[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-gynecological-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-gynecological-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100627460","phase-2-a-study-of-skb518-as-monotherapy-or-combination-therapy-in-patients-with-advanced-gynecological-malignant-tumors-100627460",false,"NCT07448922","A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors","An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignancies","Inclusion Criteria:\n\n1. Provide signed written informed consent and demonstrate understanding of and agreement to comply with study requirements and the study visit schedule.\n\n   Age\n2. Be ≥ 18 years and ≤ 75 years of age at the time of informed consent signing.\n\n   Participant Type and Disease Characteristics\n3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 within 2 weeks prior to first dose administration.\n4. Have a cytologically or histologically confirmed gynecologic malignancy.\n\n   * Cohort A: Ovarian cancer (OC) (including fallopian tube cancer and primary peritoneal cancer) with epithelial ovarian carcinoma histology, previously treated with 2-4 lines of systemic therapy, excluding primary platinum-resistant ovarian cancer (defined as disease recurrence or progression during first-line platinum-containing therapy, or disease recurrence or progression occurring \\\u003C182 days from the last platinum-containing therapy in the first line).\n   * Cohort B: Cervical cancer or endometrial cancer that has failed standard therapy or is intolerant to standard therapy, or for which no standard therapy exists.\n   * Cohort C: Platinum-sensitive ovarian cancer (PSOC) previously treated with 2-4 lines of systemic therapy.\n   * Cohort D: PSOC previously treated with 1-2 lines of systemic therapy.\n   * Cohort E Safety Lead-in Phase: PSOC previously treated with 2-4 lines of systemic therapy.\n   * Cohort E Expansion Phase: PSOC participants who have achieved Complete Response (CR),Partial Response (PR), or Stable Disease (SD) after 2 lines of therapy (platinum-based doublet regimen combined with bevacizumab), and require randomization within 8 weeks after the last dose.\n\n   Participants in Cohorts A, C, D, and E with known breast cancer susceptibility gene (BRCA) mutations must have received poly(ADP-ribose) polymerase (PARP) inhibitor therapy, unless contraindicated.\n\n   Note:\n   1. PSOC is defined as radiographic progression\u002Frecurrence occurring ≥6 months after the last platinum-containing chemotherapy, i.e., the interval from the date of the last platinum therapy to radiographic evidence of disease progression per RECIST v1.1 should be ≥6 months (182 days).\n   2. Line counting rules for OC are as follows:\n\n      * Adjuvant ± neoadjuvant therapy is considered 1 line of systemic antineoplastic therapy.\n      * Maintenance therapy (e.g., bevacizumab, PARP inhibitors) as part of frontline antineoplastic therapy is not counted as a separate line.\n      * Treatment regimen changes due to intolerance toxicity rather than disease progression are considered part of the same prior treatment line and are not counted as a separate line.\n5. Provide approximately 10-13 unstained consecutive tumor tissue slides during the screening period for gene expression level testing (preferably from recently obtained tissue). If fresh tumor tissue samples are unavailable, archived tumor tissue samples obtained within 2 years prior to first study dose administration may be provided. If a participant is unable to provide archived tumor tissue samples within 2 years prior to first dose, or unable to provide a sufficient number of unstained consecutive tumor tissue slides, the investigator must discuss with the medical monitor to determine whether earlier obtained tumor tissue samples or a reduced number of slides may be accepted. Fine-needle aspiration biopsy specimens or core biopsies are insufficient for biomarker testing. Cell smears from centrifuged thoracic\u002Fabdominal\u002Fpelvic\u002Fpericardial effusion drainage, and bone lesions without soft tissue components or from decalcified bone tumor specimens are also unacceptable.\n6. Have at least one target lesion per RECIST v1.1 criteria, accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast preferred) with a longest diameter ≥10 mm (except for lymph nodes, which must have a short axis ≥15 mm), and the lesion must be suitable for repeated accurate measurement. Lesions located in previously irradiated areas or that have undergone biopsy may serve as measurable target lesions if there is documented evidence of disease progression per RECIST v1.1. Brain lesions are not considered target lesions.\n7. Have an estimated life expectancy ≥12 weeks as assessed by the investigator.