[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumor-malignancies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumor-malignancies":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,69,92],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587354","phase-1-phase-i-study-of-the-safety-tolerability-and-efficacy-of-an-engineered-mitochondrial-vaccine-in-advanced-solid-tumors-100587354",false,"NCT06927297","Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors","A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of an Engineered Mitochondrial Vaccine in Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years at the time of acquisition informed consent form.\n2. Patients with advanced malignant solid tumors such as non-small cell lung cancer or colorectal cancer, confirmed by histology or cytology, who are unable to receive or tolerate standard treatments, or who refuse standard treatments, exhibit positive expression of target antigens in the tumor tissue.\n3. The presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2.\n5. Predicted survival time ≥3 months.\n6. The main organs are functioning well and the following requirements are met within 7 days before receiving treatment:\n\n   ① Hemoglobin (HGB) ≥80 g\u002FL (no blood transfusion within 14 days); Absolute neutrophil count (ANC) \\>1.5×109\u002FL; White blood cell count ≥3.0×109\u002FL; Platelet count (PLT) ≥80×109\u002FL;\n\n   ② Total bilirubin ≤1.5× upper limit of normal value (ULN); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; If there was liver metastasis, ALT or AST≤5×ULN;\n\n   ③ Creatinine (SCr) ≤1.5×ULN or creatinine clearance (CRCI) estimated by Cockcroft-Gault formula ≥60 mL\u002Fmin;\n\n   ④ Prothrombin time (PT), international normalized ratio (INR) ≤1.5×ULN (unless anticoagulation with warfarin);\n\n   ⑤ Cardiac function: left ventricular ejection fraction ≥50%. QTcF interval ≤450 ms.\n7. Men of childbearing potential and women of childbearing age voluntarily use effective contraceptive methods (e.g., condoms, intrauterine devices, spermicides) from the time of signing the informed form until 6 months after the completion of vaccination, and contraceptive use is not allowed. Female cancer patients who have a negative pregnancy test and agree not to breastfeed during the study and for at least 18 months after receipt of the trial vaccine;\n8. The washout period of previous anti-tumor therapy should be at least 4 weeks, and the washout period of molecular targeted drugs should be at least 5 half-lives. Palliative radiotherapy needs to have been completed for at least 2 weeks; Chest radiation therapy needed to have been completed for at least 3 months, and major surgery needed to have been completed with at least 4 weeks of recovery.\n\nExclusion Criteria:\n\n1. The patient has a history of other tumors in the past, except for the history of malignant tumors that have been cured and have not recurred within 5 years before screening, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical cancer in situ, and intramucosal cancer of the gastrointestinal tract, which the investigator considers to be eligible for enrollment.\n2. Have any uncontrolled clinical diseases (e.g., diseases of the respiratory system, circulatory system, digestive system, nervous system, hematologic system, urogenital system, endocrine system) or psychiatric or other major medical condition that the investigator considers to interfere with the provision of informed consent, to interfere with the interpretation of the trial results, to pose a risk to the study participants, or to otherwise interfere with the achievement of the study objectives.\n3. Have any active autoimmune disease or a history of autoimmune disease. Participants with asthma for which medical intervention with bronchodilators was required could not be included.\n4. Allergy to the trial drug (including any excipients). Previous history of severe allergy to any drug, food or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.\n5. There are contraindications to subcutaneous injection.\n6. Received prior antitumor therapeutic vaccine or cellular immunotherapy.\n7. Participated in other drug or device clinical trials 4 weeks before screening.\n8. Study participants on systemic therapy with corticosteroids (\\>10 mg\u002F day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of vaccine. Inhaled or topical steroids and adrenal hormone replacement at a therapeutic dose of prednisone of 10 mg or less per day were allowed in the absence of active autoimmune disease.