[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignant-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignant-tumors":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,51,74,98,119,141,160,181,201,221,246,266,286,307,327],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100574860","phase-1-a-study-of-bms-986488-as-monotherapy-and-combination-therapy-in-participants-with-advanced-malignant-tumors-100574860",false,"NCT06764771","A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors","A Phase 1\u002F1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.\n* Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC).\n* Parts 2A, 1D, 2D: ccRCC.\n\n  i) Part 1B: solid tumors with KRAS G12C mutation.\n\nii) Part 2B: NSCLC with KRAS G12C mutation.\n\niii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.\n\n* Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.\n* Participants must have measurable disease per RECIST v1.1.\n\nExclusion Criteria:\n\n* Untreated central nervous system (CNS) metastases.\n* Leptomeningeal metastasis (carcinomatous meningitis).\n* Impaired cardiac function or clinically significant cardiac disease.\n* For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.\n\n  i) History of pneumonitis or interstitial lung disease (ILD).\n\nii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).\n\n\\- Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},437,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.",[26],"Advanced Malignant Tumors",[28,29,30,31,32,33,34,35,36,37],"Colorectal Cancer","CRC","Renal Cell Carcinoma","RCC","Non-Small Cell Lung Cancer","NSCLC","Cancer","Oncology","Phase 1","Solid Tumor","RECRUITING","2026-07-01",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2025-03-25",{"date":46,"type":20},"2027-10-15",{"name":48,"class":49},"Bristol-Myers Squibb","INDUSTRY",8,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100618993","phase-1-to-evaluate-the-tolerability-and-pharmacokinetics-of-tqb3142-for-injection-in-patients-with-advanced-malignant-tumors-100618993","NCT07338838","To Evaluate the Tolerability and Pharmacokinetics of TQB3142 for Injection in Patients With Advanced Malignant Tumors","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TQB3142 for Injection in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed the informed consent, and had good compliance;\n* 18 years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);\n* Eastern Cooperative Oncology Group Performance Status (ECOG) score 0\\~1;\n* Expected survival greater than 12 weeks;\n* Patients with advanced tumors confirmed by cytology\u002Fhistopathology, failure of standard treatment or lack of effective treatment;\n* Evidence of at least one evaluable lesion according to RECIST 1.1 criteria；\n* The main organs function well and meet the following criteria:\n\n  1. Hemoglobin (HGB) ≥80g\u002FL (Patients with myeloid neoplasms must have hemoglobin level ≥ 60 g\u002FL);\n  2. Absolute neutrophil count (ANC) of solid tumor subjects ≥1.5×109 \u002FL;\n  3. Platelet count (PLT) ≥80×109\u002FL (Patients with myeloid neoplasms must have a platelet count ≥ 30 × 10⁹\u002FL)；\n  4. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);\n  5. Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN. ALT and AST≤5×ULN if accompanied by liver metastasis;\n  6. Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥60 mL \u002Fmin (standard Cockcroft-Gault formula was applied;\n  7. Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);\n* Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\nI. Comorbid Conditions and Medical History:\n\n* Any active malignancy within the 3 years prior to the first dose, except for the specific cancer under study in this trial and locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the lamina propria)\\], carcinoma in situ of the cervix, or carcinoma in situ of the breast).\n* Failure to recover from toxicities and\u002For complications of prior interventions to ≤ Grade 1 per CTCAE, except for alopecia and peripheral neuropathy ≤ Grade 2.\n* Receipt of any blood product transfusion or requirement for hematopoietic growth factor therapy within 28 days prior to the first dose.\n* Bleeding Risk:\n\n  1. Known bleeding diathesis or disorder.\n  2. History of non-chemotherapy-induced thrombocytopenic bleeding or history of platelet transfusion refractoriness within 1 year prior to the first dose.\n  3. Presence or high suspicion of active bleeding\u002Fhemolytic disorders such as Immune Thrombocytopenic Purpura (ITP), Autoimmune Hemolytic Anemia (AIHA), Evans Syndrome, Hemolytic Uremic Syndrome, Thrombotic Thrombocytopenic Purpura (TTP), Disseminated Intravascular Coagulation (DIC).\n  4. Requirement for warfarin, aspirin, or other anticoagulant\u002Fantiplatelet agents for any reason within 28 days prior to treatment initiation.\n  5. Uncontrolled or CTCAE ≥ Grade 2 bleeding events (e.g., gastrointestinal bleeding) or history of hemoptysis (\\> 2.5 mL of fresh blood per day) within 90 days prior to the first dose.\n  6. Major surgical treatment or significant traumatic injury (excluding procedures like needle biopsy, endoscopic biopsy) within 28 days prior to the first dose.\n  7. Non-healing wounds or fractures (excluding pathological fractures).\n* Arterial\u002Fvenous thrombotic events within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n* History of drug (psychoactive substances) or alcohol abuse with inability to abstain, or presence of psychiatric disorders.\n* Subjects with any severe and\u002For uncontrolled diseases, including:\n\n  1. Poorly controlled blood pressure (systolic BP ≥ 150 mmHg or diastolic BP ≥ 100 mmHg) despite treatment with two or more antihypertensive medications.\n  2. Myocardial ischemia or myocardial infarction ≥ Grade 2, arrhythmias, and congestive heart failure ≥ Grade 2 (NYHA classification).\n  3. History or presence of non-infectious pneumonitis requiring corticosteroid treatment (including but not limited to Acute Respiratory Distress Syndrome, Acute Hypersensitivity Pneumonitis, Drug-Related Pneumonitis, Bronchospasm, Acute Interstitial Pneumonia, Idiopathic Pulmonary Fibrosis, etc.).\n  4. History, presence, or suspicion of Chronic Obstructive Pulmonary Disease (COPD) with Forced Expiratory Volume in 1 second (FEV1) \\\u003C 60% of predicted value.\n  5. Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection).\n  6. Diagnosis of Coronavirus Disease 2019 (COVID-19) infection within 3 months prior to the first dose.\n  7. Decompensated cirrhosis (Child-Pugh class B or C), active hepatitis:\n\n     * Hepatitis B reference: Hepatitis B Virus (HBV) - DNA \\> 1\\*10³ copies\u002FmL or \\>2000 IU\u002FmL if HBsAg positive.\n     * Hepatitis C reference: Hepatitis C Virus (HCV) RNA above the upper limit of normal.\n\n     (Note: Eligible subjects who are HBsAg positive or anti-Hepatitis B core (HBc) antigen positive, or have hepatitis C, require continuous antiviral therapy to prevent viral reactivation.)\n  8. Active syphilis.\n  9. Renal abnormalities:\n\n     * Renal failure requiring hemodialysis or peritoneal dialysis.\n     * History or presence of nephrotic syndrome (except if cured), chronic nephritis.\n  10. History of immunodeficiency, including HIV positivity or other acquired\u002Fcongenital immunodeficiency diseases; history of active autoimmune disease or autoimmune diseases including but not limited to Crohn's disease, ulcerative colitis, autoimmune hepatitis\u002Fenteritis\u002Fvasculitis\u002Fnephritis, etc.; or history of organ transplantation (except corneal transplant).\n  11. Presence or history of autoimmune disease requiring treatment. Subjects with hypothyroidism on stable replacement therapy or Type 1 diabetes mellitus may be eligible.\n  12. Urinalysis showing urine protein ≥ ++, and confirmed 24-hour urinary protein \\> 1.0 g (except for subjects with multiple myeloma).\n  13. Poorly controlled diabetes (Fasting Blood Glucose \\> 10 mmol\u002FL).\n  14. Epilepsy requiring treatment.\n\nII. Tumor-Related Symptoms and Treatment:\n\n* Known central nervous system (CNS) involvement or carcinomatous meningitis; subjects with solid tumors who have received treatment for brain metastases and have been clinically stable for at least 28 days prior to the first dose without requiring steroids or other therapy for brain metastases may be eligible.\n* Prior chemotherapy, targeted therapy, radiotherapy, or other anti-tumor therapy within 4 weeks before the first dose (calculation based on the end date of the last treatment for washout period).\n* Prior allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, or other cell therapies (e.g., Chimeric Antigen Receptor T-cell \\[Chimeric Antigen Receptor T-cell Therapy (CAR-T)\\] therapy).\n* Treatment within 2 weeks prior to the first dose with Chinese patent medicines approved by the National Medical Products Administration (NMPA) with clearly stated anti-tumor indications in their package inserts (including Fufang Banmao Capsule, Kang'ai Injection, Kanglaite Capsule\u002FInjection, Aidi Injection, Yadanzi Oil Injection\u002FCapsule, Xiaoaiping Tablet\u002FInjection, Huachansu Capsule, etc.).\n* Serous cavity (pleural, peritoneal, or pericardial) effusion requiring repeated drainage for symptomatic relief (investigator's judgment), or receipt of therapeutic serous cavity effusion drainage within 2 weeks prior to treatment.