[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Huaota Biopharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":227},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,69,92,115,139,160,181,204],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100627478","phase-1-a-study-to-evaluate-efficacy-and-safety-of-hb0043-in-aadult-patients-with-moderate-to-severe-acne-vulgaris-100627478",false,"NCT07449156","A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.","A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Acne Vulgaris (AV).","Inclusion Criteria:\n\n\\- 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosed with mild to moderate facial acne vulgaris; 4. Throughout the study period, participants must refrain from using concomitant acne therapies.\n\n5\\. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.\n\nExclusion Criteria:\n\n* 1\\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.\n\n  3\\. Participant has any facial skin disease other than common acne. 4. Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 5. Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris; 6. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 7. History of recurrent or recent serious infection; 8. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 9. Pregnant or lactating women; 10. Any reason why, in the opinion of the investigator, the patient should not participate.",true,"ALL","18 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.",[28],"Acne Vulgaris","NOT_YET_RECRUITING","2026-02-27",{"date":32,"type":33},"2026-03-04","ACTUAL",{"date":35,"type":21},"2026-03-27",{"date":37,"type":21},"2027-03-27",{"name":39,"class":40},"Shanghai Huaota Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":41},"100622399","phase-3-phase-iii-clinical-study-of-hb0025-combined-with-chemotherapy-versus-tislelizumab-combined-with-chemotherapy-as-first-line-treatment-for-advanced-nonsquamous-non-small-cell-lung-cancer-100622399","NCT07383116","Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer","A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Injection Combined With Chemotherapy Versus Tislelizumab Combined With Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Able to fully understand and voluntarily sign the informed consent form, and willing and able to comply with the clinical study procedures and follow-up visits.\n2. Aged 18 to 75 years old (inclusive of both upper and lower limits), male and female subjects are eligible.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n4. Expected survival ≥ 12 weeks.\n5. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control \\[UICC\\] and the American Joint Committee on Cancer \\[AJCC\\]), which is inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy as well as immunotherapy as consolidation treatment.\n\n   Note: For subjects with locally advanced (Stage IIIB\u002FIIIC) non-squamous NSCLC who are inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy as well as immunotherapy as consolidation treatment, assessment by relevant specialist physicians and provision of written documentation are required for confirmation.\n6. No prior systemic antineoplastic treatment for the study disease (including systemic chemotherapy, targeted therapy, and immunotherapy).\n\n   Note: Subjects who previously received neoadjuvant, adjuvant, or radical concurrent\u002Fsequential chemoradiotherapy for non-metastatic disease with curative intent are eligible if disease progression occurs \\> 180 days after the last dose of prior treatment.\n7. Subjects must provide tumor tissue samples (archived or freshly obtained) collected at or after the diagnosis of locally advanced or metastatic tumor for central laboratory testing of PD-L1 expression.\n\n   Note: The following samples are not accepted: fine-needle aspiration samples (without intact tissue structure, only cell suspensions or smears), brush cytology samples, cell smears from centrifuged pleural effusion drainage, bronchoalveolar lavage fluid samples, and bone lesions without soft tissue components or decalcified bone tumor samples. Tumor lesions used for fresh tissue biopsy should not be designated as RECIST v1.1 target lesions, unless the lesion is the only measurable lesion. For archived samples, they must be collected after the last systemic treatment, and the collection site must not have received radiotherapy. If a subject's archived samples do not meet the above requirements and the investigator judges that a biopsy is not in the subject's best interest, the use of archived samples may be permitted after discussion with the sponsor.\n8. No sensitive EGFR mutations or ALK gene rearrangements. Prior tissue-based test reports for EGFR and ALK status must be provided. If the test reports do not meet the study requirements or are unavailable, tumor tissue samples must be provided for assessment of EGFR and ALK status (tested by a local laboratory recognized by the study site or the central laboratory) before enrollment.\n\n   Note: For subjects with squamous NSCLC (excluding mixed-type NSCLC, e.g., adenosquamous carcinoma) who have a smoking history or are current smokers, if the prior EGFR and ALK status is unknown, testing for these markers is not required before enrollment, and they will be deemed negative.\n9. Per RECIST v1.1 criteria (see Appendix 2), the subject must have at least one measurable (non-brain metastatic) lesion suitable for repeated and accurate measurement. Tumor lesions previously treated with radiotherapy or other local therapies must not be designated as target lesions, unless:\n\n   The lesion is the only measurable lesion, and the investigator can provide imaging evidence (both pre- and post-local treatment) confirming clear disease progression of the lesion following local therapy; The lesion used for fresh tissue biopsy must not be designated as a target lesion, unless it is the only measurable lesion and the biopsy date is more than 4 weeks prior to the first dose of study treatment.\n10. Confirmed adequate organ function, with mandatory compliance with the following laboratory parameters:\n\nHematology (no receipt of any blood component transfusion or hematopoietic growth factor support therapy within 14 days prior to screening tests):\n\n1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n2. Platelet Count (PLT) ≥ 100 × 10⁹\u002FL;\n3. Hemoglobin (HGB) ≥ 90 g\u002FL;\n\nRenal function:\n\n1. Serum Creatinine (Scr) ≤ 1.5 × Upper Limit of Normal (ULN), and Creatinine Clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 3 for details);\n2. Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein excretion must be \\\u003C 1 g;\n\nHepatic function:\n\n1. Serum Total Bilirubin (TBiL) ≤ 1.5 × ULN; for subjects with liver metastasis or confirmed Gilbert's syndrome, TBiL ≤ 3 × ULN;\n2. Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastasis, ALT and AST ≤ 5 × ULN;\n3. Serum Albumin (ALB) ≥ 30 g\u002FL; Coagulation function: Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator must confirm that both INR and APTT are within the safe and effective therapeutic range); Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50%. 