\n9. Before the first dose of the study drug. Any toxic effects from previous antineoplastic therapy have not recovered to NCI CTCAE grade 5.0 ≤1 (any degree of alopecia, other than grade 2 previous platinum-based treatment-related neuropathy).\n10. Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n11. Have a history of substance abuse or known medical, psychological, or social conditions such as alcohol or drug abuse.\n12. Have received any vaccine within 30 days before receiving the study vaccine or plan to receive any vaccine other than the study vaccine during the study.\n13. The presence of any other factor that was deemed by the investigator to preclude study participant entry into the trial or that study participant had any medical condition that could interfere with the assessment of the safety or efficacy of the study treatment.\n14. Study participants who were unwilling or unable to comply with study requirements.","ALL","18 Years","75 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study is a dose-escalation, prospective clinical trial to assess the safety, tolerability, and preliminary therapeutic efficacy of engineered mitochondria expressing specific tumor antigen in patients with advanced solid tumors.",[27,28],"Advanced Solid Tumor Malignancies","Advanced Solid Malignancies",[30,31,32],"advanced solid tumors","cancer vaccines","engineered mitochondria","RECRUITING","2026-03-15",{"date":36,"type":37},"2026-03-17","ACTUAL",{"date":39,"type":37},"2025-05-09",{"date":41,"type":21},"2028-04-30",{"name":43,"class":44},"West China Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100629506","phase-1-jskn016hc-in-patients-with-advanced-or-metastatic-solid-malignant-tumors-100629506","NCT07475559","JSKN016HC in Patients With Advanced or Metastatic Solid Malignant Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002F Pharmacodynamics, and Anti-tumor Activity of JSKN016HC in Subjects With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Patients who are able to understand the informed consent form (ICF), voluntarily participate, and sign the ICF;\n2. Patients who are ≥18 years of age on the day of signing the informed consent form, male or female;\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1;\n4. Life expectancy ≥ 3 months;\n5. At least one non-cranial measurable lesion at baseline according to RECIST 1.1 criteria. Target lesions must not have received prior local therapy (e.g., radiotherapy), or there must be evidence of disease progression in the lesion after local therapy;\n6. Patients with histologically and\u002For cytologically confirmed advanced unresectable or metastatic epithelial-derived malignant tumors who have failed prior standard of care (disease progression, intolerance, or inaccessibility of standard of case);\n7. Adequate organ function (results from within 7 days before the first dose are required for the following laboratory tests; echocardiogram results from within 28 days before the first dose are acceptable):\n\n   1. Bone marrow function (no whole blood or blood component transfusions within 14 days before the first dose; no use of haematopoietic growth factors within 7 days before the first dose): Absolute neutrophil count ≥1.5×109\u002FL; haemoglobin ≥90 g\u002FL; platelet count ≥100×109\u002FL;\n   2. Liver function (based on the normal values of each clinical study site): Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3×ULN (≤ 5×ULN for subjects with metastases to liver); albumin ≥ 28 g\u002FL;\n   3. Renal function: Blood creatinine ≤ 1.5 ×ULN, or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin as calculated by the Cockcroft-Gault formula; urine protein ≤ 1+ or 24-hour (h) quantitative urine protein \\\u003C 1.0 g;\n   4. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n   5. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% (by echocardiogram);\n8. Female patients of childbearing potential or male patients with partners of childbearing potential must agree to use highly effective contraception from the time of signing the ICF until 24 weeks after the last dose. Female patients of childbearing potential must have a negative serum\u002Furine pregnancy test within 7 days before the first dose;\n9. Patients who are able and willing to comply with the visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Presence of metastasis to brainstem, metastasis to meninges, metastasis to spinal cord or compression, or a history of carcinomatous meningitis; presence of active brain metastasis. Note: a. For patients with brain metastasis previously treated with local therapy (e.g., surgery, radiotherapy): patients who are clinically stable