\n* Imaging (CT or MRI) showing tumor invasion of major blood vessels, or the investigator judges a high probability of fatal hemorrhage due to tumor invasion of major blood vessels during the study period.\n\nIII. Study Treatment-Related:\n\n* Prior treatment with B-cell lymphoma-extra large (Bcl-xL) inhibitors.\n* History of live attenuated vaccination within 4 weeks prior to the first dose or planned live attenuated vaccination during the study period.\n* Known allergy to any component of the study drug(s).\n* Requirement for or use of strong inhibitors or inducers of Cytochrome P450 3A (CYP3A) within 2 weeks prior to the first dose (medications or food).\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n* Diagnosis of immunodeficiency or current systemic glucocorticoid therapy (at a dose equivalent to \\>10 mg\u002Fday prednisone or equivalent) or any other form of immunosuppressive therapy (including but not limited to cyclosporine A, tacrolimus, cyclophosphamide, etc.) continued within 2 weeks prior to study treatment initiation. Exceptions include: ① Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids are permitted. ② Short-term use of corticosteroids for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction from contact allergen) is permitted.\n* Participation in another anti-tumor drug clinical trial within 4 weeks prior to the first dose or within 5 drug half-lives (whichever is shorter).","75 Years",{"count":60,"type":20},66,[23],"To explore the safety, tolerability and pharmacokinetics of TQB3142 for injection in subjects with advanced malignant tumors",[26],"2026-06-22",{"date":66,"type":42},"2026-06-23",{"date":68,"type":42},"2026-02-26",{"date":70,"type":20},"2028-06",{"name":72,"class":49},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",5,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100624448","early-phase-1-a-phase-i-platform-study-of-target-based-screened-car-macrophages-for-the-treatment-of-advanced-malignant-tumors-100624448","NCT07409766","A Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive) at the time of signing the informed consent form, with no gender restriction.\n* Histologically or cytologically confirmed advanced solid tumor (partial laboratory test results are acceptable):\n\nHER2-positive: IHC 3+ or IHC 2+ with ISH+ PSMA+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10% FAP+++: Intensity score 2+ with proportion ≥ 30%, or intensity score 3+ with proportion ≥ 10%\n\nDisease status:\n\nSubjects (HER2-targeted): Patients with advanced solid tumor who are refractory to or intolerant of DS-8201 treatment.\n\nSubjects (PSMA-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment.\n\nSubjects (FAP-targeted): Patients with advanced solid tumor who are refractory to or intolerant of first- or second-line treatment.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Life expectancy of at least 3 months (as assessed by the investigator).\n* Adequate organ function, defined as follows:\n\nHematologic: Hemoglobin ≥ 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count ≥ 80 × 10⁹\u002FL Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver metastases) Renal: Serum creatinine ≤ 1 × ULN, or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% (assessed by ECHO or MUGA) Pancreatic: Serum amylase \u002F lipase ≤ 1.5 × ULN\n\n* Electrolytes: Corrected calcium, potassium, and magnesium levels within the normal range.\n* Subjects must have at least one measurable lesion as defined by RECIST Version 1.1.\n* Adequate venous access for apheresis with no contraindications.\n* Tolerability to G-CSF: No history of severe hypersensitivity to filgrastim or its biosimilars.\n* Subjects must fully understand the purpose, nature, methods, and potential adverse reactions of the study, and voluntarily participate in the study and sign the informed consent form prior to initiation of any study procedures.\n\nExclusion Criteria:\n\n* Known hypersensitivity to CAR-M or any of its excipients.\n* History of severe hypersensitivity to filgrastim (G-CSF) or tocilizumab.\n* Known history of substance abuse.\n* A history of ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-related myocarditis following prior immunotherapy.\n* Active infection requiring systemic therapy, except for the following conditions: uncomplicated urinary tract infection (UTI) (afebrile and resolved after 3 days of antibiotic therapy) or bacterial pharyngitis (confirmed by GAS testing and treated with appropriate antibiotics).\n* HIV infection, active hepatitis B virus (HBV) infection (HBV DNA \\> upper limit of normal \\[ULN\\]), or active hepatitis C virus (HCV) infection (HCV RNA \\> ULN).\n* History of malignant neoplasm other than the following within the past 5 years:\n\nCurable malignant neoplasms (e.g., basal cell carcinoma, carcinoma in situ of the cervix\u002Fbreast, or cutaneous squamous cell carcinoma).\n\n* Malignant neoplasms with a favorable prognosis (e.g., papillary thyroid carcinoma, carcinoma in situ of the skin or breast), regardless of whether they have been cured or not.\n* Receipt of other investigational drugs or therapies within 4 weeks prior to the first administration of CAR-M, or ongoing participation in the safety follow-up period of other investigational drugs or therapies.\n* Presence of severe, non-healing wounds, ulcers, or fractures within 4 weeks prior to the first administration of CAR-M.\n* History of substance abuse or psychiatric disorders.\n* History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n* Acute events: myocardial infarction, stroke, or New York Heart Association (NYHA) Class III-IV heart failure within 6 months.\n* Thromboembolism: symptomatic deep vein thrombosis or pulmonary embolism (DVT\u002FPE) within 6 months (unless on stable anticoagulant therapy).\n* Arrhythmia: ventricular arrhythmia requiring intervention or Grade II-III atrioventricular block.\n* Confirmed pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, or severe pulmonary dysfunction.\n* For patients with prior treatment: ≥ Grade 2 hematological toxicity or ≥ Grade 3 non-hematological toxicity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, except for toxicities deemed to pose no safety risk by the investigator (e.g., alopecia, Grade 2 peripheral neuropathy).\n* Indwelling catheters\u002Fdrainage tubes (excluding central venous catheters).\n* Central nervous system (CNS) disorders: epilepsy, stroke, dementia, or autoimmune diseases involving the CNS.\n* Active or untreated brain or CNS disorders, including brain metastases that have not stabilized for ≥ 8 weeks after radiotherapy, symptomatic brain metastases, or cytologically confirmed carcinomatous meningitis.\n\nSevere immunodeficiency.\n\n* History of prior transplantation: allogeneic stem cell transplantation or solid organ transplantation.\n* Active autoimmune disease requiring systemic immunosuppression (prednisone dose \\> 10 mg\u002Fday or equivalent).\n* History of high-risk autoimmune diseases with potential for recurrence (e.g., systemic lupus erythematosus \\[SLE\\], rheumatoid arthritis \\[RA\\], inflammatory bowel disease \\[IBD\\]). Exceptions: stable vitiligo\u002Fpsoriasis, hormone-replaced hypothyroidism, or well-controlled Type 1 diabetes mellitus (HbA1c ≤ 7%).\n* Use of systemic glucocorticoids (prednisone \\> 10 mg\u002Fday) or other immunosuppressants within 14 days (exceptions: topical\u002Finhaled steroids, adrenal replacement therapy).\n* Receipt of major organ surgery, severe trauma, or invasive dental procedures (e.g., tooth extraction, dental implantation) within 4 weeks prior to the first administration of CAR-M, or planned elective surgery during the study period.\n* Active autoimmune disease or history of recurrent autoimmune disease (excluding well-controlled Type 1 diabetes mellitus; hypothyroidism manageable with hormone replacement therapy alone; or dermatological conditions not requiring systemic therapy, e.g., vitiligo or psoriasis).\n* Presence of active infection requiring systemic anti-infective therapy.\n* Positive pregnancy test in women of childbearing potential (WOCBP).\n* Refusal to use effective contraceptive measures from the time of informed consent until 1 year after treatment.",{"count":81,"type":20},20,[83],"EARLY_PHASE1","This is a single-arm, open-label, single-center, dose-escalation platform clinical trial design. Using an adenovirus vector platform, the study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of investigational CAR-M macrophage injections targeting various antigens (including HER2, PSMA, FAP, etc.) in patients with advanced solid tumors. The clinical trial is designed to be conducted in cohorts, with patients enrolled into respective cohorts based on target antigen and indication screening",[26],"NOT_YET_RECRUITING","2026-02-08",{"date":89,"type":42},"2026-02-13",{"date":91,"type":20},"2026-01-31",{"date":93,"type":20},"2028-12-31",{"name":95,"class":96},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":97},"100595865","phase-1-a-phase-i-study-of-spgl008-in-subjects-with-advanced-malignant-tumors-100595865","NCT07038005","A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Males and\u002For females, 18-75 years old;\n2. Histologically and\u002For cytologically documented advanced or metastatic malignant Tumors;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n4. Expected survival \\>=3 months;\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease;\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI-CTCAE\\] v.5.0);\n3. Inadequate organ or bone marrow function;\n4. Pregnant or breast-feeding woman;\n5. Known allergies, hypersensitivity, or intolerance to SPGL008.",{"count":106,"type":20},96,[23],"This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.",[26],"2026-02-05",{"date":112,"type":42},"2026-02-09",{"date":114,"type":42},"2025-07-30",{"date":116,"type":20},"2027-06-08",{"name":118,"class":49},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":97},"100583540","phase-1-first-in-human-investigation-of-jmt108-injection-in-participants-with-advanced-malignant-tumors-100583540","NCT06877650","First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors.","Inclusion Criteria:\n\n1. Fully informed of the study, with good compliance and willing to provide written informed consent.