11. Female and male subjects of childbearing potential must agree to use effective contraceptive measures from the screening period until 90 days after the last dose of study treatment. Discussion with the investigator is required to determine whether contraception can be discontinued after this period. Female subjects must not be breastfeeding. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days before randomization.\n\nExclusion Criteria:\n\n1. Histologically confirmed presence of any small cell carcinoma, neuroendocrine carcinoma, or sarcoma components \\[mixed-type NSCLC (e.g., adenosquamous carcinoma) is permitted for enrollment\\].\n2. Known presence of driver gene alterations with approved first-line therapeutic options, such as sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.\n3. History of a second primary malignancy within 5 years before screening (enrollment is permitted for other malignancies cured by local treatment, e.g., carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, \\\u003C T1 urothelial carcinoma, and papillary microcarcinoma of the thyroid).\n4. Symptomatic central nervous system (CNS) metastasis. For subjects with asymptomatic CNS metastasis or those with symptomatically stable CNS metastasis for ≥ 4 weeks prior to randomization, enrollment is permitted only if all the following criteria are met:\n\n   * No metastasis to the meninges, midbrain, pons, medulla oblongata, spinal cord, or spinal cord compression; ② No increase in lesion size or new lesions after treatment;\n\n     * No history of intracranial hemorrhage;\n\n       * Discontinuation of corticosteroid therapy for ≥ 2 weeks prior to randomization; ⑤ No significant perilesional edema surrounding brain metastases; ⑥ The longest diameter of brain metastases ≤ 1.5 cm.\n5. Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1\u002FL2, anti-CTLA-4 agents), immune checkpoint agonists (e.g., ICOS, CD40, GITR, OX40, CD137 agents), or cellular immunotherapy, or any treatment targeting the tumor immune mechanism. Additionally, for subjects who previously received PD-(L)1 inhibitors in the neoadjuvant\u002Fadjuvant setting or as consolidation therapy after definitive chemoradiotherapy, enrollment may be permitted (with sponsor approval) if the interval between the end of the last treatment and the occurrence of disease progression is more than 12 months.\n\n   Note: For subjects with prior PD-(L)1 inhibitor exposure:\n\n   Enrollment is prohibited if the subject experienced ≥ Grade 3 immune-related adverse events (irAEs) caused by prior immunotherapy (excluding endocrine-related irAEs), irAEs leading to permanent treatment discontinuation, ≥ Grade 2 immune-related cardiotoxicity, or immune-related neurological or ophthalmic irAEs of any grade; Screening is prohibited if all adverse events caused by prior immunotherapy have not been fully resolved or resolved to Grade 1 before study screening. For subjects with ≥ Grade 2 endocrine-related irAEs, enrollment is permitted if the condition is stable and asymptomatic with appropriate replacement therapy.\n6. Prior receipt of systemic anti-angiogenic therapy, including but not limited to bevacizumab and its biosimilars, Endostar, small-molecule TKIs, and ramucirumab.\n7. Prior anti-tumor therapy or concomitant medication (the washout period is calculated from the end date of the last treatment):a) Participation in any clinical trial within 28 days prior to the first dose;b) Receipt of anti-tumor therapy within 4 weeks prior to the first dose or within 5 half-lives of the drug (whichever is longer), including but not limited to chemotherapy, radiotherapy (thoracic radiotherapy with a dose \\> 30 Gy within 180 days prior to the first dose; non-thoracic radiotherapy with a dose \\> 30 Gy within 4 weeks prior to the first dose; local palliative radiotherapy with a dose ≤ 30 Gy for non-target lesions within 2 weeks prior to the first dose), targeted therapy, immunotherapy, or endocrine therapy;c) Use of Chinese herbal medicines (including patent Chinese medicines) with anti-tumor indications within 2 weeks prior to the first dose; use of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to the first dose;d) Need for systemic administration of corticosteroids at a dose \\> 10 mg\u002Fday of prednisone or equivalent dose, or other immunomodulators within 2 weeks prior to randomization. \\[Short-term administration (≤ 7 days) for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by allergen exposure), or local administration (e.g., intraocular, intra-articular, intranasal, or inhaled administration) is permitted for enrollment\\];e) Use or current use of anticoagulants such as warfarin, heparin (excluding heparin for catheter locking or deep vein catheterization), dabigatran etexilate, rivaroxaban, etc., or antiplatelet drugs such as aspirin, clopidogrel, dipyridamole, cilostazol, or other known antiplatelet agents within 2 weeks prior to the first dose.\n8. Major surgery or severe trauma within 4 weeks before the first dose of study treatment; inadequate recovery from prior surgery (as judged by the investigator); anticipated need for major surgery during the study; minor local surgery (e.g., needle biopsy, endoscopy, interventional procedure\u002Fexamination, excluding vascular access establishment) within 7 days before randomization; presence of incompletely healed surgical incisions or wounds.\n9. Active autoimmune disease requiring systemic treatment (e.g., treatment with immunomodulators or corticosteroids) within 2 years before screening, except for replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).\n10. Presence of any of the following infections:\n\n    1. Severe infection (including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia) within 4 weeks before the first dose of study treatment; active infection requiring systemic anti-infective treatment (with antibiotics for ≥ 7 days) within 2 weeks before the first dose of study treatment;\n    2. Known active tuberculosis (TB) (subjects with suspected active TB must undergo clinical examination to rule out the diagnosis);\n    3. Known active syphilis infection;\n    4. Has a known history of HIV;\n    5. Active hepatitis B or hepatitis C; asymptomatic hepatitis B virus (HBV) carriers (HBV DNA ≤ 200 IU\u002Fml or ≤ 1000 copies\u002Fml or below the lower limit of detection, whichever is applicable) or subjects with clinically cured hepatitis C (HCV RNA below the lower limit of detection) are permitted for enrollment.\n\n    Note: Anti-HBV treatment is required for HBsAg-positive subjects during the study treatment period.\n11. Known hypersensitivity to protein drugs, recombinant proteins, components of HB0025, and\u002For components of chemotherapy drugs (pemetrexed and carboplatin\u002Fcisplatin).\n12. Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n13. Presence of any of the following severe comorbidities:\n\n    1. Clinically significant bleeding (including but not limited to hemoptysis \\[defined as coughing up or expectorating ≥ 1 teaspoon (approximately 5 ml) of fresh blood or small blood clots, or hemoptysis without sputum; subjects with blood-tinged sputum or transient hemoptysis related to diagnostic bronchoscopy or lung biopsy are permitted\\], gastrointestinal bleeding, nasal bleeding \\[subjects with bloody nasal discharge are permitted\\]) within 4 weeks before the first dose of study treatment; any arterial thrombosis or embolism event, or significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 180 days before the first dose of study treatment; history of deep vein thrombosis within 90 days before the first dose of study treatment;\n    2. Imaging findings at screening showing: Tumor invasion of large blood vessels (e.g., central pulmonary artery, central pulmonary vein, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava); tumor invasion of vital organs (e.g., heart, trachea, esophagus, main bronchus); or imaging evidence of risk for esophagotracheal fistula or esophagopleural fistula; tumor encasement of large blood vessels with vascular stenosis; or pulmonary lesions with obvious necrosis\u002Fcavitation (as judged by the investigator to pose a bleeding risk if enrolled);\n    3. History of persistent bleeding disorders or coagulation disorders (past or current);\n    4. Clinically significant (e.g., active) cardiovascular or cerebrovascular disease within 180 days prior to the first dose, including but not limited to unstable angina requiring hospitalization, myocardial infarction, myocarditis, cardiomyopathy, congestive heart failure of New York Heart Association (NYHA) Class ≥ III, poorly controlled severe arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or vascular disease (e.g., aortic aneurysm at risk of rupture); or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia). Prolonged Fridericia-corrected QT interval (QTcF) on electrocardiogram: \\> 450 ms for males and \\> 470 ms for females.\n    5. History of conditions potentially causing gastrointestinal bleeding or perforation (e.g., gastrointestinal obstruction, acute Crohn's disease, ulcerative colitis, esophagogastric varices, gastrointestinal perforation, unhealed wound, intra-abdominal abscess, or acute gastrointestinal bleeding) within 180 days before the first dose of study treatment; subjects with chronic Crohn's disease or ulcerative colitis (excluding those who have undergone total colectomy and proctectomy) are excluded, even if in remission;\n    6. History of gastrointestinal fistula or genitourinary fistula (past or current) that remains unhealed after surgical treatment;\n    7. Hydronephrosis unrelieved by nephrostomy or ureteral stenting, or infected hydronephrosis\u002Fhydroureter;\n    8. Current presence of third-space fluid collections (e.g., pleural effusion, pericardial effusion, abdominal\u002Fpelvic effusion) requiring repeated puncture\u002Fdrainage for local management; or receipt of local drainage within 2 weeks before the first dose of study treatment;\n    9. Acute exacerbation of chronic obstructive pulmonary disease within 30 days before the first dose of study treatment;\n    10. Current presence of uncontrolled comorbidities, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis (enrollment decision requires joint discussion between the investigator and the sponsor).\n14. Current presence of interstitial lung disease, pneumoconiosis, or drug\u002Fradiotherapy-related pneumonia requiring treatment.\n15. Unresolved adverse events from prior treatment (defined as adverse events not resolved to Grade 0 or 1 per the National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] Version 5.0, or to the level specified in the inclusion\u002Fexclusion criteria), except for alopecia. Subjects with irreversible toxicity (e.g., hearing loss) that is not expected to worsen after administration of study drugs may be enrolled after consultation with the medical monitor. Subjects with long-term radiotherapy-induced toxicity (judged by the investigator as irreversible) may be enrolled after consultation with the medical monitor.\n16. Pregnancy, lactation, or plans to breastfeed during the study.\n17. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n18. Receipt of live virus vaccines or attenuated live vaccines within 30 days before randomization, or planned vaccination during the study (Note: Inactivated vaccines are permitted).\n19. Known history of mental illness, alcoholism, drug addiction, or substance abuse.\n20. Past or current presence of uncontrolled metabolic disorders, non-tumor-related local\u002Fsystemic diseases, tumor-induced diseases or symptoms (e.g., cachectic manifestations: weight loss \\> 10% within 3 months before screening), laboratory abnormalities, or any treatment that may pose a high medical risk, confound study results, interfere with the subject's full participation in the study, or make study participation not in the subject's best interest.\n21. Subjects deemed unsuitable for study participation by the investigator for other reasons.","75 Years",{"count":51,"type":21},500,[53],"PHASE3","This study is a randomized, controlled, double-blind, multicenter Phase III registration clinical trial, aiming to evaluate the efficacy and safety of HB0025 combined with chemotherapy (pemetrexed plus carboplatin\u002Fcisplatin) versus tislelizumab combined with chemotherapy (pemetrexed plus carboplatin\u002Fcisplatin) as a first-line treatment for unresectable locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) nonsquamous non-small cell lung cancer (NSCLC).\n\nThe study will take progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) as the primary endpoint, and plans to enroll approximately 500 subjects. After being eligible for screening, patients will be randomly assigned to the study groups at a ratio of 1:1 to receive either HB0025 combined with chemotherapy (experimental group) or tislelizumab combined with chemotherapy (control group). Both regimens will be administered once every 3 weeks (Q3W). After completing 4 cycles of treatment, patients will enter the maintenance therapy phase with HB0025 or tislelizumab plus pemetrexed (Q3W). The treatment will last until the investigator determines that there is no longer clinical benefit (based on comprehensive assessment of RECIST v1.1 imaging results and clinical symptoms), intolerable toxicity occurs, 35 cycles of study treatment are completed, or other treatment termination criteria specified in the protocol are met, whichever comes first.",[56],"Non Squamous Non-small Cell Lung Cancer",[58,59,60],"HB0025","Fist Line treatment","nonsq NSCLC","2026-02-01",{"date":63,"type":33},"2026-02-03",{"date":65,"type":21},"2026-01-15",{"date":67,"type":21},"2028-04-10",{"name":39,"class":40},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":41},"100620631","phase-3-phase-iii-clinical-study-of-hb0025-combined-with-chemotherapy-versus-pembrolizumab-combined-with-chemotherapy-for-the-first-line-treatment-of-advanced-squamous-non-small-cell-lung-cancer-100620631","NCT07360132","Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer","A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Able to fully understand and voluntarily sign the informed consent form, and willing and able to comply with the clinical study procedures and follow-up visits.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n3. Expected survival ≥ 12 weeks.\n4. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control \\[UICC\\] and the American Joint Committee on Cancer \\[AJCC\\]) that is inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy or immunotherapy as consolidation treatment.