[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biotech Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":184},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,63,86,110,135,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100637957","phase-1-jh021-in-patients-with-advanced-solid-tumors-or-egfr-mutant-nsclc-100637957",false,"NCT07582822","JH021 in Patients With Advanced Solid Tumors or EGFR-Mutant NSCLC","An Open-label, Multicenter Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of JH021 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 75 years, inclusive.\n2. Histologically or cytologically confirmed malignancy with disease progression since the most recent antitumor therapy, and for whom standard treatment is unavailable, not tolerated, or refused.\n\n   Part Ia: patients with advanced solid tumors. Part Ib: patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations (EGFR exon 19 deletion or exon 21 L858R) detected in tumor tissue or plasma ctDNA, who are resistant to third-generation EGFR-TKIs and have progressed after platinum-containing chemotherapy, or have no standard treatment available.\n3. At least one measurable lesion according to RECIST version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Estimated life expectancy of at least 12 weeks.\n6. Adequate organ function, defined as follows:\n\n   Bone marrow function:\n\n   Absolute neutrophil count \\>= 1.5 × 10\\^9\u002FL Platelet count \\>= 100 × 10\\^9\u002FL Hemoglobin \\>= 90 g\u002FL, without transfusion, erythropoietin, granulocyte colony-stimulating factor, hepatoprotective therapy, or other medical supportive treatment within 2 weeks before dosing\n\n   Hepatic function:\n\n   Total bilirubin \\\u003C= 1.5 × upper limit of normal (ULN) ALT and AST \\\u003C= 3 × ULN\n\n   For participants with liver metastases:\n\n   Total bilirubin \\\u003C= 2.5 × ULN ALT and AST \\\u003C= 5 × ULN\n\n   Renal function:\n\n   Serum creatinine \\\u003C= 1.5 × ULN or creatinine clearance \\>= 60 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n\n   Coagulation function:\n\n   INR \\\u003C= 1.5 × ULN PT \\\u003C= 1.5 × ULN APTT \\\u003C= 1.5 × ULN Fibrinogen \\>= 0.75 × lower limit of normal\n7. Women of childbearing potential and their partners must be willing to use effective contraception.\n8. Women of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 72 hours before first dose. Women are considered not of childbearing potential if they are postmenopausal for at least 12 months or have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation.\n9. Participants must be able to understand and comply with study procedures, voluntarily participate in the study, and sign written informed consent.\n\nExclusion Criteria:\n\n1. Known symptomatic or untreated central nervous system metastases, including leptomeningeal metastases. The following are allowed:\n\n   lesions stable for at least 4 weeks after radiotherapy before first dose, as confirmed by MRI\u002FCT; no uncontrolled neurological symptoms or signs, such as seizures, headache, central nausea\u002Fvomiting, progressive neurological dysfunction, or papilledema; asymptomatic untreated brain metastases not requiring local treatment (such as radiotherapy) or systemic treatment (such as mannitol or corticosteroids).\n2. History of another malignancy within 5 years before first dose, except for malignancies treated curatively with no recurrence, including non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or lobular carcinoma in situ of the breast, and localized prostate cancer.\n3. Receipt of chemotherapy, targeted therapy, or other systemic antitumor therapy within 4 weeks or 5 half-lives before first dose, whichever is shorter; or receipt of Chinese herbal medicine or Chinese patent medicine for antitumor treatment within 2 weeks before first dose.\n4. Continuous systemic treatment with corticosteroids at a dose \\>10 mg\u002Fday prednisone equivalent or other immunosuppressive therapy within 14 days before first dose or during the study. Exceptions:\n\n   inhaled or topical corticosteroids at \\\u003C=10 mg\u002Fday prednisone equivalent in the absence of active autoimmune disease; short-term corticosteroids \\>10 mg\u002Fday prednisone equivalent for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reaction after allergen exposure).