\n2. Male or female participants aged ≥18 years (at the time of obtaining informed consent).\n3. Participants with histologically or cytologically confirmed advanced malignant tumors who are unresponsive or intolerant to all standard of care, or have no standard of care available. For locally advanced (stage IIIB\u002FIIIC) or metastatic (stage IV) NSCLC without sensitive gene mutations, participants who have not received systemic treatment in the advanced stage and are unwilling to accept the current standard treatment can also be enrolled in the cohort expansion phase.\n4. Participants with at least one evaluable tumor lesion in the Phase 1a dose-escalation phase; and at least one measurable lesion in the Phase 1a dose-expansion phase and Phase 1b (tumor lesions in the past radiation fields or that underwent locoregional therapy are generally not considered measurable lesions unless the lesion shows definite progression or persists three months after radiotherapy) according to RECIST v1.1.\n5. Stage I: ECOG performance score ≤ 2. Stage II: ECOG performance score 0-1\n6. Expected survival ≥ 3 months.\n7. Adequate organ function status:\n\nHematology: PLT ≥ 100×109\u002FL; Hb ≥ 90 g\u002FL; ANC) ≥ 1.5×109\u002FL (No blood transfusion, platelet transfusion, or hematopoietic stimulating factor therapy within 14 days prior to hematology test during the screening period); Liver function: AST and ALT ≤3×ULN (≤5×ULN if there is liver involvement by the tumor); TBIL ≤1.5×ULN; Renal function: Ccr \\> 50 ml\u002Fmin (calculated by the Cockcroft-Gault formula); Coagulation function: APTT ≤ 1.5×ULN; INR ≤ 1.5×ULN; For participants on full - dose oral anticoagulant therapy, maintain a stable dosage for at least 14 days. If on warfarin, INR ≤ 3.0 with no active hemorrhage (e.g., no bleeding 14 days before the first dose of the investigational drug). Low molecular weight heparin use is permitted.\n\nAlbumin: ≥30 g\u002FL (≥3.0 g\u002FdL).\n\nExclusion Criteria:\n\n1. Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).\n2. Chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor therapies within 4 weeks prior to the first dose of the investigational drug, except in the following situations:\n\n   Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug; Use of oral fluoropyrimidines and small-molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of the investigational drug; Use of herbal medicine\u002Fproducts with anti-tumor indications within 2 weeks prior to the first dose of the investigational drug.\n3. Major surgery (excluding biopsy) or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug, or plan to do major surgery during the study period.\n4. Systemic corticosteroids or other immunosuppression therapy within 14 days prior to the first dose of the investigational drug. Except for the following situations: use of physiological replacement doses of hydrocortisone or other equivalent doses of hormones (i.e., prednisone ≤10 mg\u002Fday or other equivalent doses of hormones); use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid therapy; use of short-course glucocorticoids for prophylaxis (e.g., prevention of contrast allergy).\n5. Live vaccines within 4 weeks prior to the first dose of investigational drug. Note: Seasonal influenza vaccines are inactivated vaccines in a broad sense and are allowed. Intranasal influenza vaccines are live vaccines and are not permitted.\n6. History of hematopoietic stem cell transplant or organ transplant.\n7. AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0 (excluding toxicities evaluated by the investigator to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized with hormone replacement therapy, etc.).\n8. Active central nervous system metastases and\u002For leptomeningeal metastases. Participants with brain metastases who have confirmed progression-free status by imaging examinations for at least 4 weeks after treatment and who have not required hormonal or antiepileptic therapy for at least 2 weeks may be considered for enrollment.\n9. History of interstitial lung disease or pneumonitis.\n10. History of serious cardiovascular and cerebrovascular diseases.\n11. Active or recurrent autoimmune diseases (such as systemic lupus erythematosus, arthritis, vasculitis, etc.).\n12. History of Grade ≥3 immune-related AE or Grade ≥2 immune-related myocarditis considered related to prior immune modulatory therapytherapy.\n13. Hemorrhage of Grade ≥2 as per NCI CTCAE v5.0 within 4 weeks prior to the first dose of the investigational drug.\n\n    \\-",{"count":127,"type":20},436,[23,129],"PHASE2","This study is designed as an open-label, multi-center Phase 1 clinical study in participants with advanced malignant tumors to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor activity of JMT108 injection, and to determine the RP2D\u002Fschedule for subsequent studies.",[26],"2026-01-27",{"date":134,"type":42},"2026-01-29",{"date":136,"type":42},"2025-04-11",{"date":138,"type":20},"2029-03-30",{"name":140,"class":49},"Shanghai JMT-Bio Inc.",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":97},"100594211","phase-1-a-phase-1-study-of-ssgj-709-in-patients-with-advanced-malignant-tumors-100594211","NCT07016490","A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors","A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Minimum life expectancy of 3 months;\n* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0-1;\n* Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology; preferred tumor types for enrollment include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma. Subjects with other tumor types may be enrolled after discussion with the sponsor；\n* Subject who have failed, or has been intolerant to standard therapy, or has been considered lack standard of care for a given tumor type, and who is not able to complete surgical resection and receive curative concurrent\u002Fsequential chemoradiotherapy；\n* Having at least one measurable tumor lesion as the target lesion assessed per RECIST v1.1；\n* The subject has adequate hematological and organ functions；\n\nExclusion Criteria:\n\n* Presence of brainstem, meningeal metastases, spinal cord metastases or compression；\n* Presence of active central nervous system (CNS) metastases；\n* Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require repeated drainage；\n* Subjects with other malignant tumors within 3 years prior to screening；\n* Subjects with autoimmune diseases that require systemic treatment within 2 years before screening；\n* Subjects are positive for human immunodeficiency virus (HIV)；\n* Prior or current presence of non-infectious pneumonia\u002Finterstitial lung disease requiring systemic therapy with glucocorticoids；\n* Serious infection within 4 weeks prior to the first dose or the presence of any active infection requiring systemic anti-infective therapy.\n* Having received the following treatments prior to the first dose of study treatment:\n\n  1. Having received anti-tumor therapies such as biological agents, chemotherapy and other investigational drugs not approved for marketing within 3 weeks prior to the first dose of study treatment (Patient may be enrolled if the first dose of study treatment is more than 5 half-lives of the drug from the last anti-tumor therapy);\n  2. Having received small molecule targeted antineoplastic agents (e.g., tyrosine kinase inhibitor), or palliative local therapy for non-target lesions, or non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor) within 2 weeks prior to the first dose;\n  3. Having received herbal medicine with an anti-tumor indication within 1 week prior to the first dose;\n  4. Prior immunotherapy other than anti-PD-(L)1 therapy (Patients with prior immunotherapy against other targets may be enrolled after discussion and agreement with the sponsor).",{"count":5,"type":20},[23],"This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies.",[26],"2026-01-26",{"date":154,"type":42},"2026-01-28",{"date":156,"type":42},"2025-06-12",{"date":158,"type":20},"2027-12-30",{"name":118,"class":49},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":180},"100596307","phase-1-a-clinical-trial-evaluating-injection-of-tqb6411-in-subjects-with-advanced-malignant-tumors-100596307","NCT07043751","A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors","A Phase I Clinical Trial Evaluating the Tolerance, Pharmacokinetics and Preliminary Efficacy of Injection TQB6411 in Subjects With Advanced Malignant Tumors","Inclusion Criteria:\n\n* The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;\n* 18 years old≤age age≤75 