for at least 4 weeks before the first dose (imaging examination shows stable lesions, no new neurological symptoms, no evidence of new or enlarging pre-existing brain metastasis), and have not required corticosteroids or anticonvulsants for at least 2 weeks are eligible for enrollment; b. For patients with brain metastasis not previously treated with local therapy: patients with no neurological symptoms related to brain metastasis, not requiring corticosteroid treatment, no significant oedema around brain metastasis, and with all brain metastases \\\u003C 1.5 cm are eligible for enrollment;\n2. Imaging during the screening period shows the tumor invades or compresses the surrounding vital organs (e.g., heart and pericardium, trachea, oesophagus, superior vena cava, etc.) or risk of developing oesophageal-tracheal fistula or oesophageal-pleural fistula;\n3. Insufficient washout period for prior therapies before the first dose:\n\n   1. Receipt of any investigational drug within 28 days before dosing;\n   2. Receipt of other anti-tumor therapy within 28 days before dosing or within 5 half-lives of a prior anti-tumor drug (whichever is shorter, but at least 14 days is required);\n   3. Receipt of Chinese herbal medicines or proprietary Chinese medicines with a clear anti-tumor indication within 14 days before dosing;\n   4. Receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, etc.) within 14 days before the first dose;\n   5. Requirement for continuous treatment with glucocorticoids (\\> 10 mg\u002Fday prednisone, or equivalent dose of other glucocorticoids) or immunosuppressants for 7 days within 14 days before the first dose; excluding inhaled or topical steroids, or physiological replacement doses of steroids for adrenal insufficiency; short-term (≤7 days) use of glucocorticoids for prophylaxis (e.g., for contrast media allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity due to allergen exposure) is permitted;\n   6. Receipt of local palliative therapy within 14 days before dosing;\n   7. Major surgery within 28 days before dosing (e.g., major abdominal or thoracic surgery; minor procedures such as diagnostic aspiration, infusion device implantation, or biliary stent placement are not included), or anticipation of requiring major surgery during the study;\n   8. Receipt of a live vaccine within 30 days before the first dose, or planned receipt of a live vaccine during the study;\n4. Prior treatment with an ADC containing a topoisomerase I inhibitor (e.g., DS-8201, HER3-DXd, DS-1062, etc);\n5. Concurrent other malignant tumor within 5 years before dosing, excluding cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, and in situ prostate\u002Fcervical\u002Fbreast cancer\u002F papillary thyroid carcinoma, etc;\n6. Presence or history of the following lung disorders that cause severe impairment of respiratory function:\n\n   1. Active or severe structural lung disorder: including pulmonary embolism diagnosed within 6 months before the first dose, uncontrolled severe asthma (e.g., requiring continuous systemic steroid therapy or frequent acute exacerbations), severe chronic obstructive pulmonary disease, or severe restrictive pulmonary disease (e.g., severe pulmonary fibrosis, deformity thorax), etc.;\n   2. Systemic diseases with pulmonary involvement: autoimmune diseases, connective tissue diseases, or inflammatory diseases (e.g., rheumatoid arthritis, sicca syndrome, sarcoidosis, etc.) causing significant impairment of respiratory function;\n   3. Pulmonary resection: prior pneumonectomy;\n7. Current interstitial lung disease (ILD) or non-infectious pneumonia (e.g., idiopathic pulmonary fibrosis, radiation pneumonitis, etc.) requiring systemic glucocorticoid or other immunosuppressant therapy;\n8. Clinically significant gastrointestinal abnormalities, including but not limited to:\n\n   1. Intestinal obstruction or signs and symptoms of intestinal obstruction within 6 months before the first dose, but screening is permissible if surgery has been performed and the obstruction is completely resolved (patients who have previously received an intestinal stent that has not been removed by the screening period are not allowed to enroll);\n   2. History of gastrointestinal perforation, intestinal fistula, intra-abdominal abscess, and non-gastrointestinal fistula (e.g., oesophageal-tracheal fistula) within 6 months before the first dose;\n   3. Gastrointestinal haemorrhage of ≥ Grade 3 (CTCAE v5.0) within 6 months before the first dose, or gastrointestinal haemorrhage within 1 month (including melaena, haematochezia, etc.; patients confirmed