\n5. Major surgery or radical radiotherapy within 4 weeks before first dose; palliative radiotherapy within 2 weeks before first dose; or therapeutic radiopharmaceuticals (e.g., strontium, samarium) within 8 weeks before first dose.\n6. Active infection requiring systemic treatment within 2 weeks before first dose, including active tuberculosis or pneumonia of any grade.\n7. Known interstitial lung disease.\n8. Known HIV antibody positivity; active hepatitis B virus infection (participants with positive HBsAg require HBV-DNA testing and are excluded if HBV-DNA is positive); active hepatitis C virus infection (positive HCV antibody and positive HCV-RNA); or positive syphilis antibody test.\n9. Toxicities from prior antitumor therapy that have not recovered to \\\u003C= Grade 1 according to NCI-CTCAE v6.0, except alopecia, Grade 2 hypoparathyroidism, laboratory abnormalities allowed by the inclusion criteria, or toxicities considered by the investigator to pose no safety risk.\n10. Severe concomitant diseases, including active gastrointestinal bleeding, intestinal obstruction, paralytic ileus, glaucoma, uncontrolled diabetes mellitus, or other serious medical conditions.\n11. Deep vein thrombosis.\n12. Pleural effusion, pericardial effusion, or ascites that cannot be controlled with appropriate intervention within 4 weeks before first dose. Small effusions detectable only by imaging are allowed.\n13. Major cardiovascular disease within 6 months before first dose, including severe arrhythmia, acute myocardial ischemia, unstable angina, congestive heart failure (New York Heart Association class \\>=2), left ventricular ejection fraction \\\u003C50%, history of long QT syndrome or confirmed family history of long QT syndrome, or QTcF \\>450 msec in males or \\>470 msec in females.\n14. Hypertension not controlled by standard treatment (systolic blood pressure \\>=140 mmHg and\u002For diastolic blood pressure \\>=90 mmHg).\n15. Cerebrovascular accident within 6 months before first dose, including transient ischemic attack or stroke.\n16. History of peripheral neuropathy of Grade 2 or higher.\n17. Known history of alcohol abuse or drug abuse, except for those who have stopped drinking alcohol.\n18. Prior organ transplantation.\n19. Pregnant or breastfeeding women, women planning pregnancy, women of childbearing potential not using reliable contraception, sexually active men unwilling to use contraception during the study and for 3 months after the last dose, or men planning to donate sperm during this period.\n20. Any medical, psychiatric, or other condition or circumstance that, in the investigator's opinion, may negatively affect participant safety or the reliability of study data.\n21. Known allergy or hypersensitivity to any component of the JH021 formulation.\n22. Prior treatment with EGFR monoclonal antibodies, c-MET monoclonal antibodies, c-MET antibody-drug conjugates, c-MET small-molecule TKIs, or EGFR\u002Fc-MET bispecific antibodies.","ALL","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is an open-label, multicenter Phase I study designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of JH021 injection in patients with advanced solid tumors. JH021 is a bispecific monoclonal antibody targeting EGFR and cMET. The study will assess JH021 in patients with advanced solid tumors for whom standard therapy is unavailable, intolerable, or no longer effective, and will provide data to support further clinical development.",[27],"Advanced Solid Tumor","NOT_YET_RECRUITING","2026-05-06",{"date":31,"type":32},"2026-05-13","ACTUAL",{"date":34,"type":21},"2026-05-30",{"date":36,"type":21},"2028-12-30",{"name":38,"class":39},"Biotech Pharmaceutical Co., Ltd.","OTHER",11,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":4},"100632219","phase-1-jy016-injection-in-patients-with-advanced-solid-tumors-expressing-egfr-100632219","NCT07510841","JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR","A Phase I\u002FII Clinical Study on the Safety, Pharmacokinetic Characteristics and Preliminary Efficacy of JY016 Injection in Patients With Advanced Solid Tumors Expressing EGFR","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years and ≤ 75 years;\n* 2\\. Tumor diagnosis and previous anti-tumor treatment: Phase I dose escalation stage: Subjects with advanced solid tumors with EGFR expression (immunohistochemistry 1+, 2+ or 3+) who have undergone standard treatment failure, or lack effective treatment options, or are unable to tolerate standard treatment, diagnosed by histological or cytological methods; Phase II expansion stage: Several tumor types with confirmed EGFR expression (initially determined as immunohistochemistry 1+, 2+ or 3+, and can be adjusted based on the exploratory results of EGFR expression in the dose escalation stage) confirmed by the central laboratory.