years old (calculated based on the date of signing the informed consent form);\n* Eastern Cooperative Oncology Group (ECOG) score 0\\~1 point;\n* Expected survival is greater than 12 weeks;\n* According to the RECIST v1.1 standard, there is at least one evaluable tumor lesion in the dose escalation stage, and at least one measurable lesion in the dose expansion stage;\n* Laboratory examination standards that meet the program requirements (no use of hematopoietic stimulator drugs for correction within 7 days);\n* Subjects who failed or were intolerant of standard treatment;\n* Subject requirements for the dose expansion stage: advanced NSCLC; metastatic colon cancer; recurrent\u002Fmetastatic esophageal squamous cell carcinoma; recurrent\u002Fmetastatic nasopharyngeal carcinoma; advanced malignant solid tumor;\n* Can provide tumor tissue specimens that meet the requirements for immunohistochemical testing;\n* Women of childbearing age should agree that effective contraception must be adopted during the study period and within 6 months after the end of the study, and that the serum or urine pregnancy test will be negative within 7 days before the study enrollment; men should agree that effective contraception must be adopted within 6 months after the end of the study period;\n\nExclusion Criteria:\n\n* Have appeared or are currently suffering from other malignant tumors;\n* There are diseases that affect intravenous injection and intravenous blood collection;\n* The adverse reactions of previous treatments failed to recover to CTCAE V5.0 grade score ≤1, except for toxicity without safety risk, such as grade 2 hair loss, grade 2 peripheral nerve toxicity, grade 2 anemia, non-clinical significance and asymptomatic grade 2 laboratory abnormalities, stable hypothyroidism with hormone replacement therapy;\n* Those who have received major surgical treatment, obvious traumatic injury or major surgery during the expected study treatment within 4 weeks before the first medication (except for the surgery stipulated in the program), or have long-term uncured wounds or fractures;\n* Subjects with any bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;\n* Arterial\u002Fvenous thrombosis events occurred within 6 months before the first dose;\n* People with active viral hepatitis and poor control;\n* People infected with active syphilis who need treatment;\n* There is a history of active tuberculosis, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia\u002Fradio-pneumonia that needs treatment, or active pneumonia with obvious clinical symptoms, and interstitial lung disease (ILD) that needs treatment, or currently associated with interstitial lung disease;\n* Those with a history of abuse of psychotropic substances and cannot quit or have mental disorders;\n* Preparing for or having previously received allogeneic bone marrow transplants or solid organ transplants;\n* Have a history of hepatic brain disease;\n* Suffering from major cardiovascular disease;\n* Severe infection that is active or uncontrollable (≥CTC AE grade 2 infection);\n* People who require hemodialysis or peritoneal dialysis if renal failure is required;\n* Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency diseases;\n* Subjects who have poorly controlled autoimmune diseases and need to use immunosuppressive agents or systemic hormones to achieve immunosuppressive purposes and still need to continue using them within 7 days before the first dose (except for daily dose of glucocorticoid \\\u003C10 mg prednisone or other therapeutic hormones);\n* People with epilepsy and need treatment;\n* Poor diabetes control \\[fasting blood sugar (FBG) \\> 10mmol\u002FL\\];\n* Tumor-related symptoms and treatment: subjects who have received chemotherapy, immunotherapy, small molecule targeted drugs, etc. within 3 weeks before the first dose, or are still in the 5 half-life of the drug; within 1 week before the first dose, they have received Chinese patent medicine treatment with anti-tumor indications in the National Medical Products Administration (NMPA) approved drug instructions; imaging (CT or MRI) shows that the tumor has invaded important blood vessels or the researchers judged that the tumor is very likely to invade important blood vessels during the subsequent study and causing fatal major bleeding; if it is not controlled, pleural effusion, pericardial effusion or moderate and severe ascites that still require repeated drainage; known to suffer from spinal cord compression, meningeal metastasis\u002Fcancer meningitis, accompanied by brain metastasis symptoms or symptoms\u002Fimage control time is less than 4 weeks;\n* Known allergies to research drugs or excipients;\n* Have received previous treatment for Epidermal Growth Factor Receptor (EGFR)\u002Fc-Mesenchymal-epithelial transition dual anti-ADC drugs;\n* Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;\n* According to the researcher's judgment, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the study.",{"count":168,"type":20},216,[23],"TQB6411 for injection is an antibody-conjugated drug (ADC) targeting EGFR\u002Fc-Met. After injecting blood intravenously, the antibody part of this product binds to the surface of EGFR and c-Met on tumor cells to block the activation of EGFR and c-Met signaling pathways. The ADC is enzymatically transported to the lysosome. The linker releases toxins after enzyme cleavage, resulting in DNA damage and cell death. TQB6411 for injection is intended for the treatment of advanced malignant tumors.",[26],"2026-01-18",{"date":174,"type":42},"2026-01-21",{"date":176,"type":42},"2025-07-15",{"date":70,"type":20},{"name":179,"class":49},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",19,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":97},"100595426","phase-1-a-phase-i-study-of-ssgj-612-in-patients-with-advanced-solid-tumors-100595426","NCT07032298","A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors","Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;\n2. Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;\n3. Expected survival ≥3 months;\n4. Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;\n5. Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent\u002Fsequential chemoradiotherapy;\n6. Tumor tissue with HER2 expression;\n7. At least one measurable tumor lesion assessed as the target lesion according to RECIST v1.1 criteria, and the lesion is suitable for repeated and accurate measurement.\n\nExclusion Criteria:\n\n1. Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;\n2. Presence of active central nervous system (CNS) metastatic lesions;\n3. Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;\n4. Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;\n5. Known active tuberculosis; known active syphilis infection;\n6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n7. Use of any live vaccine or attenuated live vaccine within 4 weeks before the first dose, or plan to receive any live vaccine or attenuated live vaccine during the study;\n8. Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies;\n9. Pregnant or lactating women.",{"count":189,"type":20},30,[23],"This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.",[26],"2025-07-22",{"date":195,"type":42},"2025-07-25",{"date":197,"type":42},"2025-07-18",{"date":199,"type":20},"2026-06",{"name":118,"class":49},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":97},"100506014","phase-1-a-phase-iaib-open-labelclinical-study-evaluating-the-safety-tolerability-and-preliminary-efficacy-of-ak127-in-combination-with-ak104-in-patients-with-advanced-malignant-tumors-100506014","NCT05868876","A Phase Ia\u002FIb Open Label，Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of AK127 in Combination With AK104 in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* 1.The subject must sign the written informed consent form(ICF) voluntarily. 2.Aged ≥ 18 to ≤ 75 years,male and female at the time of enrollment. 3.Eastern Cooperative Oncology Group(ECOG) performance status score of 0 or 1. 4.Life expectancy≥ 3 months. 5.Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic malignancies were enrolled in the phase Ia dose escalation phase;Selected tumor species were enrolled in phase Ib dose extension.Patients with advanced metastatic malignancies who have failed first-line, or second-line, or third-line, or fourth-line standard therapies, or who not appropriate for standard treatment, cannot tolerate chemotherapy, or do not have effective standard therapies.\n\n  6\\. According to RECIST v1.1, there is at least one measurable lesion, and the lesion is suitable for repeated accurate measurement;Brain metastases cannot be used as target foci.\n\n  7\\. Good organ function. 8. The serum pregnancy test results of female subjects in the child-bearing age within 3 days before the first medication were negative; 9. If a fertile female subject has sex with an unsterilized male partner, the subject must begin from screening for effective contraceptive methods and must agree to continue using these precautions until 6 months after the last administration of the study drug;Periodic abstinence, safe period contraception and external ejaculation are not acceptable contraceptive methods.\n\n  10\\. If an unsterilized male subject has sexual intercourse with a fertile female partner, the subject must use an effective contraceptive method from the beginning of screening to within 6 months after the last dose.