to have haemorrhoidal haemorrhage or only presenting with faecal occult blood positive are eligible for enrollment);\n9. Active autoimmune disease requiring systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants). Note: Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;\n10. Presence of serous cavity effusion (e.g., pleural effusion, pericardial effusion, ascites) that is clinically symptomatic or requires repeated drainage(\\>1 time\u002Fweek), or has required drainage within 14 days before the first dose;\n11. Presence of any of the following cardiovascular or cerebrovascular disorders or risk factors:\n\n    1. Myocardial infarction, unstable angina, acute or persistent myocardial ischaemia, Grade ≥3 cardiac failure (NYHA classification), symptomatic or poorly controlled severe arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, complete left or right bundle branch block, history of second- or third-degree heart block, etc.), cerebrovascular accident, transient ischaemic attack, or other severe cardiovascular or cerebrovascular disorders within 6 months before the first dose;\n    2. Any arterial thromboembolic event or venous thromboembolic event of ≥ Grade 3 (CTCAE v5.0) within 6 months before the first dose;\n    3. Presence of major vascular diseases that may be life-threatening or require surgery within 6 months, such as aortic aneurysm, aortic dissection, or severe internal carotid artery stenosis;\n    4. Risk of QT interval prolongation or severe arrhythmia, including baseline QT interval corrected by Fridericia's formula (QTcF) \\> 470 ms, refractory hypokalaemia, long QT syndrome, etc.;\n    5. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n    6. Presence of moderate to severe pulmonary arterial hypertension;\n12. Uncontrolled infection, including but not limited to the following:\n\n    1. Active HBV or HCV infection. HBsAg-positive patients are required to undergo HBV-DNA testing; if HBV-DNA is above the lower limit of detection of the local laboratory, they will be excluded. For HBsAg-positive patients, enrollment is permitted if HBV-DNA is below the lower limit of detection after receiving antiviral therapy, and anti-HBV therapy should be continued after subsequent treatment. HCV-Ab-positive patients are eligible for enrollment if HCV-RNA test is negative;\n    2. Severe infection within 4 weeks before the first dose, including but not limited to comorbidities requiring hospitalisation, sepsis, or severe pneumonia; active infection requiring systemic anti-infective drug therapy within 2 weeks before the first dose;\n    3. History of immunodeficiency, positive test for human immunodeficiency virus (HIV), or history of acquired immunodeficiency syndrome (AIDS);\n    4. Known active tuberculosis;\n    5. Active syphilis;\n13. Toxicity from prior anti-tumor therapy has not resolved to ≤ Grade 1 (CTCAE v5.0) or the level specified in the inclusion\u002Fexclusion criteria. Note: Patients with chronic, stable Grade 2 toxicity that the investigator considers related to prior anti-tumor therapy may be enrolled after discussion with the sponsor and medical monitor (defined as stable toxicity severity, CTCAE Grade ≤2, within 3 months before the first dose), such as: chemotherapy-induced neurotoxicity, alopecia, skin hyperpigmentation, fatigue, endocrine toxicity from prior immunotherapy (e.g., thyroid dysfunction, diabetes mellitus, adrenal insufficiency);\n14. History of prior allogeneic bone marrow or organ transplant;\n15. Known hypersensitivity to any component of the investigational product; history of severe allergic reactions to other antibody-based drugs;\n16. History of severe xerophthalmia, severe meibomian gland disease and\u002For blepharitis, keratopathy causing incurable or delayed healing of the subject's cornea, or maculopathy;\n17. Women who are pregnant and\u002For breastfeeding, or who plan to become pregnant during the study;\n18. Known history of psychiatric illness, drug abuse, alcoholism, etc., or other conditions that, in the investigator's opinion, would interfere with the safety or compliance of drug therapy in this study;\n19. Prior or current presence of any other disease, treatment, or abnormal laboratory test that might confound the study results, interfere with the subject's full participation in the study, or for which participation in the study might not be in the subject's best interest;\n20. Presence of local or systemic diseases caused by non-malignant tumor, or diseases or symptoms secondary to the tumor, which may lead to higher medical risk and\u002For uncertainty in survival