ovarian clear cell carcinoma. The definitions for prior therapy lines (1-3 lines) are the same as for Cohort 1.\n\n* (5) According to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors), there is at least 1 measurable lesion;\n* (6) Radiographic disease progression must have occurred during or after the most recent anti-tumor therapy.\n* (7) Eastern Cooperative Oncology Group (ECOG) Status 0 to 1;\n* (8) Adequate organ and bone marrow function (no treatment with cells, growth factors, or transfusions within 14 days prior to the first administration), as defined below:\n\n  1. Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 100 × 109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL;\n  2. Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN;\n  3. Renal function: creatinine clearance (CrCL) (based on Cockcroft-Gault equation) ≥ 60 mL\u002Fmin;\n* (9) Expected survival ≥ 12 weeks;\n* (10) Female subjects with fertility potential must test negative for serum human chorionic gonadotropin (HCG) before they are enrolled in the study. Female subjects with fertility potential or male subjects who have a female partner must agree to maintain no pregnancy plan and take effective contraceptive measures such as condoms from the signing of ICF to 6 months after the last dose of study drug (see Annex 1 for details); females are considered fertile from menarche to menopause (at least 12 months without menstruation) unless they are permanently infertile (through hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).\n\nExclusion Criteria:\n\n* (1) Subjects who have previous severe hypersensitivity to BRY812 or known hypersensitivity to any component or excipient of the study drug;\n* (2) Subjects who have previously received drugs which target LIV-1, or MMAE-containing drugs, including but not limited to antibody-drug conjugates (ADCs) that utilize MMAE as the cytotoxic payload;\n* (3) Subjects who have any active infection requiring systemic therapy by intravenous infusion within 2 weeks prior to the first dose of study drug;\n* (4) Subjects who have previous or current presence of two or more primary tumors (excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin, and other tumors that have been stable for more than 5 years after treatment);\n* (5) Subjects who have symptoms of active central nervous system metastases, except those with brain parenchymal metastases assessed as stable by the investigator based on the following conditions:\n\n  1. No seizures within \\> 12 consecutive weeks with or without the treatment of antiepileptic drugs;\n  2. Glucocorticoids are not required within the 2 weeks prior to the first dose;\n  3. Two consecutive MRI scans (at least 4 weeks apart) show a stable state on imaging;\n  4. The conditions remain stable and asymptomatic for more than 1 month after treatment;\n* (6) Subjects with serious cardiovascular and cerebrovascular diseases and lung diseases, including but not limited to:\n\n  1. Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA class III-IV), myocardial infarction, severe arrhythmias (such as sustained ventricular tachycardia and ventricular fibrillation), congenital long QT syndrome, torsade de pointes, and symptomatic pulmonary embolism within 6 months before enrollment;\n  2. Uncontrolled hypertension (at least 2 consecutive measurements of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg);\n  3. Echocardiogram (ECHO) or multigated acquisition scan (MUGA) shows left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  4. During the screening period, the mean corrected (by Fridercia's formula) QT interval on three consecutive electrocardiograms is prolonged (\\> 470 ms);\n  5. Subjects who have interstitial lung diseases, severe impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, and other lung diseases assessed by the investigator as clinically significant;\n* (7) Subjects who have active gastrointestinal bleeding or severe intestinal obstruction;\n* (8) Subjects who have undergone major surgery within 4 weeks prior to the first dose of study drug or are expected to be performed during the study;\n* (9) Subjects who have a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* (10) Thromboembolic events diagnosed within 6 months prior to the first dose that require therapeutic anticoagulation (except for stable, long-term maintenance anticoagulation for events diagnosed \\>6 months ago), or known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders). Prophylactic anticoagulation at low doses (e.g., low molecular weight heparin, direct thrombin inhibitors, or factor Xa inhibitors) is permitted;\n* (11) Subjects who have used strong inhibitors or substrates