\n\nExclusion Criteria:\n\n* 1\\. Previous treatment for:Use of small-molecule targeted antitumor drugs, monoclonal or double-clonal antibodies targeting PD-(L)1 or CTLA-4, other anti-tumor antibodies, other anti-tumor therapies (e.g., chemotherapy, radiotherapy, biological or hormonal therapy) within 4 weeks prior to initial administration of the study drug, previous use of immunomodulatory drugs within 2 weeks prior to initial administration of the study drug,Prior treatment with approved or investigational TIGIT antibodies, PVRIG antibodies, or CD96 antibodies.\n\n  2\\. Enroll in another clinical study at the same time. 3. Received other antitumor therapy 4 weeks before the first administration or 5 half-lives of the drug (whichever is shorter) : e.g. palliative local therapy for non-target lesions was performed within 2 weeks before the first administration;Received non-specific immunomodulatory therapy within 2 weeks prior to initial administration;Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week prior to initial administration.\n\n  4\\. Central nervous system metastasis with clinical symptoms. 5. Other malignancies within 3 years prior to the first medication. 6. Active autoimmune disease requiring systemic treatment within 2 years prior to initial medication.\n\n  7\\. History of serious disease within 1 year before the first medication. 8. History of gastrointestinal perforation and\u002For fistula, history of gastrointestinal obstruction, and extensive enterectomy within 6 months prior to initial administration.\n\n  9\\. Patients receiving chest radiotherapy \\>30 Gy within 6 months before the first drug use, non-chest radiotherapy \\>30 Gy within 4 weeks before the first drug use, and palliative radiotherapy ≤30 Gy within 2 weeks before the first drug use.Subjects who did not recover from toxicity and\u002For complications from these interventions to NCI CTCAE grade ≤1 (except hair loss and fatigue).\n\n  10\\. Live or attenuated vaccine has been administered within 4 weeks prior to initial administration, or if it is planned to be administered during the study period. Inactivated vaccine is permitted .\n\n  11\\. Severe infection occurs within 4 weeks prior to first dosing. 12. Those who have had major surgical operations or severe trauma within 4 weeks prior to the first dosing, or have major surgical operations planned within 4 weeks after the first dosing; Minor local surgery was performed within 3 days prior to first dosing.\n\n  13\\. History of severe bleeding tendency or coagulopathy;There were clinically significant bleeding symptoms, including but not limited to gastrointestinal bleeding, hemoptysis, and nasal bleeding, within 4 weeks prior to first dosing .\n\n  14\\. Systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive medication with present hypertension.\n\n  15\\. Hyperglycemia that has not been controlled by treatment. 16. Pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage.\n\n  17\\. There is a history of noninfectious pneumonia requiring systemic glucocorticoid therapy or a current interstitial lung disease.\n\n  18\\. Active or have a clear history of inflammatory bowel disease. 19.History of immune deficiency; HIV antibody positive; Systemic corticosteroid hormones or other immunosuppressants are currently being used long-term.\n\n  20\\. Known history of allogeneic organ transplantation and hematopoietic stem cell transplantation.\n\n  21\\. Untreated subjects with active hepatitis B;Active hepatitis C subjects. 22. No remission of toxicity from previous antitumor therapy, defined as failure to return to the grade 1 level of toxicity defined in NCI, CTCAE 5.0 or below, or the inclusion\u002Fexclusion criteria, with the exception of alopecia and fatigue.\n\n  23\\. Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.",{"count":208,"type":20},205,[23],"A Phase Ia\u002FIb open label，clinical study evaluating the safety, tolerability and preliminary efficacy of AK127 in combination with AK104 in patients with advanced malignant tumors",[26],"2025-02-28",{"date":214,"type":42},"2025-03-03",{"date":216,"type":42},"2023-06-29",{"date":218,"type":20},"2026-02",{"name":220,"class":49},"Akeso",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":97},"100515444","phase-1-a-clinical-trial-to-evaluate-effect-of-ibb0979-in-patients-with-advanced-malignant-tumors-100515444","NCT05991583","A Clinical Trial to Evaluate Effect of IBB0979 in Patients With Advanced Malignant Tumors","A Phase I\u002FII Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBB0979 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female, 18 to 80 years old.\n2. With histologically or cytologically confirmed locally advanced or metastatic solid malignant tumors, either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate.\n3. There is at least one assessable tumor lesion in the Dose Escalation Phase and at least one measurable lesion in the Dose Expansion Phase According to RECIST 1.1 (tumor lesions located in the previous radiation therapy area or other local regional treatment area generally not be considered as measurable lesions, unless the lesion has progression or persists after three months of radiation therapy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥ 3 months.\n6. Adequate organ functions:\n\n   * Hematologic system (no transfusion or hematopoietic-stimulating factor therapy within 14 days): absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, platelet count (PLT) ≥ 90 × 109\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL.\n\n     * Liver function: total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal values (ULN), except for Gilbert's syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN, liver metastases or liver cancer patients with ALT and AST ≤ 5.0 × ULN.\n\n       * Renal function: estimated creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated according to the Cockcroft-Gault formula).\n\n         * Thrombin function: international normalized ratio of prothrombin (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n7. Eligible patients with fertility (male and female) must agree to use reliable contraceptive measures (include hormonal contraceptives, barrier contraception or abstinence) with their partners from the time of consent through 90 days after discontinuation of investigational product administration. Female patients of childbearing potential (not surgically sterilized and between menarche and 1- year postmenopause) must have a negative serum pregnancy test within 7 days prior to the initiation of investigational product administration.\n8. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures.\n\nExclusion Criteria:\n\n1. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.\n2. History of anti-tumor therapy (chemotherapy within 3 weeks or radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration, with the following exceptions:\n\n   * Nitrosourea or mitomycin C should be within 6 weeks prior to the initiation of investigational product administration.\n\n     * Oral fluoropyrimidines and small molecule targeted drugs should be within 2 weeks prior to the initiation of investigational product administration.\n3. History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.\n4. History of major organ surgery (with exception of aspiration biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product administration, or selective operation is required during the trial.\n5. History of systemic corticosteroids (prednisone \\>10 mg per day or equivalent) or other immune-suppressive drugs within the 14 days prior to the initiation of investigational product administration. Steroids for topical, ophthalmic, intraarticular, inhaled or nasal administration are allowed.\n6. Treatment with immunomodulatory agents, including but not limited to thymosin, interleukin-2 and interferon within 14 days prior to the initiation of investigational product administration.\n7. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.\n8. History of prior allogeneic stem-cell or solid organ transplantation.\n9. The adverse effects of previous anti-tumor therapy have not yet returned to ≤ Grade 1 (NCI-CTCAE 5.0) or rules of the inclusion criteria (with exception of that the investigator judged to be without safety risks, such as hair loss, Grade 2 peripheral neurotoxicity, stable hypothyroidism with hormone replacement therapy, etc.).\n10. Active brain or leptomeningeal metastases with clinical symptoms. Patients with brain metastases are eligible if these have been treated and MRI or CT shows no evidence of progression for at least 8 weeks after treatment completion and within 4 weeks prior to the initiation of investigational product.\n11. Evidence of active infection requiring intravenous anti-infective therapy.\n12. Active hepatitis B (HBsAg-positive, and HBV-DNA\\> 500 IU\u002FmL or lower limit of study site \\[only if the lower limit of study site is above 500 IU\u002FmL\\]), active hepatitis C (HCV-RNA\\> lower limit of study site).\n13. Currently has interstitial lung disease (with exception of radiation pulmonary fibrosis that requires no hormone therapy).\n14. History of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    * Severe heart rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II\u002FIII-degree atrioventricular block, etc.\n\n      * The mean QT interval (QTcF) \\> 470 ms corrected by Fridericia's method.