assessment, such as tumor-related leukaemoid reaction (white blood cell count \\>20×109\u002FL), cachexia, etc.",{"count":54,"type":21},42,[24],"This is a Phase I, open-label, multicenter, first-in-human study to evaluate the safety, tolerability, PK\u002Fpharmacodynamic (PD) characteristics, and anti-tumor activity of JSKN016HC in subjects with advanced malignant solid tumors.",[27],"NOT_YET_RECRUITING","2026-03-11",{"date":61,"type":37},"2026-03-16",{"date":63,"type":21},"2026-03-01",{"date":65,"type":21},"2028-07-01",{"name":67,"class":68},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd","INDUSTRY",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":90,"locationsCount":4},"100604922","lymphocyte-function-testing-in-immuno-oncology-100604922","NCT07155811","Lymphocyte Function Testing in Immuno-oncology","Prospective, Single-center, Clinico-biological Cohort Evaluating the Automated VIDAS STIMM T Test in Patients With Advanced\u002FMetastatic Solid Tumors Treated With Standard Immunotherapy","T-ECHNICO","Inclusion Criteria:\n\n* Male or female aged 18 years or older with a confirmed diagnosis of solid tumors (any type of tumor) in advanced or metastatic stages\n* Patients who are due to start standard treatment with anti-PD1, anti-PDL1, or anti-CTLA4 (combinations of ICIs are permitted) at the Léon Bérard Center:\n\n  * Cohort A: ICI without concomitant chemotherapy\n  * Cohort B: ICI with concomitant chemotherapy\n* Patients who have understood, dated, and signed the consent form for this study before undergoing any protocol-specific procedures.\n* Patients affiliated with or covered by a social security system.\n\nExclusion Criteria:\n\n* Patients to be treated with immunotherapy in combination with targeted therapy.\n* Patients treated with chemotherapy within the last 21 days prior to D1 of immunotherapy\n* Pregnant or breastfeeding patients.\n* Patients with other known cancers that are progressing or requiring the initiation of another treatment.\n* Patients with psychological, family, geographical, or social circumstances that, in the investigator's judgment, could potentially prevent the signing of an informed consent form and\u002For compliance with study procedures.\n* Patients in one or more of the following situations: subject to legal protection measures, deprived of liberty by judicial or administrative decision, receiving psychiatric care, admitted to a health or social care facility for purposes other than research",{"count":78,"type":21},100,[80],"NA","Several studies have shown that the presence and levels of IFN-γ may correlate with better responses to immunotherapy. Higher baseline levels of IFN-γ and an increase in its production during treatment have been associated with better clinical outcomes in patients receiving immunotherapy such as anti-PD-1\u002FPD-L1 or anti-CTLA4.\n\nTo date, there is no simple, rapid, automated, and standardized test to assess T-cell functionality and quantify the level of immunosuppression in individual patients. To address this medical need, bioMérieux has developed the VIDAS® STIMM™ T RUO automated functional immune test, which can determine a patient's immune status by measuring IFN-γ production by T lymphocytes after stimulation by a mitogen in approximately four hours without human intervention. The aim of this study is to evaluate whether the amount of IFN-γ produced by T lymphocytes, as measured by an automated VIDAS® STIMM™ T functional immune test, correlates with disease progression in patients with advanced\u002Fmetastatic solid tumors treated with standard immunotherapy.",[83,27],"Immunotherapy","2025-08-27",{"date":86,"type":37},"2025-09-04",{"date":88,"type":21},"2025-09-23",{"date":88,"type":21},{"name":91,"class":44},"Centre Leon Berard",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100566017","phase-1-hx044fih-study-in-patients-with-advanced-solid-tumor-malignancies-100566017","NCT06649708","HX044,FIH Study in Patients with Advanced Solid Tumor Malignancies","A Phase I\u002FIIa, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HX044 in Patients with Advanced Solid Tumor Malignancies","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate by providing written informed consent and agreeing to comply with protocol and scheduled visit;\n2. Male or female subject aged 18-75 years, inclusive;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n4. Histologically confirmed advanced malignant solid tumor that is refractory\u002Frelapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.