\n\nNote: For subjects with locally advanced (Stage IIIB\u002FIIIC) NSCLC who are inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy or immunotherapy as consolidation treatment, an assessment by relevant specialist physicians and provision of written documentation are required for confirmation.\n\n6\\. No previous systemic anti-tumor treatment for locally advanced or metastatic squamous NSCLC \\[For subjects who have received adjuvant\u002Fneoadjuvant therapy for the purpose of cure for non-metastatic disease or radical concurrent\u002Fsequential chemoradiotherapy for locally advanced disease (including subjects receiving PD-1\u002FL1 inhibitors), If disease progression occurs more than 12 months after the end of the last treatment, one is eligible to participate in this study.\n\n7\\. Subjects must provide tumor tissue samples (archived or freshly obtained) collected at or after the diagnosis of locally advanced or metastatic tumor for central laboratory testing of PD-L1 expression.\n\nNote:The following samples are not accepted: fine-needle aspiration samples (without intact tissue structure, only cell suspensions or smears), brush cytology samples, cell smears from centrifuged pleural effusion drainage, bronchoalveolar lavage fluid samples, and bone lesions without soft tissue components or decalcified bone tumor samples.\n\n8\\. No sensitive EGFR mutations or ALK gene rearrangements. Prior tissue-based test reports for EGFR and ALK status must be provided. If the test reports do not meet the study requirements or are unavailable, tumor tissue samples must be provided for assessment of EGFR and ALK status (tested by a local laboratory recognized by the study site or the central laboratory) before enrollment.\n\nNote: For subjects with squamous NSCLC (excluding mixed-type NSCLC, e.g., adenosquamous carcinoma) who have a smoking history or are current smokers, if the prior EGFR and ALK status is unknown, testing for these markers is not required before enrollment, and they will be deemed negative.\n\n9\\. At least one measurable (non-brain metastatic) lesion per RECIST v1.1 criteria, which is suitable for repeated and accurate measurement. Tumor lesions previously treated with radiotherapy or other local therapies cannot be designated as target lesions, unless:\n\n* The lesion is the only measurable lesion, and the investigator can provide imaging evidence (before and after local treatment) confirming clear disease progression of the lesion after local treatment;\n* The lesion used for fresh tissue biopsy is the only measurable lesion. 10. Confirmed adequate organ function, as evidenced by meeting the following laboratory parameters: 1) Hematology (no receipt of blood component transfusion or hematopoietic growth factor support within 14 days before screening tests):\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n  2. Platelet Count (PLT) ≥ 100 × 10⁹\u002FL;\n  3. Hemoglobin (HGB) ≥ 90 g\u002FL; 2) Renal function:\n\n  a) Serum Creatinine (Scr) ≤ 1.5 × Upper Limit of Normal (ULN), and Creatinine Clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); b) Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein excretion must be \\\u003C 1 g; 3) Hepatic function:\n  1. Serum Total Bilirubin (TBiL) ≤ 1.5 × ULN;\n  2. Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastasis, ALT and AST ≤ 5 × ULN;\n  3. Serum Albumin (ALB) ≥ 30 g\u002FL; 4) Coagulation function: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator must confirm that INR, APTT, and PT are within the safe and effective therapeutic range); 5) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% 11. The toxicity of previous treatment has been restored to grade 0 or 1 of NCI CTCAE version 5.0, or the level specified in the inclusion\u002Fexclusion criteria (except for alopecia). Note: For subjects who experience irreversible toxicity and whose condition is not expected to worsen after administration of the study drug (such as those with hearing loss), they may be included in the study after consultation with medical monitors.\n\n     12\\. Female and male subjects of childbearing potential must agree to use effective contraceptive measures from the screening period until 90 days after the last dose of study treatment. Discussion with the investigator is required to determine whether contraception can be discontinued after this period. Female subjects must not be breastfeeding. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days before randomization.\n\n     Exclusion Criteria:\n     1. Histologically confirmed presence of any small cell carcinoma, neuroendocrine carcinoma, or sarcoma components \\[mixed-type NSCLC (e.g., adenosquamous carcinoma) is permitted for enrollment\\].\n     2. Known presence of driver gene alterations with approved first-line therapeutic options, such as sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.\n     3. History of a second primary malignancy within 3 years before Randomization (enrollment is permitted for other malignancies cured by local treatment, e.g., carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, \\\u003C T1 urothelial carcinoma, and papillary microcarcinoma of the thyroid).\n     4. Symptomatic central nervous system (CNS) metastasis; or diameter of brain metastases ≤ 1.5 cm, or receipt of CNS radiotherapy within 2 weeks before randomization; or anticipated need for CNS radiotherapy during the first treatment cycle after randomization. Subjects with asymptomatic CNS metastasis or symptomatically stable CNS metastasis (≥ 2 weeks before randomization) are permitted for enrollment only if all the following criteria are met:\n\n        * No increase in lesion size or new lesions after treatment; ② No history of intracranial hemorrhage;\n\n          * Discontinuation of corticosteroid therapy \\> 3 days before randomization;\n\n            * Diameter of brain metastases \\\u003C 1.5 cm.\n     5. Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1\u002FL2, anti-CTLA-4 agents), immune checkpoint agonists (e.g., ICOS, CD40, GITR, OX40, CD137 agents), or cellular immunotherapy, or any treatment targeting the tumor immune mechanism. Additionally, for subjects who received PD-(L)1 inhibitors in the neoadjuvant\u002Fadjuvant setting or as consolidation therapy after definitive chemoradiotherapy, enrollment may be permitted (with sponsor approval) if disease progression occurs \\> 12 months after the last dose of prior treatment.\n     6. Prior receipt of systemic anti-angiogenic therapy, including but not limited to bevacizumab and its biosimilars, Endostar, small-molecule TKIs, and ramucirumab.\n     7. Prior antineoplastic treatment or concomitant medication use (washout period calculated from the end of the last treatment):\n\n  \u003C!-- -->\n\n  1. Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional clinical trial or the follow-up phase of an interventional clinical trial (defined as an interval of ≥ 4 weeks between the last dose of the previous study drug and randomization in this study);\n  2. Receipt of chest radiotherapy with \\> 30 Gy within 180 days before randomization; non-chest radiotherapy with \\> 30 Gy within 4 weeks before randomization; local palliative radiotherapy with ≤ 30 Gy for non-target lesions within 2 weeks before randomization;\n  3. Use of Chinese herbal medicines (with antineoplastic indications) within 1 week before randomization; receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, excluding IL-11 for thrombocytopenia treatment) within 2 weeks before randomization;\n  4. Need for systemic use of corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) or other immunomodulators within 2 weeks before randomization \\[short-term use (≤ 7 days) for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction to allergens), or topical use (e.g., intraocular, intra-articular, intranasal, or inhaled administration) is permitted\\].\n  5. Subjects who are currently using preventive or full-dose anticoagulants or antiplatelet drugs for therapeutic purposes and have not reached a stable state before randomization will not be enrolled. According to the medical standards of the enrolling institution, as long as the INR, PT and APTT of the subjects are within the therapeutic range and they have used or are currently using anticoagulants or antiplatelet drugs, they can be enrolled.\n\n     8\\. Major surgery or severe trauma within 4 weeks before the first dose of study treatment; inadequate recovery from prior surgery (as judged by the investigator); anticipated need for major surgery during the study; minor local surgery (e.g., needle biopsy, endoscopy, interventional procedure\u002Fexamination, excluding vascular access establishment) within 7 days before randomization; presence of incompletely healed surgical incisions or wounds.\n\n     9\\. Active autoimmune disease requiring systemic treatment (e.g., treatment with immunomodulators or corticosteroids) within 2 years before randomization, except for replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).\n\n     10\\. Presence of any of the following infections:\n\n  \u003C!-- -->\n\n  1. Severe infection (including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia) within 4 weeks before the first dose of study treatment; active infection requiring systemic anti-infective treatment (with antibiotics for ≥ 7 days) within 2 weeks before randomization;\n  2. Known active tuberculosis (TB) (subjects with suspected active TB must undergo clinical examination to rule out the diagnosis);\n  3. Known active syphilis infection;\n  4. Has a known history of HIV;\n  5. Active hepatitis B or hepatitis C; asymptomatic hepatitis B virus (HBV) carriers (HBV DNA ≤ 200 IU\u002Fml or ≤ 1000 copies\u002Fml or below the lower limit of detection, whichever is applicable) or subjects with clinically cured hepatitis C (HCV RNA below the lower limit of detection) are permitted for enrollment.\n\n     Note: Anti-HBV treatment is required for HBsAg-positive subjects during the study treatment period.\n\n     11\\. Known hypersensitivity to protein drugs, recombinant proteins, components of HB0025, and\u002For components of chemotherapy drugs (pemetrexed and carboplatin\u002Fcisplatin).\n\n     12\\. Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n\n     13\\. Those with a history of non-infectious pneumonia requiring systemic corticosteroid treatment in the past, or currently having interstitial lung disease, pneumoconiosis, drug\u002Fradiation-related pneumonia that requires treatment, or those with severe functional impairment indicated by pulmonary function tests.\n\n     14\\. Presence of any of the following severe comorbidities:\n\n  \u003C!-- -->\n\n  1. Clinically significant bleeding (including but not limited to hemoptysis \\[defined as coughing up or expectorating ≥ 1 teaspoon (approximately 5 ml) of fresh blood or small blood clots, or hemoptysis without sputum; subjects with blood-tinged sputum or transient hemoptysis related to diagnostic bronchoscopy or lung biopsy are permitted\\], gastrointestinal bleeding, nasal bleeding \\[subjects with bloody nasal discharge are permitted\\]) within 4 weeks before the first dose of study treatment; any arterial thrombosis or embolism event, or significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 180 days before the first dose of study treatment; history of deep vein thrombosis within 90 days before the first dose of study treatment;\n  2. Imaging findings at screening showing: Tumor invasion of large blood vessels (e.g., central pulmonary artery, central pulmonary vein, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava); tumor invasion of vital organs (e.g., heart, trachea, esophagus, main bronchus); or imaging evidence of risk for esophagotracheal fistula or esophagopleural fistula; tumor encasement of large blood vessels with vascular stenosis; or pulmonary lesions with obvious necrosis\u002Fcavitation (as judged by the investigator to pose a bleeding risk if enrolled);\n  3. History of persistent bleeding disorders or coagulation disorders (past or current);\n  4. Clinically significant (e.g., active) cardiovascular or cerebrovascular disease within 180 days before the first dose of study treatment, including but not limited to unstable angina requiring hospitalization, myocardial infarction, myocarditis, cardiomyopathy, New York Heart Association (NYHA) Class ≥ II congestive heart failure, poorly controlled severe arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or vascular disease (e.g., aortic aneurysm at risk of rupture); or other cardiac impairment that may affect the safety evaluation of study drugs (e.g., poorly controlled arrhythmia, myocardial ischemia); Fridericia-corrected QT interval (QTcF) \\> 480 ms at screening, or history of congenital long QT syndrome or family history of the syndrome;\n  5. History of conditions potentially causing gastrointestinal bleeding or perforation (e.g., gastrointestinal obstruction, acute Crohn's disease, ulcerative colitis, esophagogastric varices, gastrointestinal perforation, unhealed wound, intra-abdominal abscess, or acute gastrointestinal bleeding) within 180 days before the first dose of study treatment; subjects with chronic Crohn's disease or ulcerative colitis (excluding those who have undergone total colectomy and proctectomy) are excluded, even if in remission;\n  6. History of gastrointestinal fistula or genitourinary fistula (past or current) that remains unhealed after surgical treatment;\n  7. Hydronephrosis unrelieved by nephrostomy or ureteral stenting, or infected hydronephrosis\u002Fhydroureter;\n  8. Current presence of third-space fluid collections (e.g., pleural effusion, pericardial effusion, abdominal\u002Fpelvic effusion) requiring repeated puncture\u002Fdrainage for local management; or receipt of local drainage within 2 weeks before the first dose of study treatment;\n  9. Acute exacerbation of chronic obstructive pulmonary disease within 30 days before the first dose of study treatment;\n  10. Current presence of uncontrolled comorbidities, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis (enrollment decision requires joint discussion between the investigator and the sponsor).\n\n      15\\. Pregnant or lactating women, or those planning to breastfeed during the study period.\n\n      16\\. There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n      17\\. Live virus vaccine or attenuated live vaccine was received within 30 days before randomization, or vaccination was planned during the study period (Note: Inactivated vaccine is allowed).