of CYP3A4 and\u002For P-gp within 4 weeks before the first dosing or within 5 half-lives of the used drug (whichever is shorter), or who have received anti-tumor therapy or participated in other clinical studies and used other study drugs, including chemotherapy, targeted therapy, immunotherapy, biotherapy (tumor vaccines, cytokines, or growth factors for cancer control), etc.; or who have received prepared slices of Chinese crude drugs or Chinese patent medicines as anti-tumor treatment within 1 week before the first dose of study drug;\n* (12) Subjects who have received radiotherapy within 4 weeks prior to the first dose of the study drug, with specific timelines as follows: within 4 weeks for palliative stereotactic radiotherapy to the abdomen or for whole-brain radiotherapy (WBRT) \u002F wide-field radiotherapy; within 2 weeks for palliative stereotactic radiotherapy to non-abdominal sites or limited-field radiotherapy for symptom relief. Additionally, patients with a history of radiotherapy involving \\>30% of the bone marrow are excluded.\n* (13) Toxicity of previous antineoplastic therapy does not resolve to grade ≤ 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic abnormal laboratory findings considered by the investigator, such as elevated ALP, hyperuricemia, elevated blood glucose, etc.; except for toxicity with no safety risk determined by the investigator, such as alopecia, pigmentation, etc.);\n* (14)Subjects with active or chronic corneal disorders, a history of corneal transplantation, or active ocular diseases requiring ongoing treatment\u002Fmonitoring.\n* (15) Subjects who have been vaccinated with a live vaccine within 4 weeks before the first dose, or who intend to be vaccinated with a live vaccine during the study;\n* (16) Subjects who have received more than 1 week of treatment with systemic corticosteroids (methylprednisolone \\> 10 mg\u002Fday or an equivalent dose of other similar drug) within 2 weeks prior to the first dose of study drug;\n* (17) Subjects who have used immunosuppressants within 2 weeks prior to the first dose or once had active autoimmune diseases or had a prior history of autoimmune diseases;\n* (18) Subjects who test positive for Hepatitis B surface antigen (HBsAg) with HBV DNA beyond the normal range; or subjects who test positive for hepatitis B core antibody with HBV DNA beyond the upper limit of normal, but do not agree to regular DNA testing during treatment and follow-up, or do not agree to receive antiviral therapy; subjects who test positive for hepatitis C virus (HCV) antibody and HCV RNA; subjects who are seropositive for human immunodeficiency virus (HIV); subjects who have syphilis and need to receive systemic treatment;\n* (19) Subjects who have any mental or cognitive disorders that may limit their understanding and execution of the informed consent form;\n* (20) Subjects who are pregnant or breastfeeding;\n* (21) Subjects who are not eligible for enrollment or may not be able to complete the study due to other reasons by the investigator's assessment.","FEMALE",{"count":74,"type":22},56,[25],"This study is a single-arm, open-label, multicenter Phase IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of BRY812 for Injection in patients with LIV-1-positive advanced gynecological malignancies. The study comprises two cohorts. For Cohort 1 (ovarian cancer), a Simon's two-stage design is adopted. In the first stage, 13 evaluable subjects will be enrolled. If fewer than 3 subjects achieve an objective response among these 13, enrollment in this cohort will be terminated. Otherwise, the cohort will proceed to the second stage, and additional 23 evaluable subjects will be enrolled, bringing the total to 36. If at least 10 out of the 36 evaluable subjects achieve an objective response, the cohort will be considered worthy of further investigation. Cohort 2 (endometrial cancer and ovarian clear cell carcinoma) plans to enroll approximately 20 subjects in a single stage.",[78],"Advanced Gynecological Malignancies","2025-12-22",{"date":81,"type":33},"2025-12-31",{"date":83,"type":22},"2025-12",{"date":85,"type":22},"2028-11",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":64},"100588174","phase-1-a-study-of-br111-in-patients-with-advanced-malignancies-100588174","NCT06937957","A Study of BR111 in Patients With Advanced Malignancies","A Phase I Study to Investigate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of BR111 for Injection in Patients With Advanced Malignancies","Inclusion Criteria:\n\n1. Willingness to provide written informed consent for the study;\n2. Age ≥ 18 years, male or female; Patients with solid tumors: Patients with histopathologically confirmed advanced solid tumors who are not amenable to surgical resection who have failed standard therapy (i.e., existing therapies with known clinical benefit) (disease progression during or after treatment) or who cannot tolerate standard therapy and are unable to obtain or refuse or have no standard therapy.