[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,66,92,114],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100627931","phase-1-a-phase-i-study-of-fz-ad005-in-patients-with-high-grade-glioma-hgg-100627931",false,"NCT07455045","A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG)","An Open-Label, Multicenter, Phase I Study of FZ-AD005 Antibody-Drug Conjugate in Patients With Recurrent\u002FRefractory High-Grade Glioma (HGG)","Inclusion Criteria:\n\n1. Voluntarily signed Informed Consent Form;\n2. Age 18-70 years, both male and female;\n3. Patients must be able to provide tumor tissue samples (archived tumor tissue within 2 years \\[maximum 5 years\\] or fresh core needle biopsy specimen, if possible) for DLL3 testing, with positive assessment results;\n4. Histopathologically confirmed high-grade glioma, classified according to WHO CNS5 2021 criteria, meeting one of the following characteristics:\n\n   Group A (Post-radiotherapy maintenance phase): Diffuse midline glioma (DMG), with H3 K27 alterated by CLIA-certified laboratory; Patients must be in the maintenance treatment phase following new diagnosis and completion of standard first-line radiotherapy; Group B (Recurrent or progressive high-grade glioma): Recurrent or progressive high-grade glioma (WHO CNS5 Grade 3-4). Including but not limited to: IDH wild-type glioblastoma (GBM), IDH-mutant astrocytoma (Grade 3-4), IDH-mutant oligodendroglioma (Grade 3), etc. (Note: Recurrent or progressive DMG patients may be enrolled in this group during dose escalation phase);\n5. Prior treatment status:\n\n   Group A (Post-radiotherapy maintenance phase): Must have completed standard radiotherapy, with enrollment occurring within 2-6 weeks after radiotherapy completion, and no definitive evidence of progressive disease (PD) on post-radiotherapy imaging; Group B (Recurrent or progressive high-grade glioma): Must be recurrent or refractory patients who have failed standard treatment: must have received at least one prior line of standard treatment (including radiotherapy and\u002For chemotherapy, such as temozolomide), with an imaging evidence of PD; for patients with prior radiotherapy, disease progression must occur \\>12 weeks after radiotherapy, or must be histopathologically confirmed as tumor recurrence rather than necrosis\u002Fpseudoprogression by radiotherapy;\n6. At least one measurable lesion at baseline (RANO 2.0 )\n7. Karnofsky Performance Status (KPS) score ≥70 (if patient has slightly lower score solely due to stable focal neurological deficits but can maintain basic daily living with support, 60 is approval);\n8. If patient is receiving corticosteroids for tumor-related cerebral edema or neurological symptoms, dosage must be stable or decreasing for at least 7 days prior to baseline MRI, with dose ≤5 mg\u002Fday dexamethasone (or equivalent dose of other corticosteroids); if increased steroid dosage is required during screening to control cerebral edema due to clinical deterioration, the patient is ineligible;\n9. Estimated life expectancy ≥12 weeks;\n10. Normal coagulation function, with no risk of active bleeding;\n11. Cardiopulmonary function: Left ventricular ejection fraction (LVEF) ≥50%; pulse oxygen saturation (SpO2) ≥95% on room air at rest, with no dyspnea at rest;\n12. Bone marrow reserve and organ function must meet the following requirements:\n\n    Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL (without transfusion, erythropoietin \\[EPO\\], granulocyte colony-stimulating factor \\[G-CSF\\], or other medical supportive treatment within 14 days prior to screening); Coagulation: For subjects not receiving anticoagulation therapy, prothrombin time international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×upper limit of normal (ULN) (Note: Subjects receiving stable anticoagulation therapy are allowed if parameters are within therapeutic range and no bleeding risk); Liver: Total serum bilirubin ≤1.5×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; if Gilbert's syndrome (unconjugated hyperbilirubinemia) is confirmed, total bilirubin ≤3.0×ULN; AST and ALT ≤3×ULN; Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated by Cockcroft and Gault formula);\n13. All acute toxicities from prior antitumor therapy or surgical procedures must have resolved to baseline severity or NCI CTCAE Version 6.0 Grade ≤1;\n14. Within 7 days prior to enrollment, women of childbearing potential must have negative serum or urine pregnancy test; male and female subjects must agree to use effective contraception (e.g., oral contraceptives, intrauterine device, abstinence, or barrier contraception with spermicide) during study drug administration and for 6 months after the last dose;\n15. Good compliance.