\n8. Demonstrate adequate bone marrow, hepatic, renal, and coagulation function based on laboratory tests performed within 7 days prior to first dose (hematology tests required within 3 days prior to first dose) \\[supportive treatments, including transfusions, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), thrombopoietin (TPO), TPO receptor agonists (TPO-RA), and interleukins, are not permitted within 14 days prior to first dose\\]:\n\n   1. Hematology: Absolute neutrophil count (NEUT) ≥1.5×10⁹\u002FL; Platelet count (PLT) ≥100×10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n   2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×upper limit of normal (ULN); for participants with hepatic metastases, ALT and AST ≤5×ULN; Total bilirubin (TBIL) ≤1.5×ULN and direct bilirubin (DBIL) ≤1.5×ULN;\n   3. Renal function: Serum creatinine (Cr) ≤1.5×ULN, or calculated creatinine clearance ≥60 mL\u002Fmin using the Cockcroft-Gault formula (see Appendix 4); Urinalysis indicating urine protein \\\u003C2+; for participants with urine protein ≥2+ on baseline urinalysis, a 24-hour urine collection should be performed with protein content \\\u003C1 g in 24 hours (if both testing methods are used, the 24-hour urine collection value will be used to determine eligibility);\n   4. Coagulation function: International normalized ratio (INR) ≤1.5; Activated partial thromboplastin time (aPTT) and prothrombin time (PT) ≤1.5×ULN.\n9. Have a left ventricular ejection fraction (LVEF) ≥50% by echocardiography (ECHO) within 28 days prior to first study drug administration.\n10. Have recovered from all toxicities due to prior therapy (i.e., improved to Grade 0 or 1, or to levels specified in the eligibility criteria). Participants with unresolved, stable chronic (\\>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.\n\n    Gender and Contraceptive Requirements\n11. Participants must agree to use highly effective contraception during study treatment.\n\nNote: The reliability of abstinence as required in the eligibility criteria must be evaluated based on the duration of the clinical study and the participant's preferred and usual lifestyle. Periodic abstinence (e.g., calendar method, ovulation method, symptothermal method, or post-ovulation method) is not an acceptable contraceptive method.\n\nFemale participants eligible for study participation must be non-pregnant (see Appendix 3), non-lactating, and meet at least one of the following conditions:\n\n* Not a woman of childbearing potential (WOCBP) as defined in Appendix 3. OR\n* A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 from the time of informed consent signing through at least 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\nPrior\u002FCurrent Study Experience\n\n1. Participation in any other interventional clinical study, except for observational (non-interventional) studies or follow-up periods of interventional studies.\n\n   Disease Characteristics\n2. For participants with ovarian cancer, mixed tumors containing sarcomatous components or borderline ovarian tumors.\n\n   \\- For participants in Cohorts C-E, mixed tumors containing high-grade serous carcinoma components and other components, or endometrioid, clear cell, mucinous, or sarcomatous histology, or mixed tumors containing any of the above histological types, or low-grade\u002Fborderline ovarian tumors.\n\n   Prior\u002FConcomitant Therapy\n3. Prior receipt of any of the following treatments:\n\n   a) Any drug therapy targeting topoisomerase I, including irinotecan, topotecan hydrochloride for injection, antibody-drug conjugates (ADCs) containing topoisomerase I, etc.\n4. Receipt of other antineoplastic therapy within 4 weeks prior to first study drug administration, including systemic chemotherapy, targeted therapy, immunotherapy, intraperitoneal perfusion chemotherapy, tumor embolization, or interventional chemotherapy, etc. For oral PARP inhibitors and traditional Chinese medicines indicated for antineoplastic therapy, the washout period is 2 weeks or 5 half-lives, whichever is longer.\n5. Receipt of strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors (see Appendix 8) within 2 weeks prior to first dose or within 5 half-lives of the known drug, whichever is longer.\n6. Receipt of live vaccine vaccination within 4 weeks prior to first study drug administration, or planned receipt of any live vaccine during the study.\n7. Persistence of adverse reactions from prior antineoplastic therapy that have not resolved to Grade 0, Grade 1, or baseline status per NCI-CTCAE v5.0 criteria prior to first study drug administration. Participants with unresolved, stable chronic (\\>3 months) toxicities not considered a safety risk (e.g., alopecia, hyperpigmentation, vitiligo) may be enrolled.\n8. Major surgery (craniotomy, thoracotomy, or laparotomy, and other surgical types considered \"major\" by the investigator, excluding needle biopsy) within 4 weeks prior to first study drug administration, or anticipated major surgery during the study, or presence of serious unhealed wounds, trauma, or ulcers, etc.\n\n   Note: Palliative local surgical treatment for isolated lesions is acceptable.\n9. Palliative radiotherapy within 2 weeks prior to first drug administration, or definitive radiotherapy within 4 weeks prior to first drug administration.