\n\n   Patients with lymphoma: Patients with histopathologically confirmed relapsed\u002Frefractory B-cell lymphoma who meet the 2016 WHO classification criteria and are indicated for treatment and currently have no other standard treatment as judged by the investigator.\n3. All patients are required to provide tumor samples for biomarker analysis at screening.\n4. ECOG score 0 to 1 .\n5. Life expectancy ≥ 3 months.\n6. Phase Ia dose Escalation: Patients with solid tumors or lymphoma have at least one evaluable lesion at baseline (ie, no measurable lesions) according to RECIST v1.1 or Lugano 2014 criteria; Phase Ia Safety Expansion and Phase Ib: Patients with at least 1 measurable lesion at baseline according to RECISTv1.1 and Lugano 2014 criteria. Lesions previously treated with radiotherapy or intervention should not be considered target lesions unless there is unequivocal progression.\n7. Adequate organ and bone marrow function ；\n8. Female patients of childbearing potential (defined as those who are not surgically sterile with hysterectomy and\u002For bilateral oophorectomy and are not postmenopausal, defined as having amenorrhea ≥ 12 months) must have a negative pregnancy test at entry into this study and must be non-lactating; female patients of childbearing potential or male patients with sexual partners of childbearing potential are willing to use appropriate effective contraceptive measures such as abstinence and double-barrier methods (e.g., condom plus diaphragm), oral contraceptives, and placement of an intrauterine device during the study and for 6 months after the last investigational product.\n9. Able to understand trial requirements and willing and able to comply with trial and follow-up procedures.\n\nExclusion Criteria:\n\nPatients will not be eligible to participate in the study if they meet any of the following exclusion criteria:\n\n1. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE 5.0, Grade ≤1 or baseline（except for alopecia, pigmentation, or other toxicities judged by the investigator to have no safety risk）；\n2. Known history of allergy or delayed allergic reactions to BR111 for Injection and its components and considered severe by the investigator;\n3. Prior use of eribulin, or the treatments or clinical trials based on eribulin , or prior use of drugs or clinical trials targeting ROR1;\n4. Primary central nervous system malignancy or invasion of the central nervous system (Patients with CNS invasion may be considered for enrollment if they are untreated but asymptomatic, or with CNS metastases that have been radiologically documented to be progression-free for at least 4 weeks and require no treatment for at least 4 weeks). ;\n5. Patients with bacterial, viral, fungal, mycobacterial, parasitic or other infections within 14 days before the first dose and requiring intravenous infusion therapy (except for neoplastic fever);\n6. Patients with a history of (non-infectious) interstitial lung disease\u002Fpneumonia requiring steroid therapy, or current interstitial lung disease\u002Fnon-infectious pneumonia, or suspected interstitial lung disease\u002Fnon-infectious pneumonia that cannot be excluded by imaging at screening; radiation pneumonitis patients without clinical symptoms after 3 months of radiotherapy can be enrolled;\n7. Advanced malignant tumor complications resulting in quiescent dyspnea or current need for continuous oxygen therapy;\n8. Patients with moderate to severe lung diseases that have clinically significant impact on lung function, including but not limited to pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, or previous pneumonectomy within 3 months before enrollment;\n9. Peripheral neuropathy of Grade ≥ 2 (refer to NCI CTCAE 5.0) ;\n10. Accompanied by severe cardiovascular and cerebrovascular diseases or other serious organic diseases, including but not limited to:\n\n    * Stroke, intracranial hemorrhage, unstable angina pectoris, congestive heart failure (NYHA Class III-IV), myocardial infarction, severe arrhythmia (such as sustained ventricular tachycardia, ventricular fibrillation), congenital long QT syndrome, torsades de pointes, etc. within 6 months prior to the first dose;\n    * Left ventricular ejection fraction LVEF \\\u003C 50% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan;\n    * Mean corrected QT interval prolongation \\> 470 ms in 3 consecutive ECGs during the screening period, and QT interval correction (QTcF) is performed using the F ridercia formula;\n    * Grade ≥3 hypertension that cannot be stably controlled (refer to NCI CTCAE 5.0);\n    * Known inherited or acquired bleeding disorders or significant coagulation abnormalities (e.g., disseminated intravascular coagulation (DIC), autoimmune anemia, etc.)