\n* 3\\. ECOG physical condition score is 0-1 point;\n* 4\\. Expected survival exceeds 12 weeks;\n* 5\\. The bone marrow reserve and organ function levels must meet the following requirements 4 weeks before the first administration:(1) Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; platelet count ≥ 100 × 109\u002FL; hemoglobin ≥ 90 g\u002FL; (no blood transfusion or hematopoietic stimulating factor treatment within 14 days before the first administration);(2) Liver and kidney function: serum total bilirubin (TBIL) ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN; creatinine clearance rate ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula) or serum creatinine ≤ 1.5 × ULN;(3) Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5 × upper limit of normal; international normalized ratio (INR) ≤ 1.5 × ULN;(4) Cardiac function: cardiac ultrasound examination, left ventricular ejection fraction ≥ 50%; QT interval (QTcF) ≤ 450 milliseconds.\n* 6\\. At least one measurable lesion defined by RECIST v1.1 must exist at the baseline period;\n* 7\\. Reproductive-capable subjects (male and female) must agree to use reliable contraceptive methods (hormonal or barrier methods or abstinence) with their partners during the trial period and for at least 3 months after the last administration; for pregnant women of childbearing age, a negative blood pregnancy test must be obtained within 14 days before the first use of the trial drug.\n* 8.I have fully understood this study and voluntarily signed the informed consent form, willing and able to follow the research procedures.\n\nExclusion Criteria:\n\n* 1\\. The time interval between the last anti-tumor treatment and the first administration: for cytotoxic drugs and small molecule targeted drugs, ≤ 3 weeks; for large molecule monoclonal antibodies, ≤ 4 weeks; for radiotherapy (except for local radiotherapy for relieving pain) ≤ 4 weeks; for traditional Chinese medicine with anti-tumor indications approved by NMPA, ≤ 2 weeks;\n* 2\\. Known to be allergic to injectable JY016 or any of its excipient components; or having a history of allergy to drugs containing monoclonal components; other drug-induced liver toxicity or allergy history; or having a specific allergic reaction history (asthma, rubella, eczematous dermatitis); the subjects who have undergone previous anti-tumor treatment with central nervous system metastasis cancer, cancerous meningitis, or other central nervous system diseases or abnormalities;\n* 3\\. Have received targeted CD3 drug treatment before;\n* 4\\. Known to have central nervous system metastatic cancer, cancerous meningitis, or other central nervous system diseases or abnormalities;\n* 5\\. Human immunodeficiency virus (HIV) antibody positive, syphilis antibody positive or having other acquired or congenital immune deficiency diseases; active hepatitis C, antibody positive and HCV RNA test positive; active hepatitis B, for HBsAg positive, HBV DNA needs to be detected, and HBV DNA is higher than the upper limit of the normal value;\n* 6\\. Have received any anti-tumor treatment that was effective through T-cell recruitment therapy before, including but not limited to CAR-T and other in vitro cell therapies, CD3+ monoclonal antibodies, CD3+ dual antibodies, etc.;\n* 7\\. Have had a subject who experienced cytokine release syndrome (CRS) after any treatment;\n* 8\\. Have had anti-tumor treatment-related toxicity that has not been relieved to grade 1 or below (CTCAE v5.0) (excluding alopecia, pigmentation, and other toxicities determined by the investigator not affecting the safety of the study drug);\n* 9\\. Have other malignant tumors (excluding skin basal cell carcinoma and carcinoma in situ that underwent radical treatment and no disease recurrence within 5 years before screening);\n* 10\\. Have used other clinical trial test drugs within 4 weeks before the first