\n\n        * Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of ≥ grade 3 within 6 months prior to the initiation of investigational product.\n\n          * Congestive heart failure (New York Heart Association \\[NYHA\\] class ≥ grade II) or left ventricle ejection fraction (LVEF) \\\u003C 50%, or other structural heart disease at high risk by the investigator.\n\n            * Clinically uncontrolled hypertension.\n15. Active or suspected autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), with exception of clinically stable autoimmune thyroid disease, type I diabetes, vitiligo, cured atopic dermatitis in children and psoriasis without systemic treatment (within the past 2 years).\n16. History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2 immune-associated myocarditis accompanied with immunotherapy, with exception of ≥ Grade 3 immune-associated thyrotoxicosis.\n17. History of another malignancy or a concurrent malignancy. Exceptions include patients who have been disease free for two years for non-melanoma skin cancer, localized prostate cancer or carcinoma in situ (e.g., cervical cancer in situ), etc.\n18. Clinically uncontrolled effusion in the third space, which is unsuitable for participation in the study by the investigator.\n19. Known alcohol or drug dependence.\n20. History of mental disorder or poor adherence.\n21. The female patient who is pregnant or breastfeeding. History of other severe systemic disease, or any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study.","80 Years",{"count":230,"type":20},25,[23,129],"This is a Phase 1\u002F2, open-label, dose escalation and dose expansion study designed to characterize the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of IBB0979 in previously treated patients with locally advanced or metastatic solid tumors.",[26],[26,235,236],"B7-H3","IL-10","2025-01-15",{"date":239,"type":42},"2025-01-17",{"date":241,"type":42},"2023-07-03",{"date":243,"type":20},"2025-12-30",{"name":245,"class":49},"SUNHO（China）BioPharmaceutical CO., Ltd.",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100575330","phase-1-jskn033-in-chinese-subjects-with-advanced-malignant-tumors-100575330","NCT06770881","JSKN033 in Chinese Subjects with Advanced Malignant Tumors","Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Antitumor Activity of JSKN033 in Chinese Subjects with Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Be able to understand informed consent form, voluntarily participate and sign informed consent form.\n2. Age ≥18 year (at the time consent is obtained), male or female.\n3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Has a Life expectancy ≥3 months.\n5. Has a pathologically documented advanced\u002Funresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.\n6. Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Must have adequate organ function prior to the start of JSKN033.\n8. Negative urine\u002Fserum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.\n\nExclusion Criteria:\n\n1. Has clinically active brain metastases.\n2. Previously received any other investigational drug within 28 days prior to enrollment.\n3. Previously received local palliative treatment within 14 days prior to enrollment.\n4. Previously received major surgeries within 28 days prior to enrollment.\n5. Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.\n6. Previously received live vaccine within 28 days prior to enrollment.\n7. Previously received antibody conjugate drug with topoisomerase I inhibitor.\n8. Has a history of other primary malignant tumors within 5 years prior to enrollment.\n9. Has uncontrolled comorbidities as specified by the protocol.\n10. Has a history of interstitial pneumonia\u002Flung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia\u002Flung disease that cannot be ruled out by imaging during screening period.\n11. Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.\n12. Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.\n13. Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.\n14. Has a history of allogeneic bone marrow or organ transplantation.\n15. Pregnant or breastfeeding female patients.\n16. Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.",{"count":254,"type":20},430,[23,129],"This is a phase I\u002FII multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced\u002Fmetastatic solid tumors.",[26],"2025-01-07",{"date":260,"type":42},"2025-01-13",{"date":237,"type":20},{"date":263,"type":20},"2027-12-31",{"name":265,"class":49},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":97},"100569216","phase-1-ak137-bispecific-antibody-targeting-cd73-and-lag-3-in-patients-with-advanced-malignant-tumors-100569216","NCT06691360","AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors","A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Written and signed informed consent.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n3. Life expectancy ≥3 months.\n4. Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.\n5. Subject must have at least one measurable lesion according to RECIST Version1.1.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.\n2. Receipt of any anti-CD73, anti-LAG-3 treatment.\n3. Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.\n4. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion\u002Fexclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).\n5. Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.\n6. History of organ transplant.\n7. Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.",{"count":274,"type":20},87,[23],"A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant tumors.",[26],"2024-11-14",{"date":280,"type":42},"2024-11-15",{"date":282,"type":20},"2024-12",{"date":284,"type":20},"2027-08",{"name":220,"class":49},{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":97},"100506710","phase-1-a-study-of-nbl-020-injection-in-subjects-with-advanced-malignant-tumors-100506710","NCT05877924","A Study of NBL-020 Injection in Subjects With Advanced Malignant Tumors.","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Anti-tumor Activity of NBL-020 Injection in Subjects With Advanced Malignant Tumors.","Inclusion Criteria:\n\n1. Those who are 18 years old or older (based on the date of signing the informed consent form) and voluntarily sign the informed consent form;\n2. For malignant tumors confirmed by histology or cytology, only solid tumor subjects were included in dose escalation study. In addition to solid tumors, additional skin T-cell lymphoma subjects could be considered in dose expansion study;\n3. Must be willing to provide tumor tissue samples that can meet the requirements of biomarker testing (fresh biopsy tissue is preferred; if fresh tissue cannot be provided, tumor tissue samples within 2 years can be provided), and tumor samples will be tested by the central laboratory. If tumor tissue does not meet the testing requirements, additional biopsy may be required;\n4. If the standard treatment fails or toxicity is intolerable, or there is no standard treatment, the enrolled subjects must fully recover from previous treatment, with an AE level of 0-1 (except for alopecia, pigmentation, or other toxicity that the researcher believes is not a safety risk to the subjects);\n5. For subjects with solid tumor, there is at least one measurable lesion that meets the RECIST 1.1 standard at the baseline (the measurable lesion area has not received radiotherapy in the past, or there is evidence that the lesion has unequivocal progressed after radiotherapy);\n6. ECOG PS score 0-1 points;\n7. Expected survival time ≥ 3 months (12 weeks);\n8. Good organ function (no blood transfusion or growth factor support treatment received within 2 weeks before blood collection for relevant examinations), including:\n\n   1. Absolute value of neutrophils (ANC) ≥ 1.5 × 10\\^9\u002FL；\n   2. Hemoglobin (Hb) ≥ 90 g\u002FL;\n   3. Platelets ≥ 100 × 10\\^9 \u002FL;\n   4. Creatinine ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥ 50 mL\u002Fmin (Cockcroft Fault formula);\n   5. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome）;\n   6. Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver metastasis);\n   7. Coagulation function: activated partial thromboplastin time(APTT), international standardized ratio (INR) ≤ 1.5 × ULN.\n\n   Note: If the subject does not meet the requirements during screening, a re-examination is allowed.\n9. The subjects must agree to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last administration. Women of childbearing age tested negative for serum pregnancy within 7 days before the first dose of the investigational drug.\n\nExclusion Criteria:\n\n1. Subjects with a history of severe allergies to monoclonal antibodies;\n2. Active pia mater lesions or uncontrolled brain metastases exist. Subjects with suspected or confirmed brain metastasis can be enrolled as long as they are asymptomatic and do not require treatment (such as radiotherapy, surgery, or corticosteroid therapy) to control the symptoms of brain metastasis. For subjects with brain metastasis requiring treatment, their symptoms remain stable (without hormone maintenance treatment, without symptoms of brain metastasis) for 2 weeks after treatment, and they can be enrolled.