\n11. Complete intestinal obstruction before the first dose, or pericardial effusion with clinical symptoms requiring drainage, or pleural and peritoneal effusion, or skin lesions that are difficult to heal, recurrent episodes of any cause, and\u002For nonhealing ulcers (except for cancerous ulceration);\n12. Patients with previous or suspected serious skin conditions prior to first dose, including but not limited to bullous or exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), and drug reaction with eosinophilia and systemic symptoms (DRESS);\n13. Patients with immunodeficiency or active autoimmune diseases (except those with immune-related adverse reactions caused by previous application of immune checkpoint inhibitors that are relieved or stabilized at grade 1 after treatment) or requiring systemic steroid therapy. For patients with solid tumors: systemic corticosteroids at doses \\> 10 mg\u002Fday prednisone or equivalent hormone for more than 1 week within 14 days prior to first dose; for patients with lymphoma: systemic corticosteroids at doses \\> 20 mg\u002Fday prednisone or equivalent hormone for more than 1 week within 14 days prior to first dose ;\n14. Any other malignancy within 3 years (except basal cell carcinoma of the skin that has been radically treated and has not recurred, squamous cell carcinoma of the skin, superficial bladder cancer, localized prostate cancer, cervical cancer in situ, ductal carcinoma in situ of the breast, and malignancies that have been cured (CR) within 2 years prior to the first dose and judged by the investigator to be in stable disease status with minimal risk of recurrence);\n15. HIV virus test positive; syphilis infection requiring systemic treatment; HCVAb positive with HCV RNA titer above the upper limit of normal detected at the same time; Patients with solid tumors: HBsAg positive with HBV DNA ≥ 500 IU\u002FmL at the same time; Patients with lymphoma: HBsAg positive or HBcAb positive, simultaneous HBV DNA ≥ 500 IU\u002FmL;\n16. Participated in other clinical trial treatment within 4 weeks prior to the first dose (i.e., within 4 weeks from the last clinical trial drug\u002Fdevice treatment); Note: If the human half-life of the investigational product is clearly known, there should be an interval of at least 4 weeks or 5 half-lives (whichever is shorter) between the patient's previous clinical trial medication and the first dose of BR111;\n17. Major surgery or serious trauma within 4 weeks prior to the first dose that has not fully recovered or surgery is expected during the trial ;\n18. Received anti-tumor therapy such as radiotherapy and targeted therapy within 4 weeks prior to the first dose of study drug, as well as the following:\n\n    Received nitrosoureas (e.g., carmustine, romosustine, etc.) or mitomycin C within 6 weeks before the first dose; palliative radiotherapy for bone metastases or local radiotherapy for pain relief within 2 weeks before the first dose; chemotherapy, small molecule targeted drugs, endocrine therapy, or fluorouracil within 2 weeks before the first dose, but patients with prostate cancer are allowed to continue luteinizing hormone-releasing hormone (LHRH) agonist\u002Fantagonist therapy during the study; and traditional Chinese medicines or modern traditional Chinese medicine preparations with anti-tumor indications within 2 weeks before the first dose;\n19. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation or autologous hematopoietic stem cell transplantation less than 3 months before the first dose or CAR-T cell therapy less than 3 months before the first dose;\n20. Any mental or cognitive impairment that may limit their understanding and execution of the informed consent form;\n21. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with the results or other serious or uncontrollable disease conditions that, in the opinion of the investigator, may pose a risk to the patient by participating in this study.",{"count":95,"type":22},166,[51],"This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR111-101 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR111-101 for injection in patients with advanced malignancies.",[54],"2025-11-18",{"date":101,"type":33},"2025-11-21",{"date":103,"type":33},"2025-04-24",{"date":105,"type":22},"2027-12-31",{"name":39,"class":40},""]