administration of the test drug;\n* 11\\. Have used live virus vaccines within 4 weeks before the first administration of the test drug or during the expected study period, and within 4 weeks after the expected cessation of the study treatment;\n* 12\\. Have had active or requiring treatment bacterial, viral or fungal infections within 4 weeks before the first administration of the test drug;\n* 13\\. History of active tuberculosis;\n* 14\\. Have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n* 15\\. Have active autoimmune diseases (including but not limited to immune-related myocarditis, immune-related pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, multiple sclerosis, vasculitis or glomerulonephritis, etc.) within 1 year of receiving systemic treatment;\n* 16\\. Have undergone major organ surgery (excluding biopsy and minimally invasive surgeries that have recovered well) or had significant trauma within 4 weeks before the first administration of the test drug, or need to undergo elective surgery during the study period;\n* 17\\. Have had severe non-healing wounds\u002Fulcers\u002Ffractures within 4 weeks before the first administration of the test drug;\n* 18\\. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to: 1) Severe cardiac rhythm or conduction abnormalities; 2) Congestive heart failure (NYHA classification ≥ III); 3) Acute coronary syndrome, aortic dissection, stroke or other grade 3 or above cardiovascular events within 6 months before the first administration;\n* 19\\. Uncontrolled third space effusion (pleural effusion, pericardial effusion or abdominal effusion, etc.);\n* 20\\. Known to have a history of drug abuse;\n* 21\\. Pregnant or lactating women;\n* 22.The investigator believes that the subject has other systemic diseases or other reasons that make them unsuitable to participate in this clinical study.",{"count":49,"type":21},228,[24,51],"PHASE2","This study is a single-arm, open-label, multi-center Phase I\u002FII clinical trial, consisting of Part A: the Phase I dose escalation stage, and Part B: the Phase II expansion stage. The objective of the Phase I dose escalation stage is to evaluate the safety, pharmacokinetic characteristics, and preliminary efficacy of JY016 injection in patients with advanced solid tumors expressing EGFR (immunohistochemistry 1+, 2+, or 3+). In the Phase II stage, the efficacy of JY016 in pancreatic cancer, non-small cell lung cancer, esophageal cancer, colorectal cancer, and squamous cell carcinoma of the head and neck with EGFR expression will be further evaluated.",[54],"Solid Cancers","2026-03-31",{"date":57,"type":32},"2026-04-06",{"date":59,"type":21},"2026-04-30",{"date":61,"type":21},"2029-05-31",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":16,"minAge":17,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100624738","phase-1-a-phase-ia-single-ascending-dose-study-of-subcutaneous-eb070-injection-in-healthy-volunteers-100624738","NCT07413536","A Phase Ia Single Ascending-Dose Study of Subcutaneous EB070 Injection in Healthy Volunteers","A Phase Ia Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous EB070 Injection in Healthy Volunteers","Inclusion Criteria:\n\n* Age: 18 to 60 years old.\n* Sex: Healthy male and female participants.\n* Body weight: ≥50 kg for males and ≥45 kg for females; body mass index (BMI = weight \\[kg\\] \u002F height \\[m²\\]) between 18 and 26 kg\u002Fm².\n* Participants of reproductive potential (both male and female) must agree to use reliable contraception (hormonal, barrier method, or abstinence) during the study and for at least 3 months after study completion. Female participants of childbearing potential must have a negative pregnancy test (β-HCG) at screening and baseline and must not be breastfeeding.\n* Informed consent: Participants must have been adequately informed about the study, voluntarily sign the informed consent form, and be willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n* Abnormal findings at screening in physical examination, vital signs, 12-lead ECG, or laboratory tests (including hematology, urinalysis, blood biochemistry, coagulation function, and thyroid function) deemed clinically significant by the investigator.\n* Positive serology for any of the following: hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or HIV antigen\u002Fantibody.