\n\n      18\\. It is known that there is a history of mental illness, alcoholism, drug abuse or substance abuse.\n\n      19\\. There have been or are currently uncontrolled metabolic disorders, local or systemic diseases not caused by tumors, secondary diseases or symptoms of tumors, abnormal laboratory tests or any treatments that may lead to higher medical risks and\u002For confuse research results, interfere with the subjects' participation in the entire study, or participation in the study may not be in the best interests of the subjects.\n\n      20\\. Subjects who, as assessed by the researchers, are not suitable to participate in the trial for other reasons.",{"count":77,"type":21},480,[53],"This study is a randomized, controlled, double-blind, multi-center phase III registration clinical trial, aiming to observe, compare and evaluate the efficacy and safety of HB0025 combined with paclitaxel + carboplatin compared with pembrolizumab combined with paclitaxel + carboplatin as the first-line treatment for locally advanced or metastatic squamous NSCLC.\n\nThe study subjects are patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received systemic anti-tumor treatment before. The study will use the PFS evaluated by BICR as the primary endpoint, and plan to enroll approximately 480 subjects, with the proportion of locally advanced subjects not exceeding 10%.\n\nThe subjects were fully informed and signed the informed consent form. If they met the inclusion criteria but did not meet the exclusion criteria, they were randomly assigned in a 1:1 ratio to receive HB0025 combined with chemotherapy Paclitaxel plus Platinum (experimental group) or pembrolizumab combined with chemotherapy Paclitaxel plus Platinum (control group). Both were administered once every 3 weeks (Q3W). After 4 cycles of treatment, Enter HB0025 or pembrolizumab monotherapy maintenance treatment (Q3W) until the investigator determines that there is no longer any clinical benefit (based on the RECIST v1.1 imaging assessment and comprehensive clinical symptom assessment by the investigator), intolerable toxicity occurs, 24 months of study treatment is completed, or other treatment termination criteria in the protocol are met. Whichever occurs first shall prevail.",[81],"Squamous Non-small Cell Lung Cancer",[58,83,84],"sq-NSCLC","Fiest Line treatment","2026-01-13",{"date":87,"type":33},"2026-01-22",{"date":65,"type":21},{"date":90,"type":21},"2028-08-10",{"name":39,"class":40},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":41},"100584910","phase-1-efficacy-safety-and-tolerability-of-hb0043-in-hidradenitis-suppurativa-patients-100584910","NCT06895499","Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.","A Phase I\u002FII, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS).","HB0043-HS-0-01","Inclusion Criteria:\n\n* 1\\. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosis of HS with a disease duration of at least 6 months before screening; 4. Moderate to severe HS, concurrently meeting the following three criteria:\n\n  1. HS lesions in at least 2 distinct anatomic area;\n  2. One of the HS lesions must be Hurley Stage II or Hurley Stage III;\n  3. Total abscess and inflammatory nodule (AN) count of greater than or equal to 3; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.\n\nExclusion Criteria:\n\n* 1\\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Participant has a draining fistula count of ≥20 at the Screening Visit; 3. Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 4. Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 6. History of recurrent or recent serious infection; 7. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 8. Pregnant or lactating women; 9. Any reason why, in the opinion of the investigator, the patient should not participate.",{"count":101,"type":21},15,[24,25],"The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.",[105],"Hidradenitis Suppurativa","RECRUITING","2026-01-04",{"date":109,"type":33},"2026-01-07",{"date":111,"type":33},"2025-03-19",{"date":113,"type":21},"2026-03-30",{"name":39,"class":40},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":41},"100563192","phase-1-a-study-to-evaluate-single-dose-of-hb0056-in-healthy-adult-participants-100563192","NCT06612970","A Study to Evaluate Single-dose of HB0056 in Healthy Adult Participants","A Phase 1a, Randomized, Double-blind, Placebo-controlled, Single Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HB0056 in Adult Healthy Subjects.","Inclusion Criteria:\n\n* Healthy male or female subjects age ≥ 18 and ≤ 55 years.\n* Body Mass Index (BMI) ≥ 18 and ≤ 32 kg\u002Fm².\n* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.\n* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.\n\nExclusion Criteria:\n\n* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.\n* Current or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)\n* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).\n* Pregnant or Breasting feeding subject. Women with a positive pregnancy test .\n* Further exclusions criteria applied.","55 Years",{"count":124,"type":21},46,[24],"The aim of this study is to investigate the safety and tolerability of HB0056 in healthy subjects following single-dose.",[128],"Healthy",[130],"HB0056","2025-09-05",{"date":133,"type":33},"2025-09-08",{"date":135,"type":33},"2024-11-18",{"date":137,"type":21},"2025-10-01",{"name":39,"class":40},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100533865","phase-2-efficacy-and-safety-of-hb0034-in-patients-with-generalized-pustular-psoriasis-gpp-100533865","NCT06231381","Efficacy and Safety of HB0034 in Patients with Generalized Pustular Psoriasis (GPP)","A Phase II, Multicenter, Double-blind, Randomized, Placebo Parallel-controlled Trial to Evaluate the Efficacy and Safety of HB0034 in Patients with GPP Presenting with an Acute Flare of Moderate to Severe Intensity","Inclusion Criteria:\n\n* Patients must be experiencing an acute GPP flare of moderate-to-severe intensity at baseline, defined as:\n\n  1. A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of ≥ 3;\n  2. New appearance or worsening of existing pustules, and a GPPGA pustulation subscore of ≥ 2;\n  3. ≥ 5% Body Surface Area (BSA) covered with pustules.\n* Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;\n* Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules.\n\nExclusion Criteria:\n\n* Drug-triggered acute generalized exanthematous pustulosis (AGEP);\n* Synovitis-acne-pustulosis-hyperostosis-osteitis syndrome (SAPHO);\n* Other active inflammatory or autoimmune diseases requiring systemic treatment with immunosuppressants, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), systemic lupus erythematosus (SLE), inflammatory bowel disease, and uveitis.