\n5. At least 1 measurable tumor (It is acceptable to allow patients with no measurable lesion but evaluable tumor lesion in the first 2 dose levels in Phase I and at least 1 measurable tumor lesion must be present in Phase IIa) according to RECIST v1.1\n6. Life expectancy ≥ 12 weeks.\n7. Adequate organ function, as indicated by the following laboratory values: •Hematology (no growth factor and blood transfusion are allowed within 14 days before start of first dose study treatment): Hemoglobin ≥90g\u002FL Absolute neutrophil count ≥1.5×109\u002FL Platelet count ≥100×109\u002FL\n\n   * Hepatic: Serum total bilirubin ≤1.5 × upper limit of normal (ULN); or direct bilirubin ≤ULN for patients with total bilirubin levels \\>1.5 × ULN\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver metastases)\n   * Renal:Serum creatinine ≤1.5 × ULN\n   * Coagulation: Prothrombin time\u002Finternational normalized ratio ≤1.5 × ULN or activated partial thromboplastin time ≤ 1.5 × ULN (for subjects on anticoagulants, prothrombin time or activated partial thromboplastin time must be within the normal range foranticoagulants).\n\nExclusion Criteria:\n\n1. Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study and locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast.\n2. Receipt of any anticancer (chemotherapy, radiation therapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy) therapy within 4 weeks prior to the first dose of study treatment or 5 half-lives of the therapy, whichever is shorter.\n3. Severe cardiovascular disease including symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, a history of myocardial infarction within 6 months or a history of arterial thromboembolic event and pulmonary embolism within 3 months of the first dose of investigational agent, as follows:\n\n   * QT\u002FQTc interval prolongation (using Fredericia's QT correction formula) at baseline, Female \\> 470 ms, Male \\> 450 ms;\n   * Medications to prolong the QT\u002FQTc interval are currently being taken;\n   * Family history of long QT syndrome.\n4. Patients with a history of or presently experiencing an active autoimmune disease within 2 years of initiating study drug, or those who are at high risk of relapse ; however, subjects with the following are allowed to enroll:\n\n   * Type I diabetes that is stable after a fixed dose of insulin or other hypoglycemic;\n   * Only requiring hormone replacement therapy for autoimmune hypothyroidism;\n   * Skin disease that does not require systemic treatment such as eczema rash that accounts for \\\u003C10% of the body surface, psoriasis without ophthalmic symptoms.\n5. Subjects who received any major surgery within 4 weeks before the first dose of study treatment (except for diagnostic surgery), and\u002For subjects who may require major surgery during the study.\n6. Lung diseases such as, interstitial lung disease or pneumonia, pulmonary fibrosis, acute lung disease, interstitial pneumonia. Patients with well controlled chronic obstructive pulmonary disease (COPD) are allowed.\n7. Subjects with primary central nervous system (CNS) malignancies, symptomatic CNS metastases, symptomatic parenchymal brain leptomeningeal disease or spinal cord compression, except for the following: who has received prior treatment (surgery\u002Fradiotherapy) before signing informed consent form (ICF) and is clinically stable for at least 3 months is allowed (prior treatment with corticosteroids are permitted but must stop 14 days before commencing study treatment）\n8. Use of any live vaccines within 4 weeks before the first dose of study treatment.\n9. A history of psychotropic substance abuse who is unable to quit.\n10. Any patient with an uncontrolled illness such as cardiovascular and cerebrovascular diseases, diabetes, high blood pressure, et, and other severe, acute or chronic medical or psychiatric diseases or laboratory abnormalities that, in the Investigator's opinion, may increase the study-related risks or interfere with the interpretation of the findings.",{"count":78,"type":21},[24,101],"PHASE2","The study will consist of a dose-escalation and dose-expansion component to establish the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D), and to evaluate the preliminary antitumor activity of HX044.\n\nHX044 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes. This is the first study in which HX044 will be given to humans. The study drug has been tested in animals and was found to be well-tolerated with minimal side effects.",[27],"2025-01-13",{"date":106,"type":37},"2025-01-14",{"date":108,"type":37},"2024-12-30",{"date":110,"type":21},"2027-10-31",{"name":112,"class":68},"Hanx Biopharmaceuticals (Wuhan) Co., Ltd.",3]