\n* History of any clinically significant disease affecting the respiratory, digestive, cardiovascular, hematologic\u002Flymphatic, nervous, psychiatric, genitourinary, endocrine, hepatic, renal, dermatologic, or metabolic systems, or any other condition that could interfere with study results.\n* Blood pressure at screening: systolic ≥140 mmHg or \\\u003C90 mmHg, or diastolic ≥90 mmHg or \\\u003C50 mmHg.\n* Planned major surgery during the study, or major surgery within 1 month prior to randomization.\n* History of chronic infection, particularly bacterial, viral, fungal, or parasitic infection within 1 month prior to randomization.\n* Known allergy to EB070 or any excipients, history of hypersensitivity to antibody-based biologics, or history of specific allergic conditions (e.g., allergic conjunctivitis, allergic asthma, atopic dermatitis), or any clinically significant food, drug, insect bite, foreign protein, or monoclonal antibody allergy as judged by the investigator.\n* Alcohol abuse: ≥28 standard drinks per week within 1 year prior to randomization, or frequent drinking (\\>14 standard drinks\u002Fweek) within 6 months prior to randomization; or failed breath alcohol test (\\>0 mg\u002F100 mL) at screening or Day 1. (One standard drink contains 14 g alcohol, e.g., 360 mL beer, 45 mL 40% liquor, or 150 mL wine.)\n* Smoking ≥5 cigarettes per day or equivalent tobacco use (e.g., nicotine gum\u002Flozenges) within 3 months prior to randomization, inability to abstain during the study, or positive urine cotinine test at screening or Day 1.\n* Participation in any clinical trial of an investigational drug within 3 months prior to randomization (or within 5 half-lives, whichever is longer).\n* Use of any medications or dietary supplements (prescription, over-the-counter, herbal, or traditional Chinese medicine) within 14 days prior to randomization, or within 5 half-lives of the study drug.\n* Use of any biologic products within 3 months prior to randomization (or within 5 half-lives, whichever is longer).\n* Administration of live or attenuated vaccines within 1 month prior to randomization or planned during the study.\n* History of substance abuse (e.g., morphine, cannabis, methamphetamine, MDMA, ketamine) within 1 year prior to randomization, or positive urine drug screen at screening or Day 1.\n* Blood donation or significant blood loss (≥400 mL) within 3 months prior to randomization, or planned donation during the study or within 3 months after study completion.\n* History of syncope or needle phobia, or inability to tolerate blood draws.\n* Positive interferon-gamma release assay (T-SPOT.TB). Subjects without tuberculosis history or symptoms may be included if results are within twice the upper limit of normal.\n* Any other condition that the investigator judges makes the participant unsuitable for the study.",true,"60 Years",{"count":73,"type":21},36,[24],"The goal of this Phase Ia clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of EB070 injection following single ascending subcutaneous doses in healthy adult volunteers.\n\nThe main questions it aims to answer are:\n\nIs EB070 injection safe and well tolerated at increasing single subcutaneous dose levels in healthy subjects?\n\nWhat are the pharmacokinetic characteristics of EB070 after single-dose administration?\n\nThis is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose (SAD) study. A total of 36 healthy volunteers will be enrolled and assigned to one of five dose cohorts (21 mg, 75 mg, 225 mg, 450 mg, or 600 mg). Subjects in each cohort will be randomized in a 3:1 ratio to receive a single subcutaneous injection of EB070 or placebo.\n\nA sentinel dosing strategy will be applied. In the 21 mg cohort, one subject will initially receive EB070. In the remaining cohorts, two sentinel subjects (one receiving EB070 and one receiving placebo) will be dosed first. Dose escalation and enrollment of the remaining subjects will proceed after evaluation of safety and tolerability within 48 hours after dosing.