\n10. Any condition requiring systemic corticosteroid therapy (dose \\>10 mg\u002Fday prednisolone or equivalent) or other immunosuppressive therapy within 14 days prior to first study drug administration. Participants receiving intranasal, inhaled, topical, or local glucocorticoid injections (e.g., intra-articular injections), or glucocorticoids as prophylaxis for hypersensitivity reactions may be enrolled.\n\n    Medical Conditions\n11. Known symptomatic central nervous system (CNS) metastasis and\u002For spinal cord compression and\u002For carcinomatous meningitis, or history of leptomeningeal carcinomatosis. Participants with asymptomatic CNS metastases (no neurological symptoms, no corticosteroid treatment required, and all metastatic lesions ≤1.5 cm in diameter) or with brain metastases that have been treated and are stable may be considered for enrollment if all of the following criteria are met: (a) Measurable disease outside the CNS; (b) No midbrain, pons, cerebellum, meninges, medulla oblongata, or spinal cord metastases; (c) Stable condition for at least 4 weeks with no new or enlarging metastases (clearly documented by clinical evidence); (d) Discontinuation of corticosteroids or anticonvulsants at least 2 weeks prior to first study drug administration. CNS lesions should be monitored regularly during the study.\n12. History of corticosteroid-treated pneumonitis, or history of other clinically significant pulmonary disease (e.g., interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary disease such as pulmonary fibrosis, severe radiation pneumonitis, and acute lung injury), or participants with suspected such disease on imaging during screening; clinically significant pulmonary function impairment due to concurrent pulmonary disease, including but not limited to: any serious underlying pulmonary disease (e.g., severe asthma, severe chronic obstructive pulmonary disease, or restrictive lung disease), or any autoimmune disease, connective tissue disease, or inflammatory disease potentially involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.).\n13. Presence of the following conditions:\n\n    1. Infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first study drug administration; serious infection within 4 weeks prior to first study drug administration, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n    2. Human immunodeficiency virus (HIV) infection, or HIV-positive (HIV 1\u002F2 Ab positive);\n    3. Acute or chronic active hepatitis B, defined as positive hepatitis B surface antigen (other antigen\u002Fantibody results unrestricted) or positive hepatitis B core antibody only (negative hepatitis B surface antibody and negative hepatitis B e antibody), with HBV DNA copy number ≥1×10⁴ copies\u002FmL or ≥2000 IU\u002FmL; acute or chronic active hepatitis C, defined as positive hepatitis C virus (HCV) antibody with HCV RNA titer above the lower limit of detection;\n    4. Symptomatic coronavirus disease 2019 (COVID-19) infection requiring treatment or resulting in hospitalization, such as fever, dyspnea, nausea, vomiting, diarrhea, etc.;\n    5. Active tuberculosis infection, or currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to first study drug administration;\n    6. Active syphilis infection or latent syphilis requiring treatment;\n    7. Uncontrolled myocarditis, or symptomatic congestive heart failure Grade II-IV (New York Heart Association \\[NYHA\\] criteria), symptomatic or uncontrolled arrhythmias such as ventricular tachycardia, atrial fibrillation, ventricular fibrillation, torsades de pointes, etc., QTc interval \\>480 ms, personal or family history of congenital long\u002Fshort QT syndrome;\n    8. Uncontrolled hypertension despite standardized treatment or uncontrolled despite standardized treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);\n    9. Gastrointestinal tract \\[referring to the muscular tube from mouth to anal canal, including oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum), and anal canal\\] or tracheal lumen stent implantation;\n    10. Significant malnutrition, such as requiring intravenous nutritional supplementation due to malnutrition; except if malnutrition was corrected \\>4 weeks prior to first study treatment.\n    11. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism within 3 months prior to first study drug administration (thrombosis due to implanted venous access ports or catheter-related thrombosis, or superficial venous thrombosis are not considered serious thromboembolism).\n    12. History of any arterial thromboembolic event within 6 months prior to first study drug administration, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.\n    13. Bleeding within 3 months prior to first study drug administration that was life-threatening, required transfusion, or required invasive treatment.\n    14. Symptomatic pelvic\u002Fabdominal effusion (excluding pelvic\u002Fabdominal effusion due to ovarian cancer itself), pleural effusion, or pericardial effusion requiring intervention (participants with stable, controlled effusion are permitted, defined as no significant increase in effusion volume and no clinical symptoms for at least 7 days with drainage tube removed or without drainage).