\n* Patients with an increased risk of infectious complications as assessed by the investigator (e.g., a recent suppurative infection, any congenital or acquired immunodeficiency, such as HIV infection, prior organ or stem cell transplantation);\n* Patients who have received a live vaccine or investigational live vaccine within 6 weeks prior to the first dose of the study drug, or plan to receive a live vaccine or participate in a clinical study of investigational live vaccine during the study period or within 6 weeks after completion of administration of the study drug;\n* Patients who have had a serious trauma or undergone a major surgery within 1 month prior to the first dose of the study drug, or plan to undergo any elective surgery during the study period;\n* Patients with documented active or suspected malignancy or a history of malignancy within 5 years prior to screening;\n* Patients with a history of severe allergy, who have experienced grade 3-4 allergic reactions when receiving other monoclonal antibodies, or those who are known to have hypersensitivity to protein drugs, recombinant proteins, or HB0034 components;\n* Subjects who are pregnant or breastfeeding, or those who have a positive pregnancy test result. Breastfeeding female subjects who stop breastfeeding prior to the first dose of the study drug until 16 weeks after the end of the trial will not be excluded;\n* Patients who are currently participating in clinical trials or have participated in clinical trials of any drug\u002Fdevice within 30 days (or 5 half-lives, whichever is longer) prior to the first dose of the study drug;\n* Patients expected to have poor compliance, such as those who are uncooperative, fail to receive follow-up on time, and are unlikely to complete the study;\n* Other reasons that the investigator considers it is inappropriate to participate in the study.",{"count":147,"type":21},33,[25],"This is a phase II, multicenter, double-blind, randomized, placebo parallel-controlled clinical trial to evaluate the efficacy and safety of HB0034 in patients with generalized pustular psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.",[151],"Generalized Pustular Psoriasis (GPP)","2025-03-18",{"date":111,"type":33},{"date":155,"type":33},"2024-02-29",{"date":157,"type":21},"2025-11-30",{"name":39,"class":40},2,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100552780","phase-2-long-term-safety-and-efficacy-of-hb0034-in-subjects-with-generalized-pustular-psoriasis-100552780","NCT06477536","Long-Term Safety and Efficacy of HB0034 in Subjects With Generalized Pustular Psoriasis","A Phase IIb, Long-Term Extension Study to Evaluate the Safety and Efficacy of HB0034 in the Treatment of Adult Subjects With Generalized Pustular Psoriasis","Inclusion Criteria:\n\n* Patients participated in the preceding placebo-controlled Phase 2 study （HB0034-04）and completed at least the Week 12 visit of the HB0034-04 study\n* Subject must be a candidate for prolonged GPP treatment according to the Investigator's judgment\n* Men and women of reproductive age who have no parenting plans and are willing to use reliable contraception during the study period and for 6 months after the last dose of the study drug;\n* Patients who fully understand and voluntarily sign an ICF, and are willing and able to follow clinical study and subsequent visit schedules\n\nExclusion Criteria:\n\n* Patients who are experiencing GPP flare",{"count":147,"type":21},[25,53],"This is a Phase IIb, long term extension study to evaluate the safety and efficacy of HB0034 in adult subjects with generalized pustular psoriasis (GPP).",[171],"Generalized Pustular Psoriasis","2025-02-12",{"date":174,"type":33},"2025-02-14",{"date":176,"type":33},"2024-09-02",{"date":178,"type":21},"2026-06-30",{"name":39,"class":40},3,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":41},"100571123","phase-1-a-study-to-evaluate-hb0034-in-healthy-chinese-adult-participants-100571123","NCT06716151","A Study to Evaluate HB0034 in Healthy Chinese Adult Participants","A Phase I, Randomized, Double-blind, Placebo-controlled, Single\u002Fmulit Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HB0034 in Adult Healthy Subjects","Inclusion Criteria:\n\n* Healthy male or female subjects age ≥ 18 and ≤ 55 years.\n* Body Mass Index (BMI) ≥ 17.5 and ≤ 32 kg\u002Fm².\n* Normal ECG, blood pressure, respiratory rate, temperature, and heart rate, unless the investigator considers any abnormality to be not clinically significant.\n\nSigned and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.\n\nExclusion Criteria:\n\n\\- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.\n\nCurrent or history of malignancy. • Family history of premature Coronary Heart Disease (CHD)\n\n* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).\n* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.\n* Further exclusion criterias apply.","45 Years",{"count":190,"type":21},60,[24],"The aim of this study is to investigate the safety and tolerability of HB0034 in healthy subjects following a single dose or multiple dose.",[128],[195],"Healthy subjects","2025-01-16",{"date":198,"type":33},"2025-01-20",{"date":200,"type":33},"2024-12-06",{"date":202,"type":21},"2025-11-20",{"name":39,"class":40},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100471318","phase-1-a-study-evaluating-the-safety-and-efficacy-of-hb0036-in-subjects-with-advanced-solid-tumors-100471318","NCT05417321","A Study Evaluating the Safety and Efficacy of HB0036 in Subjects With Advanced Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects With Advanced Solid Tumors","Inclusion Criteria\n\nPatients must meet all the following criteria to be eligible for participation in this study:\n\n1. Male or female. Age ≥ 18 years;\n2. Phase I: Patients with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors (or clinically diagnosed hepatocellular carcinoma) that failed all standard therapies known to provide clinical benefit; \\[These solid tumors include but not limit to: non-small cell lung cancer, esophageal squamous cell carcinoma, melanoma, head and neck squamous cell carcinomas, hepatocellular carcinoma, gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, etc.\\];\n3. Phase II: Histologically or cytologically documented locally advanced, recurrent or metastatic cancer. There will be several tumor-specific cohorts Advanced non-small cell lung cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic NSCLC; Confirmed availability of representative tumor specimens in formalin-fixed paraffin-embedded (FFPE）blocks or at least 5 stained serial slides or fresh biopsied specimens (preferred),samples obtained before adjuvant \u002F neoadjuvant chemotherapy are allowed only if biopsy cannot be performed; Tumor PD-L1 expression with a TPS≥1 %; Negative for actionable molecular markers \\[including but not limited to: epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) gene fusion mutation, etc.\\]； Assessed by the investigator as likely to benefit from the study drug therapy; and should have progressed at least one prior systemic therapy regimen.\n\n   Advanced other cancer cohort Histologically or cytologically documented locally advanced, recurrent or metastatic cancer (esophageal squamous cell carcinoma, melanoma) Other tumor histologies will be evaluated pending data from the dose escalation phase that may inform on possible efficacy in select tumors\n4. At least one measurable lesion( assessable lesion only accepted during accelerated titration stage) as per RECIST v. 1.1 defined as non-nodal lesions having at least one dimension with a minimum size of 10 mm in the longest diameter by CT or MRI scan or ≥15 mm in short axis for nodal lesions. Radiographic disease assessment at baseline can be performed up to 21 days prior to the first dose.