\n\nParticipants will:\n\nUndergo screening assessments prior to dosing\n\nReceive a single subcutaneous injection of EB070 or placebo\n\nStay in the Phase I unit for approximately 3 days for safety monitoring and pharmacokinetic and anti-drug antibody (ADA) sample collection\n\nReturn for scheduled outpatient visits for PK, ADA, and safety assessments through Day 113\n\nSafety will be assessed throughout the study by monitoring adverse events, vital signs, physical examinations, 12-lead ECGs, and laboratory tests. Pharmacokinetic parameters and anti-drug antibodies (ADA) will be evaluated as secondary outcomes.",[77],"Health Adult Subjects","2026-02-09",{"date":80,"type":32},"2026-02-17",{"date":82,"type":21},"2026-03",{"date":84,"type":21},"2027-03",{"name":38,"class":39},{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":70,"sex":16,"minAge":17,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100564736","phase-1-a-phase-i-clinical-trial-of-jh013-injection-100564736","NCT06633055","A Phase I Clinical Trial of JH013 Injection","A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JH013 Injection in Healthy Subjects","Inclusion Criteria:\n\n* Healthy adult male or female aged 18-55 years (age including cut-off values);\n* There were no abnormalities in clinically significant vital signs, physical examination, laboratory tests, and 12-lead ECG;\n* Weight ≥ 50 kg for males and ≥45 kg for females; Body mass index (BMI) between 18.0 and 26 kg\u002Fm2 (including cut-off values, body mass index = weight\u002Fheight2);\n* Females of potential childbearing potential with a negative blood β-HCG test within 72 hours prior to dosing (postmenopausal women who have amenorrhea for at least 12 months are considered non-childbearing and women who are known to have undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or ligation, and a pregnancy test is not required);\n* Subjects understand and comply with the study process, participate voluntarily, and sign the informed consent form\n\nExclusion Criteria:\n\n* Subject has a history of malignancy prior to screening, or has been screened for malignancy, and the possibility of malignancy cannot be reasonably ruled out\n* Subject has a history of autoimmune disease prior to screening\n* γ interferon release assay results ≥ 2 times the upper limit of normal\n* Any history of infection requiring hospitalization or receiving antivirals, antibiotics, antifungals, antiparasitic drugs, or vaccinations within 4 weeks prior to the application of the study drug\n* Those who have positive test results for human immunodeficiency virus (HIV) antibody, hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody or syphilis antibody\n* Patients with a history of previous and\u002For current heart disease (including New York Heart Association Class III\u002FIV heart failure), gastrointestinal, renal, endocrine, neurological, autoimmune, hematologic (including pancytopenia, aplastic anemia or anaemia, etc.), metabolic (including diabetes), severe lung disease and psychiatric illness\n* History of organ transplantation: such as heart, lung, kidney, liver, or hematopoietic stem cell transplantation","55 Years",{"count":95,"type":21},32,[24],"This is a phase I clinical trial with a single dose escalation to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JH013 injection in healthy subjects",[99],"Healthy Subjects (HS)",[101],"Dose escaltion","2024-10-07",{"date":104,"type":32},"2024-10-09",{"date":106,"type":21},"2024-10-31",{"date":108,"type":21},"2025-12-31",{"name":38,"class":39},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100514404","phase-3-nimotuzumab-combined-with-paclitaxel-for-recurrent-metastatic-gastric-or-esophagogastric-junction-adenocarcinoma-100514404","NCT05978050","Nimotuzumab Combined With Paclitaxel for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma","Nimotuzumab Combined With Paclitaxel as Second-line Treatment for Recurrent Metastatic Gastric or Esophagogastric Junction Adenocarcinoma With EGFR Over-expression: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial","NOTABLE-307","Inclusion Criteria:\n\n* 1\\. Age: 18-75 years old (including boundary value), male or female;\n* 2\\. The physical status score ECOG is 0-1;\n* 3\\. Histopathologically or cytologically confirmed gastric or esophagogastric junction adenocarcinoma;\n* 4\\. Recurrent metastatic disease, previous treatment with first-line standard chemotherapy regimens (including platinum-containing and\u002For fluorouracil regimens) (recurrence or metastasis during adjuvant therapy or within 6 months after completion is considered first-line therapy), or received anti-HER2 therapy, or received