\n\nExclusion Criteria:\n\n1. Prior treatment with other anti-DLL3 targeted antibody therapies or other DLL3-directed treatments, or ADC drugs containing DXd payload;\n2. History of allergic reaction to exatecan or ≥Grade 3 gastrointestinal toxicity following prior exatecan use, or hypersensitivity to protein components structurally similar to FZ-AD005, or hypersensitivity to excipients of the FZ-AD005 investigational drug;\n3. Subjects with any contraindications to magnetic resonance imaging (MRI) (e.g., cardiac pacemaker, non-removable metal implants, etc.);\n4. History of other malignancies within the past 3 years (except for specific low-risk tumors that have been radically treated);\n5. Failure to meet the following washout period requirements prior to first dose:\n\n   Chemotherapy (non-nitrosourea), small molecule targeted therapy: ≤3 weeks (21 days) or 5 half-lives (whichever is longer); Nitrosoureas (e.g., lomustine) or mitomycin C: ≤6 weeks (42 days); Immune checkpoint inhibitors (ICI), antibody drugs (including other ADCs): ≤4 weeks (28 days) or 5 half-lives (whichever is longer); Anti-angiogenic therapy (e.g., bevacizumab): ≤5 weeks (35 days); Radiotherapy: For Treatment Group B: whole brain or involved-field radiotherapy ≤12 weeks; palliative radiotherapy (non-intracranial target lesions) ≤2 weeks (Note: For Treatment Group A subjects, standard first-line radiotherapy prior to this enrollment is not subject to this 12-week restriction, but must meet the specific window requirement for time since radiotherapy completion as stated in the inclusion criteria);\n6. Receipt of live vaccine within 4 weeks prior to first dose;\n7. Active infection requiring drug intervention within 2 weeks prior to first dose, or unexplained fever \\>38°C with elevated procalcitonin results between screening and first dose (subjects with tumor-related fever may be enrolled at investigator's discretion);\n8. Severe mass effect or risk of brain herniation, defined as: baseline MRI showing midline shift \\>5 mm, or signs of uncontrolled intracranial hypertension\u002Fhydrocephalus; or investigator's judgment that the patient cannot tolerate any degree of treatment-induced cerebral edema;\n9. Extracranial metastases or diffuse leptomeningeal disease confirmed by imaging (MRI)\u002Fcerebrospinal fluid (CSF) cytology;\n10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage despite appropriate intervention;\n11. History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis requiring steroid treatment, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be excluded by imaging at screening;\n12. Serious cardiovascular or cerebrovascular disease or history (including but not limited to the following):\n\n    Myocardial infarction or unstable angina within 6 months prior to first dose; Congestive heart failure with cardiac function ≥Grade II (NYHA classification); Uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg); Baseline QTcF \\>450 ms (male) or \\>470 ms (female); Clinically significant arrhythmia or conduction block requiring drug treatment;\n13. Other serious systemic diseases, including but not limited to diabetes mellitus not effectively controlled;\n14. Subjects with poorly healing wounds, ulcers, or fractures;\n15. Patients who underwent major surgery or serious trauma within 4 weeks prior to first dose;\n16. Receipt of autologous organ or stem cell transplantation within 3 months prior to first dose, or allogeneic organ (except corneal transplantation) or stem cell transplantation within 6 months prior to first dose;\n17. Hepatitis B surface antigen (HBsAg) positive with HBV DNA \\>2000 IU\u002FmL or 10⁴ copies\u002FmL. If HBsAg positive but with low DNA, should receive antiviral treatment according to local treatment guidelines and be willing to receive antiviral treatment throughout the study period; Hepatitis C antibody positive with HCV RNA above the upper limit of normal of the study center;\n18. Active tuberculosis, active