\n3. Subjects with active autoimmune diseases or a history of autoimmune diseases, but with the following diseases are allowed to be included in the study: well controlled type I diabetes, well controlled hypothyroidism only requiring hormone replacement treatment, skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia), or subjects who are expected to have no relapse under the condition of no external trigger factors;\n4. Having a history of primary immunodeficiency, a history of allogeneic organ transplantation, or a history of allogeneic hematopoietic stem cell transplantation;\n5. Chronic hepatitis B (HBsAg and\u002For HBcAb positive but HBV DNA\\\u003C2000 IU\u002FmL can be included), chronic hepatitis C (HCV antibody positive but HCV RNA negative can be included), and HIV antibody positive;\n6. The toxicity of previous anti-tumor treatments has not returned to ≤ Grade 1 (except for alopecia, pigmentation, or other toxicity that the researchers believe is not a safety risk to the subjects);\n7. Have a history of serious cardiovascular disease, including but not limited to:\n\n   1. Serious cardiac rhythm or conduction abnormalities, including but not limited to ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, within 6 months prior to the first dose of the investigational drug;\n   2. Have a history of myocardial infarction, unstable angina, angioplasty, or coronary artery bypass surgery within 6 months before the first dose of the experimental drug;\n   3. Heart failure, classified as Grade Ш or above by the New York Heart Association (NYHA);\n   4. Subjects with prolonged QT\u002FQTc interval in the screening period electrocardiogram);\n   5. During the screening, echocardiography showed left ventricular ejection fraction (LVEF)\\\u003C50%;\n   6. Poor control of hypertension (screening period systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg);\n8. Uncontrollable serous cavity effusion that requires frequent drainage or medical intervention (such as pleural effusion, abdominal effusion, pericardial effusion, etc., which requires additional intervention within 2 weeks after the intervention, excluding exfoliative cytology testing of the exudate) within 7 days before the first dose of the experimental drug;\n9. Severe or active infections (including tuberculosis infections) that require systemic antibacterial, antifungal, or antiviral treatment within 14 days before the first use of the experimental drug, except for subjects with viral hepatitis receiving antiviral treatment;\n10. Received any anti-tumor treatment (including chemotherapy, targeted therapy, immunotherapy, etc.) and any clinical research treatment within 4 weeks or 5 half-lives before the first administration (whichever is shorter);\n11. Have a history of (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid treatment, or currently have (non-infectious) pneumonia\u002Finterstitial lung disease requiring steroid treatment.\n12. Subjects are required to receive systemic corticosteroids (\\>10 mg daily prednisone or equivalent) or immunosuppressive therapy within 14 days before the first dose. Inhalation or local application of corticosteroids, adrenal hormone replacement therapy, and short-term (≤ 7 days) use of corticosteroids to prevent contrast agent allergies are allowed.\n13. History of immune related adverse events (immune-related AE) ≥ Grade 3 (CTCAE 5.0) after receiving immunotherapy;\n14. Previously received targeted TNFR2 treatment;\n15. Those who have undergone major surgery within 4 weeks before the first administration and have not yet fully recovered, or plan to undergo major surgery during the study period;\n16. Previous malignancies other than the disease under study within 3 years, except for those that can be cured through local treatment, such as skin basal cell carcinoma, cervical or breast cancer in situ;\n17. Pregnant or lactating women;\n18. Participate in another clinical study at the same time, unless it is an observational (non-intervention) clinical study or during the follow-up period of an intervention study;\n19. Has a clear history of neurological or mental disorders, including epilepsy or dementia;\n20. Other circumstances that researchers believe not suitable to participate in clinical trials, including but not limited to: subjects with severe or uncontrollable medical conditions, safety risks, interference with the interpretation of research results, and impact on trial compliance.",{"count":294,"type":20},200,[23],"This study aims to evaluate the safety and tolerability of NBL-020 injection in subjects with advanced malignant tumors, and determine the dose limiting toxicity (DLT), maximum tolerable dose (MTD) (if any), recommended phase II dose (RP2D), and dosing regimen of NBL-020.",[26],"2024-03-25",{"date":300,"type":42},"2024-03-26",{"date":302,"type":42},"2023-08-15",{"date":304,"type":20},"2026-12",{"name":306,"class":49},"NovaRock Biotherapeutics, Ltd",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":97},"100533286","phase-1-a-clinical-trial-to-evaluate-effect-of-iap0971-in-patients-with-advanced-malignant-tumors-100533286","NCT06223841","A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","A Clinical Trial of Phase Ib\u002FII to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n* 1\\. Age 18 to 75years, male or female.\n* 2\\. Phase Ib:With advanced or metastatic malignant solid tumor confirmed by histopathology, the standard treatment fails, or there is no standard treatment plan, or standard treatment is not applicable at this stage, or the patient refuses the standard treatment, or the investigator evaluates the patient who can benefit from this treatment.\n* 3.Phae II: Confirmed by histopathology that it is not feasible to perform complete resection and cannot be connected. Locally advanced (stage IIIB or IIIC) or metastatic (IV) after radical concurrent radiotherapy and chemotherapy Stage) non-small cell lung cancer (NSCLC). Note: For unacceptable radical synchronization\u002Fsequencing.Subjects with locally advanced stage IIIB\u002FIIIC of radiotherapy and chemotherapy need to be evaluated by relevant professional doctors. And provide written records to confirm.\n* 4.Phae II: Never received systemic anti-tumor therapy for locally advanced or metastatic NSCLC before. Tumor treatment(received adjuvant\u002Fneoadjuvant chemotherapy or radical treatment for locally advanced diseases) .Patients with synchronous or sequential radiotherapy and chemotherapy and disease progression occurred after the last treatment ≥6 months).\n* 5.Phase II: PD-L1 was positive (TPS≥50%) by IHC, and the patient was immunohistochemical. Epidermal growth factor receptor (EGFR) and anaplasticlymphomakinase (ALK) were negative.\n* 6\\. At least one measurable tumor lesion per RECIST 1.1 (solid tumors).\n* 7\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 7. The estimated survival time is ≥3 months.8.Adequate organ function: Hematological system (No blood transfusion or hematopoietic stimulating factor therapy within 14 days) Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL White blood cell count (WBC) ≥ 3.0 × 109\u002FL Platelets (PLT) ≥ 75 × 109\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Hepatic function Total bilirubin (TBIL) ≤ 3 × ULN Alanine aminotransferase (ALT) ≤ 3 × ULN; Aspartate aminotransferase (AST) ≤ 3 × ULN; Renal function Creatinine clearance (Ccr) (only calculated if creatinine \\> 3 × ULN) ≥ 50 mL\u002Fmin (calculated according to Cockcroft-Gault formula, see Appendix 7 for formula) Coagulation function Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 × ULN.\n* 8\\. Expected survival time of more than 3 months.\n* 9\\. Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partners during the trial and for at least 90 days after study drug administration; female patients of childbearing potential (see Appendix 8 for definition) must have a negative blood or urine pregnancy test 7 days before the first administration.\n* 10\\. Eligible patients with fertility (male and female) must agree that during and at the end of the trial.Use reliable contraceptive methods (hormones or screens) with their partners for at least 6 months after taking the drug.Obstacle law or abstinence); Blood of female patients of childbearing age within 7 days before the first use of the study drug.The pregnancy test must be negative.\n* 11.Subjects must be informed of the study prior to the trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1.Phase II: Pathohistologically confirmed with small cell lung cancer components, or sarcomatoid lesions.\n* 2\\. Phase II : Previous immunotherapy, including immune checkpoint inhibitors (such as PD-1\u002FPD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonist (such as:ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, etc.\n* 3\\. Phase Ib: Patients who received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, and other anti-tumor treatment within 4 weeks before the first administration, except for the following: Nitrosourea or mitomycin C was received within 6 weeks before the first administration; Oral fluoropyrimidines and small molecule targeted drugs within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to the first administration.Chinese proprietary medicines with anti-tumor indications were received within 2 weeks before the first administration.\n* 4\\. Receipt of other non-marketed investigational drugs or treatments within 4 weeks before the first administration.