\n    15. Participants with biliary obstruction unless local treatment for the obstruction has been performed (e.g., endoscopic stent placement or percutaneous transhepatic drainage) and TBIL has decreased to below 1.5×ULN.\n    16. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or higher cirrhosis.\n    17. History of prior gastrointestinal perforation or fistula formation, unhealed gastrointestinal obstruction, or participants at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis, abdominal abscess, history of abdominal cancer), participants with recurrent gastrointestinal obstruction (defined as ≥2 episodes of gastrointestinal obstruction within one year, or prior gastrointestinal obstruction in 2 consecutive years), or history of the following conditions: extensive bowel resection (partial colectomy or extensive small bowel resection with concurrent chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.\n    18. Clinically significant proteinuria.\n    19. History of severe dry eye, meibomian gland disease (MGD) and\u002For blepharitis, keratoconjunctivitis sicca (KSC), corneal disorders causing non-healing or delayed healing of the cornea, or macular disorders. Or determination of keratoconjunctivitis and\u002For corneal ulcer on ophthalmologic examination during screening, and presence of active or chronic corneal disease, other active eye disease requiring continuous treatment, or any clinically significant corneal disease preventing adequate monitoring of drug-induced keratopathy.\n14. Known hypersensitivity to study drug or any of its components \\[including polysorbate 80 (II)\\], or history of serious allergic reaction to other monoclonal antibodies; known history of platinum hypersensitivity for Cohort C; known history of platinum or bevacizumab hypersensitivity for Cohort D; known history of bevacizumab hypersensitivity for Cohort E; and hypersensitivity to both CT and MRI contrast agents, or inability to undergo contrast-enhanced CT and contrast-enhanced MRI for any reason.\n15. History of immunodeficiency disorders, including congenital or acquired immunodeficiency diseases.\n16. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n17. Pregnant or lactating women.\n\n    Tumor History\n18. Participants with known other malignancies progressing within the past 5 years or requiring active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ with no evidence of disease recurrence.\n19. Tumor invasion of surrounding vital organs or tissues (e.g., mediastinal great vessels, superior and inferior vena cava, pericardium, heart, trachea, esophagus, etc.) and\u002For risk of gastrointestinal, respiratory, or other fistulas due to any cause.\n\n    Other Exclusion Criteria\n20. Presence of other acute or chronic diseases or laboratory abnormalities that may increase the risk of study participation or administration, or interfere with interpretation of study results; presence of neurological, psychiatric, or social conditions affecting trial compliance, significantly increasing the risk of adverse events, or affecting the participant's ability to provide written informed consent.\n21. Acute or chronic diseases or laboratory abnormalities that the investigator judges unsuitable for study participation, or any condition that the investigator believes interferes with evaluation of study drug, participant safety, or interpretation of study results, or any other condition that the investigator believes makes the participant unsuitable for this study.","FEMALE","18 Years","75 Years",{"count":20,"type":21},280,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter, Phase II clinical study to evaluate the efficacy and safety of SKB518 as monotherapy or combination therapy in patients with advanced gynecological malignancies.\n\nThis study will include 5 cohorts: SKB518 as monotherapy in advanced ovarian cancer; SKB518 as monotherapy in advanced cervical cancer and endometrial cancer; SKB518 in combination with Carboplatin in advanced ovarian cancer; SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer; and SKB518 in combination with Bevacizumab in advanced ovarian cancer.\n\nStudy hypothesis: SKB518 will show meaningful clinical activity and a favorable risk benefit profile in gynecological malignancies.",[27],"Advanced Gynecological Malignancies","RECRUITING","2026-05-07",{"date":31,"type":32},"2026-05-12","ACTUAL",{"date":34,"type":32},"2026-04-08",{"date":36,"type":21},"2028-09-30",{"name":38,"class":39},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"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.",{"count":48,"type":21},56,[24],"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.",[27],"NOT_YET_RECRUITING","2025-12-22",{"date":55,"type":32},"2025-12-31",{"date":57,"type":21},"2025-12",{"date":59,"type":21},"2028-11",{"name":61,"class":39},"BioRay Pharmaceutical Co., Ltd."]