syphilis, history of immunodeficiency, positive human immunodeficiency virus (HIV) antibody, or other immunodeficiency diseases;\n19. Requirement for systemic corticosteroids (\\>5 mg\u002Fday dexamethasone or equivalent dose of similar drugs) or other immunosuppressants for systemic treatment within 2 weeks prior to first dose or during the study; Note: Topical and inhaled corticosteroids with minimal systemic absorption are permitted; corticosteroids ≤5 mg\u002Fday dexamethasone (or equivalent dose) for physiological replacement therapy or treatment of tumor-related symptoms are permitted, provided the subject has stable or decreasing dosage for at least 7 days prior to baseline MRI; short-term (≤7 days) corticosteroids for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to contact allergens) are permitted;\n20. Definite history of mental illness;\n21. Known history of psychoactive substance abuse, alcoholism, or drug addiction;\n22. Pregnant or lactating women;\n23. Uncontrolled seizures (seizure within 14 days prior to enrollment or requirement for increased antiepileptic drug dosage);\n24. Clinically significant intracranial hemorrhage (\\>Grade 1 acute\u002Fsubacute hemorrhage);\n25. Any other condition that the investigator considers unsuitable for participation in this clinical study.","ALL","18 Years","70 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","An Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with HGG, especially in DMG and other Recurrent HGG.",[27,28,29],"High Grade Glioma (III or IV)","Diffuse Midline Glioma (DMG)","Glioblastoma (GBM)","NOT_YET_RECRUITING","2026-03-02",{"date":33,"type":34},"2026-03-06","ACTUAL",{"date":36,"type":21},"2026-03-01",{"date":38,"type":21},"2028-06-01",{"name":40,"class":41},"Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100548720","phase-1-a-study-of-fz-ad005-in-patients-with-advanced-solid-tumors-100548720","NCT06424665","A Study of FZ-AD005 in Patients With Advanced Solid Tumors","A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD005 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients able to give written informed consent;\n2. Age ≥ 18 and ≤ 75 years old, male or female;\n3. Patients have histological or cytological diagnosis with advanced solid tumors ( especially SCLC or LCNEC);\n4. Willingness to provide tumor tissue for testing ;\n5. Have measurable lesions defined in RECIST v. 1.1;\n6. Expected survival ≥ 3 months;\n7. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;\n8. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.\n\nExclusion Criteria:\n\n1. Patients who have had previous treatment with any anti-DLL3 antibody；\n2. Have had other malignant tumors in the past 5 years;\n3. Patients who are receiving other anti-tumor treatments within 4 weeks prior to the first dose;\n4. Have active CNS (central nervous system) metastasis；\n5. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;\n6. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;\n7. Patients have psychiatric history;\n8. Female patients who are breastfeeding or pregnant;\n9. Other reasons that researchers believe are inappropriate to participate in this study.","75 Years",{"count":52,"type":21},162,[24],"A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.",[56],"Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)","RECRUITING",{"date":59,"type":34},"2026-03-04",{"date":61,"type":34},"2024-07-03",{"date":63,"type":21},"2027-12-01",{"name":40,"class":41},3,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":5},"100452468","phase-2-a-study-to-evaluate-efficacy-and-safety-of-light-dose-in-subjects-with-pwb-treated-with-hemoporfin-pdt-100452468","NCT05171894","A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT","A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose in Subjects With Port-wine Birthmarks Treated With Hemoporfin Photodynamic Therapy","Inclusion Criteria:\n\n1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.\n2. Subject is Fitzpatrick skin type I-VI.\n3. A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.\n4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n   Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 30 days after the last dose of study treatment.\n5. The subject has a clinical diagnosis of PWB located i) on the extremities, trunk, caudal cervical and\u002For retroauricular area (Stage One); ii) on the face and\u002For neck (Stage Two).