\n\n   Note: Tumour lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n6. Life expectancy ≥12 weeks\n7. Adequate organ function within 14 days of the first dose as defined by the following criteria:\n\n   a) Hematology\n   * absolute neutrophil count (ANC) ≥ 1.5×109\u002FL;\n\n     ② platelets (PLT) ≥ 75×109\u002FL;\n\n     ③ hemoglobin (HGB) ≥ 90 g\u002FL; Note: The above three items require that patients should not have received any blood component or cell growth factor supportive therapy within two weeks prior to blood sampling.\n\n     b) Renal function: Calculated creatinine clearance (CrCL) \\> 50 mL\u002Fmin (Cockroft-Gault Equation); c) Liver function:\n   * AST and ALT ≤ 2.5×ULN; AST or ALT ≤5×ULN if liver metastases are present;\n\n     ② Total bilirubin (TBIL) ≤ 1.5×ULN; ≤3 X ULN for patients with Gilbert's disease; d) Coagulation function:\n   * International normalized ratio (INR)or prothrombin time (PT)≤ 1.5×ULN (unless patient on oral anticoagulant with stable dose); ② Activated partial thromboplastin time (APTT)≤ 1.5×ULN;\n8. Women of childbearing potential must confirm a negative serum or urine pregnancy test within 3 days prior to the initiation of study treatment; Fertile patients and their partners must agree to use effective contraceptives for the duration of study drug use and for 90 days after the last administration of study treatment\n9. Recovery to Grade 0-1 from adverse events (AEs) related to prior anticancer therapy except alopecia, \\\u003C Grade 2 sensory neuropathy, and endocrinopathies controlled with hormone replacement therapy\n10. The subject is able to understand and willing to sign the ICF; willing and able to comply with all study procedures.\n\nExclusion Criteria\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Concurrent malignancy \\\u003C 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or \\\u003C T1 urothelial carcinoma. Patients with prostate cancer that is under active surveillance are eligible.\n2. Phase I: Patients may have received single agent treatments targeting the TIGIT pathway.\n\n   Phase II: Have received previous simultaneous therapy with a PD-1 pathway inhibitor and a TIGIT inhibitor; previous monotherapy with TIGIT\u002FPD-1\u002FPD-L1 inhibitor is allowed.\n3. Have received antibiotics lasting over 1 week within 28 days prior to first dose;\n4. Have clinically active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic. Patients with asymptomatic brain metastasis or subjects who are symptomatically stable after treatment and are on \\\u003C 10 mg\u002Fd prednisone or equivalent are eligible.\n5. Have history of interstitial lung disease or non-infectious pneumonitis (except from radiotherapy);\n6. Active autoimmune disease or history of autoimmune disease requiring systemic therapy \\\u003C 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.\n7. History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for grade 3 endocrinopathy that is managed with hormone replacement therapy).\n8. Use of systemic corticosteroids in a dose equivalent to \\>10 mg\u002Fday of prednisone or other immunosuppressive agent \\\u003C 2 weeks prior to screening; the use of topical, intraocular, intraarticular, intranasal, or inhaled corticosteroids and systemic steroids to prevent (e.g., allergy to contrast agents) or treat non-autoimmune condition (e.g., delayed hypersensitivity caused by exposure to allergens) or short course (\\\u003C 5 days) will be allowed\n9. Anticancer therapy or radiation \\\u003C 5 half-lives or 4 weeks (whichever is shorter) prior to study entry; palliative radiotherapy to a single area \\\u003C 2 weeks prior to study screening is permitted. Measurable lesions cannot be previously irradiated unless they have demonstrated growth after radiation therapy (RT).\n10. Major surgery (except for diagnostic needle biopsy or intravenous catheterization) or chemotherapy\u002F interventional therapy\u002Fradiation therapy\u002Fablation therapy \\\u003C 4 weeks prior to the first dose;\n11. Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure \\\u003C 6 months of study entry; mean ECG QT-interval corrected according to Fridericia's formula (QTcF) \\> 470 milliseconds (ms) obtained from three ECGs; uncontrolled arrhythmia \\\u003C 3 months of study entry. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.\n12. Patients who have previously received allogeneic stem cell or solid organ transplantation.\n13. Have received or will receive a live vaccine within 4 weeks prior to the first dose, except COVID-19 vaccine.\n14. Patients whose existing significant clinical abnormalities or laboratory abnormalities may affect the evaluation of the study drug by the Investigator's judgement, e.g. uncontrolled active infection (\\>Grade 2, CTCAE v5.0), uncontrolled diabetes, poorly controlled hypertension with the combination of the two drugs (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg), congestive heart failure, myocardial infarction within 24 weeks, etc.;.\n15. Positive results for HIV test.\n16. Active hepatitis B or C. Patients with asymptomatic hepatitis B virus carriers (HBV DNA titer \\\u003C 1000 CPS \u002FmL or 200 IU\u002FmL) or cured hepatitis C (negative HCV RNA test) may be enrolled;\n17. Positive COVID-19 qRT-PCR or rapid screening test during screening; can be eligible after quarantine (14 days) if COVID-19 test becomes negative.\n18. Patients with active tuberculosis (TB) who are receiving anti-TB treatment or who received anti-TB treatment within 1 year prior to screening;\n19. Women who are pregnant or lactating, or women of childbearing potential who do not wish to use effective contraception method during the trial.\n20. Men with a partner of childbearing potential who do not consent to use acceptable methods of birth control during treatment and for an additional 90 days after the last administration of study drug.\n21. History of severe allergic reactions, grade 3-4 allergic reactions to treatment with another monoclonal antibody, or known to be allergic to protein drugs or recombinant proteins or excipients in HB0036 drug formulation;\n22. Patients who have participated in any clinical trial of a drug or medical device within 4 weeks prior to the first dose.\n23. Abuse of alcohol, cannabis- derived products or other drugs; can be eligible with remote history of abuse more than 2 years.\n24. Any other serious underlying medical condition (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), or psychiatric, psychological, familial condition or geographical location that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment.\n25. Other conditions which would make it inappropriate for the patient to participate as judged by the investigator.",{"count":212,"type":21},80,[24,25],"It is a Phase I\u002FII, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HB0036 in Subjects with Advanced Solid Tumors",[216,217],"Advanced Solid Tumor","NSCLC","2025-01-02",{"date":220,"type":33},"2025-01-03",{"date":222,"type":33},"2022-08-25",{"date":224,"type":21},"2025-08-01",{"name":39,"class":40},4,""]