\n* 5\\. Patients who have received systemic glucocorticoids (prednisone \\> 10 mg\u002Fday or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days before the first administration; exclude the following conditions: topical, ophthalmic, intra-articular, intranasal or inhaled corticosteroid therapy; short-term use of glucocorticoid for preventive treatment (for example, prevention of contrast agent allergy).\n* 6.The adverse reactions of previous anti-tumor treatments have not recovered to CTCAE 5.0 grade evaluation ≤1 grade.Or the relevant provisions of the selection criteria (except for the toxicity that the researcher judges to have no safety risk).\n* 7\\. Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first administration, or require elective surgery during the trial.\n* 8.Previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* 9\\. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms.\n* 10\\. active infection and currently needs intravenous anti-infection treatment.\n* 11\\. immunodeficiency disease, including HIV antibody positive.\n* 12\\. Active hepatitis B (HBsAg positive and HBV-DNA positive or above normal) Limit), active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive Or greater than the upper limit of normal value).\n* 13.Vaccinated with any live vaccine within 4 weeks before the first use of the study drug.\n* 14\\. Hypersensitivity to any antibody drugs (NCI CTCAE 5.0 grade evaluation ≥3 Grade), or active ingredients or inactive excipients of research drugs and PD-1\u002FPD-L1 inhibitors.\n* 15.With serious and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease Etc.); Or other serious effects that may interfere with the detection or treatment of drug-related pulmonary toxicity. Moderate and severe lung diseases with respiratory function.\n* 16\\. History of serious cardiovascular and cerebrovascular diseases, including but not limited to: Patients with severe cardiac rhythm or conduction abnormalities, such as arrhythmia requiring clinical intervention, second-degree to third-degree atrioventricular block; QT interval (QTcF) corrected by Fridericia's method \\> 470 ms (see Appendix 9 for calculation formula); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade 3 and above cardiovascular and cerebrovascular events within 6 months prior to the first dose; Patients with heart failure with cardiac function class ≥ II according to New York Heart Association (NYHA) (see Appendix 4) or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%; Clinically uncontrolled hypertension.\n* 17\\. Patients who currently have active or have had autoimmune diseases that may have recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid diseases, type I Diabetics.\n* 18\\. Suffering from other malignant tumors within 5 years before the start of drug administration, except for the following cases: Malignant tumor that can be expected to be cured after treatment (including but not limited to fully treated thyroid gland) cervical carcinoma in situ, basal or squamous cell skin cancer or breast treated by radical surgery. Ductal carcinoma in situ, etc.).\n* 19\\. Clinically uncontrolled effusion in the third space, which is not suitable for enrollment based on the investigator's judgment.\n* 20\\. Known alcohol or drug dependence.\n* 21\\. Patients with mental disorders or poor compliance.\n* 22\\. Women who are pregnant or breastfeeding.\n* 23\\. The subject has a history of other serious systemic diseases or other reasons that make the subject unsuitable for this clinical study in the opinion of the investigator.",{"count":315,"type":20},50,[23,129],"This is a Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.",[26],"2024-02-18",{"date":321,"type":42},"2024-02-20",{"date":323,"type":20},"2024-03-01",{"date":325,"type":20},"2027-03-01",{"name":245,"class":49},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":4},"100533480","phase-1-phase-i-study-of-lnf1901-in-advanced-malignant-tumors-100533480","NCT06226363","Phase I Study of LNF1901 in Advanced Malignant Tumors","Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Initial Efficacy of LNF1901 in Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Male or female ≥18 years of age;\n2. Patients with advanced malignant tumors who have been confirmed histologically or cytologically and have failed to receive standard therapy, or cannot tolerate standard therapy, or cannot receive standard therapy for other reasons;\n3. Participants enrolled in the dose expansion phase had at least one measurable lesion; (4) Those who adopted the United States Eastern Oncology Consortium (ECOG) physical status score of 0\\~1;\n\n5\\) The researchers judged that the expected life of the subjects was ≥3 months; 6) The function of vital organs meets the following requirements (drugs with blood components and cytokines are not allowed to be used within 14 days before the first administration) : Blood routine: Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelet count ≥80×109\u002FL; Hemoglobin (Hb) ≥90g\u002FL; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, serum total bilirubin (TBIL) ≤1.5×ULN; If liver metastasis exists, AST and ALT≤5×ULN, TBIL≤1.5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin (Cr \\> 1.5×ULN); Coagulation function: International Normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN; Thyroid function: Thyroid stimulating hormone (TSH) within the normal range or free triiodothyronine (FT3), free thyroxine (FT4) normal or abnormal without clinical significance; 7) Subjects voluntarily participate in the study and sign the informed consent after receiving full informed consent.\n\nExclusion Criteria:\n\n1. Those who have previously received antibody treatment with any tumor necrosis factor receptor (TNFR) superfamily agonists, such as CD40, OX40, CD137, CD27, CD357, etc.;\n2. Those who have received anti-tumor therapy 4 weeks before the first administration or within 5 half-lives of the drug (whichever is shorter);\n3. Chronic systemic glucocorticoid therapy within 2 weeks prior to initial administration (daily dose equivalent to prednisone \\> 10mg of systemic corticosteroids) or any other form of immunosuppressive therapy;\n4. The toxicity of previous anti-tumor therapy has not returned to CTCAE5.0 version of the definition ≤ Class 1 (except hair loss);\n5. A history of cancer within the past 5 years, except for locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix);\n6. Patients with primary central nervous system (CNS) malignancies, CNS metastases after local treatment failure, and cancerous meningitis; Patients with asymptomatic brain metastases or stable neurological symptoms without steroid hormones or other BMS for ≥4 weeks could be enrolled.\n7. Patients with a history of organ transplantation or allogeneic bone marrow transplantation or who have received autologous stem cell transplantation within 3 months before the first administration of the drug;\n8. Those who have undergone major surgery or have not recovered from surgery within 4 weeks prior to the first dosing (except for diagnostic surgery);\n9. Physical examination or laboratory examination, any of the following conditions:\n\n   Hepatitis B: HBsAg positive and\u002For HBcAb positive with HBV-DNA titers positive or higher than the upper limit of normal (excluded if only the lower limit of detection is present); Hepatitis C: HCV antibody positive and HCV-RNA positive or greater than the upper limit of normal; Human immunodeficiency virus (Anti-HIV) positive; active treponema pallidum infection;\n10. Uncontrolled or severe cardiovascular disease, such as New York Heart Association (NYHA) Class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular disease, poorly controlled arrhythmias, within 6 months before the first administration of the drug. Difficult to control hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥100mmHg after adequate treatment);\n11. Patients with a history of the following, including but not limited to active autoimmune diseases, active infections (such as active tuberculosis), severe mental illness, and severe endocrine disorders;\n12. Patients who have been treated with any other investigational drug\u002Fdevice within 4 weeks prior to initial administration;\n13. Have a history of drug abuse or alcoholism within 6 months before the first dose;\n14. Have a history of severe allergy, and known subjects are previously allergic to macromolecular protein preparations\u002Fmonoclonal antibodies and to any investigational drug components;\n15. Those who received live or attenuated vaccine within 4 weeks before the first dose or planned to receive live or attenuated vaccine during the study period;\n16. Pregnant or lactating women, female subjects of childbearing age, or male subjects whose partners are women of childbearing age who do not consent to the use of medically approved effective contraceptive methods (such as Iuds or condoms) during the study period and within 6 months after the last study drug treatment;\n17. Those who were judged not suitable for inclusion by the researchers.",{"count":335,"type":20},82,[23],"This is a multicenter, open, phase I dose-escalation and dose-expansion study to evaluate the safety, tolerability, initial antitumor efficacy, PK and immunogenic characteristics of LNF1901 in patients with advanced malignancies.",[26],"2024-01-17",{"date":341,"type":42},"2024-01-26",{"date":343,"type":20},"2024-02-01",{"date":345,"type":20},"2027-02-01",{"name":347,"class":49},"Shandong New Time Pharmaceutical Co., LTD"]