\n6. The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2 cm.\n7. Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n8. Subject, in the Investigator's opinion, is in good general health and free of any disease state or physical condition that may impair the evaluation of PWB or expose the subject to an unacceptable risk by study participation.\n9. If the subject has a history of epilepsy or seizure, the disease must remain stable for at least 6 months prior to C1D1.\n\nExclusion Criteria:\n\n1. Subject is pregnant, lactating, or is planning to become pregnant during the study.\n2. Subject has plaque\u002Fnodular changes and severe hypertrophy within the target PWB area.\n3. Subject has Sturge-Weber syndrome.\n4. Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy.\n5. The subject has evidence of scarring within the target PWB area and\u002For the subject has a history of hypertrophic scarring or keloidal scarring.\n6. Subject is immunosuppressed related to medication use and\u002For disease.\n7. The subject has clinical abnormalities, as determined by the Investigator, which makes them unsuitable for receiving study treatment in the Investigator's opinion at Screening.\n8. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area.\n9. Subject is known or in the opinion of the Investigator likely to be noncompliant with the requirements of the study protocol (eg, due to alcoholism, drug dependency, mental incapacity).\n10. Subject has a history of either significant neurological events (such as major stroke) or a mental condition rendering him\u002Fher unable to understand the nature, scope, and possible consequences of the study.\n11. Subject has an unstable cardiac disease or has any medical condition that in the opinion of the Investigator may worsen from receipt of study treatment or subject participation.\n12. The subject has a history of cutaneous photosensitization, porphyria, or photodermatosis.\n13. The subject has the need or has plans to be exposed to artificial tanning devices or excessive sunlight during the study.",{"count":74,"type":21},84,[76],"PHASE2","This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 75 years old with PWB will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg\u002Fkg) and different light fluence.",[79,80,81],"Port-wine Birthmarks","Port-Wine Stain","Nevus Flammeus",[83,79,80,81,84],"Hemoporfin","Photodynamic therapy",{"date":86,"type":34},"2026-03-03",{"date":88,"type":34},"2024-09-21",{"date":90,"type":21},"2027-04",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":42},"100509524","phase-1-a-study-of-fz-ad004-in-patients-with-advanced-solid-tumors-100509524","NCT05914545","A Study of FZ-AD004 in Patients With Advanced Solid Tumors","A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FZ-AD004 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients able to give written informed consent;\n2. Age ≥ 18 and ≤ 75 years old, male or female;\n3. Patients have histological or cytological diagnosis with advanced solid tumors.\n4. Have measurable lesions defined in RECIST v. 1.1;\n5. Expected survival ≥ 12 weeks;\n6. Eastern Cancer Cooperative Group (ECOG) performance status 0-1;\n7. Patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment.\n\nExclusion Criteria:\n\n1. Have had other malignant tumors in the past 5 years;\n2. Have CNS (central nervous system) metastasis with clinical symptoms;\n3. Had undergone major surgery or severe trauma within 4 weeks prior to the first dose;\n4. Had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment;\n5. Have history of psychotropic drug abuse, alcohol or drug abuse；\n6. Women who are pregnant or lactating；\n7. Other circumstances that is deemed not appropriate for the study.",{"count":100,"type":21},121,[24],"This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.",[104],"Advanced and Metastatic Solid Tumor",[104],"2026-01-20",{"date":108,"type":34},"2026-01-22",{"date":110,"type":34},"2023-06-12",{"date":112,"type":21},"2027-12",{"name":40,"class":41},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":42},"100547872","phase-2-a-study-of-fda022-bb05-in-advancedmetastatic-solid-tumors-100547872","NCT06413615","A Study of FDA022-BB05 in Advanced\u002FMetastatic Solid Tumors","A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients with Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Subjects fully understand and voluntarily participate in this study and sign informed consent.\n\nLeft Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days prior to first dose.\n\nEastern Cooperative Oncology Group performance status( PS) of 0 or 1. Life expectancy ≥ 3 months.\n\nHistopathologically or cytologically confirmed advanced\u002Funresectable or metastatic solid malignant tumors that is refractory to or intolerable with standard treatment, or for which no standard treatment is available:\n\nCohort A: Pathologically documented breast cancer that:\n\n* Is unresectable or metastatic.\n* Has a history of low HER2 expression, defined as IHC 2+\u002FISH- or IHC 1+ (ISH- or untested).\n* For HR-positive participants, is documented refractory to endocrine therapy, defined as having progressed on at least 1 endocrine therapy and determined by the investigator that subject would no longer benefit from further treatment from endocrine therapy.\n* Was never previously HER2-positive(IHC 3+ or IHC 2+\u002FISH+) on prior pathology testing or was historically HER2 IHC 0 only.\n\nCohort B: Pathologically documented endometrial cancer that:\n\n* Is unresectable or metastatic.\n* Has a history of HER2 expression, defined as HER2 1+, 2+, or 3+ score on immunohistochemistry (IHC).\n* Have had at least one prior line of platinum-based therapy (in any setting).\n* Was never previously received other ADC anti-tumor treatment.\n\nCohort C: Metastatic or advanced solid tumor that are HER2 overexpression or mutation(Including urothelial cancer, colorectal adenocarcinoma and non-small cell lung cancer).\n\nExclusion Criteria:\n\n* A treatment history of antibody-drug conjugate containing topoisomerase I inhibitors.\n\nSubjects with one of the following conditions prior to first dose, including, but not limiting to：A major operation or severe trauma history within 4 weeks; A history of chemotherapy, targeted therapy, anti-angiogenesis therapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 4 weeks; A history of endocrine therapy within 3 weeks; A history of autologous stem cell transplant within 3 months.\n\nSubjects with other malignant tumors in the past three years (not including cured non-melanoma skin basal cell carcinoma, cervical carcinoma in situ and other malignancies of low malignant potential that have been effectively controlled without treatment).\n\nSubjects with symptomatic CNS metastasis (for example, cerebral edema requiring glucocorticoids therapy, or progressive CNS metastasis), not including prior cerebral and meningeal metastasis that is confirmed stable with MRI and without systematic glucocorticoids therapy.\n\nAdverse reactions from the previous anti-tumor treatment have not yet recovered (\\>Grade 2 in NCI-CTCAE 5.0, with exception of alopecia and pigmentation or other adverse reactions judged no safety risk by the investigator).\n\nSubjects with clinically significant cardiovascular or cerebrovascular disease, including, but not limiting to:\n\na medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.\n\na medical history of myocardial infarction or unstable angina within 6 months prior to screening; a QTc prolongation to \\> 450 millisecond (ms) in males and \\> 470 ms in females.\n\nSubjects with a medical history of interstitial lung disease (ILD)\u002Fpneumonia in need of glucocorticoids intervention，or with interstitial lung disease, or suspicious ILD by imaging detection at screening.\n\nSubjects with any uncontrolled active infection within 1 week prior to first dose.\n\nSubjects with concomitant disease potentially increasing toxicological risk. Known allergy to protein preparation or any protein drug with similar structure to FDA022-BB05.\n\nSubjects with a History of alcohol abuse or psychotropic\u002Fnarcotic drug abuse; Pregnant or lactating women. Subjects with poor compliance, or not suitable for this study as determined by the investigator due to other reasons.",{"count":122,"type":21},150,[76],"This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing\u002Fexpressing solid tumors which are not eligible for curative therapy.",[126],"Advanced Solid Tumor","2024-09-24",{"date":129,"type":34},"2024-09-26",{"date":131,"type":34},"2024-05-13",{"date":133,"type":21},"2026-06-30",{"name":40,"class":41},""]