immunotherapy, and has been confirmed by the investigator or has a clear disease progression in the medical history;\n* 5\\. At least one evaluable tumor lesion according to the RECIST version 1.1 evaluation criteria;\n* 6\\. Detection of primary or metastatic lesions during the screening period (when multiple specimens exist at the same time, the bulk specimen is preferred over the biopsy specimen, and the metastasis is preferred over the primary lesion) tissue is determined to be EGFR high expression (IHC2+ or IHC3+);\n* 7\\. Estimated survival≥ 12 weeks;\n* 8\\. Have proper organ function, defined as:Total bilirubin ≤ 1.5 times the upper normal limit (ULN); glutamyltransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN in the absence of liver metastases; ALT or AST ≤ 5 times ULN in the presence of liver metastases;Serum creatinine level≤ 1.5 times ULN; neutrophil count ≥1.5×109\u002FL; WBC count≥ 3.0×109\u002FL; platelets≥ 100×109\u002FL; Hemoglobin≥ 90g\u002FL;\n* 9\\. Patients of childbearing age and their spouses are willing to use contraception;\n* 10\\. Women of potential fertility have negative serum hCG within 72 hours prior to randomization (postmenopausal women with amenorrhea for at least 12 months are considered infertile, and women who are known to have undergone tubal ligation are not required to undergo a pregnancy test);\n* 11\\. The subject understands and complies with the study process, voluntarily participates, and signs the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Received the following treatments before this study:\n\n  1. The disease has progressed after previous paclitaxel chemotherapy or molecular targeted drug (anti-EGFR antibody) treatment, or received paclitaxel chemotherapy or molecular targeted drug (anti-EGFR antibody) treatment within 4 weeks before randomization;\n  2. Within 4 weeks before randomization or participating in other therapeutic\u002Fintervention clinical trials or receiving combined treatment prohibited by the protocol;\n* 2\\. Received major surgical treatment, incision biopsy (such as laparotomy) or obvious traumatic injury within 4 weeks before randomization;\n* 3\\. Brain metastases or meningeal metastases;\n* 4\\. Has a history of malignant tumors other than gastric adenocarcinoma or esophagogastric junction adenocarcinoma (except for cured cervical carcinoma in situ or skin basal cell carcinoma and other malignant tumors that have been cured for 5 years);\n* 5\\. Known to have suffered from severe bleeding disorders (such as severe gastrointestinal bleeding) and vasculitis within 3 months before randomization;\n* 6\\. Known to be accompanied by other serious diseases, including but not limited to:\n\n  1. Refractory congestive heart failure (NYHA classification III or IV, see Appendix 2), unstable angina, poorly controlled arrhythmia, uncontrolled moderate or high blood pressure (SBP\\>160mmHg or DBP\\>100mmHg );\n  2. Uncontrolled diabetes;\n  3. Mental illness that affects informed consent and\u002For protocol compliance;\n  4. There are serious diseases that other researchers believe are not suitable for participating in this study;\n* 7\\. Known allergies or contraindications to anti-EGFR antibody preparations, paclitaxel and other components;\n* 8\\. Patients who have previously used immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), such as the following adverse events related to immune checkpoint inhibitors and have not recovered to grade 1 And below, not suitable for inclusion: Grade ≥3 ocular adverse events, abnormal liver function in line with Hy's Law standard adverse events, ≥3 neurological toxicity, ≥3 grade colitis, ≥3 grade renal toxicity;\n* 9\\. Those who are known to have third space effusion (including a large amount of pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n* 10\\. Known NCI CTC grade 2-4 peripheral neuropathy;\n* 11\\. Known history of primary or secondary immunodeficiency or current active primary or secondary immunodeficiency;\n* 12\\. Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA ≥ 1000 IU\u002Fml or hepatitis C virus (HCV) RNA positive (inactive hepatitis B surface antigen carriers, treated And stable hepatitis B patients \\[HBV DNA \\\u003C1000 IU\u002Fml and cured hepatitis C patients can be selected\\]); Treponema pallidum antibody positive or human immunodeficiency virus antibody positive or any uncontrolled infection By;\n* 13\\. Women of childbearing age who are pregnant, breast-feeding, planning to become pregnant, or who have not taken reliable birth control measures and men in the sexually active period who are unwilling to take birth control measures during the study period and within 3 months after the last medication, and during the above-mentioned specified time Sperm donors;\n* 14\\. Any medical, psychiatric or other condition or situation that the investigator believes that the subject's participation in this clinical research may have a negative impact on the safety of the subject or the reliability of the research data.",{"count":119,"type":21},354,[121],"PHASE3","In order to evaluate the efficacy and safety of nimotuzumab combined with paclitaxel as second-line treatment for recurrent metastatic gastric or esophagogastric junction adenocarcinoma with EGFR over-expression, investigators performed a randomized, double-blind, placebo-controlled phase III clinical trial. Patients will be randomized (1:1) to receive nimotuzumab plus paclitaxel in the experimental group and placebo plus paclitaxel in the control group. The primary endpoint of this study was OS, and according to the results of the RAINBOW-Asia gastric cancer phase III clinical study, the mOS of paclitaxel single-agent second-line treatment for gastric cancer was 7.92 months, assuming that the mOS increased to 10.92 months after the addition of nimotuzumab, Using the survival module in the PASS15 software, the two-sided test level was set α=0.05, β=0.20, enrolled for 2 years, followed up for 1.5 years, the dropout rate was 5%, the sample size including interim analysis was 354 cases. The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR), patient reported outcome (PRO), and safety.",[124],"Gastric or Esophagogastric Junction Adenocarcinoma","RECRUITING","2024-08-27",{"date":128,"type":32},"2024-08-28",{"date":130,"type":32},"2024-08-01",{"date":132,"type":21},"2026-03-01",{"name":38,"class":39},1,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100542457","phase-3-nimotuzumab-combined-with-trifluridinetipiracil-in-the-treatment-of-refractory-metastatic-colorectal-cancer-100542457","NCT06343116","Nimotuzumab Combined With Trifluridine\u002FTipiracil in the Treatment of Refractory Metastatic Colorectal Cancer","Randomized Double-blind, Placebo-controlled, Multicenter Clinical Study of Nimotuzumab Combined With Trifluridine\u002FTipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer","NOTABLE-308","Inclusion Criteria:\n\n1. Age 18-75 years old, gender unlimited;\n2. Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC);\n3. Metastatic colorectal cancer, disease progression after previous second-line or above standard therapy;\n4. Efficacy of previous line therapy containing an anti-EGFR agent (panitumumab or cetuximab) with complete or partial response, or disease stable; and more than 4 months from last dose of anti-EGFR agent administered before randomization;\n5. MSS\u002FpMMR status detected by IHC or PCR;\n6. RAS and BRAF wild-type status;\n7. ECOG Performance Status 0-1;\n8. Measurable disease according to RECIST criteria v1.1;\n9. Life expectancy of at least 3 months;\n10. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g\u002FdL; absolute neutrophil count (ANC)≥1.5×10\\^9\u002FL; white Blood Cell Count≥4×10\\^9\u002FL;platelets≥100×10\\^9\u002FL; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases should be ≤ 5 times the ULN; serum creatinine≤1.5×ULN or estimated creatinine clearance \\> 60 mL\u002Fmin;\n11. Women of childbearing age should have a negative result of serum HCG or urine pregnancy tests within 72 hours prior to randomization (Postmenopausal women who have had amenorrhea for at least 12 months are considered sterile and women known to have had tubal ligation are not required to undergo pregnancy tests) ;\n12. Good compliance and signed informed consent.\n\nExclusion Criteria:\n\n1. Had other malignancies within the past 5 years or at the same time (exceptions include: cured thyroid cancer, non-melanoma skin cancer, carcinoma in situ of the cervix, stage I ductal carcinoma in situ, stage I endometrial cancer or other solid tumors, and effectively treated lymphoma with no evidence of disease for more than 5 years);\n2. Has a serious underlying medical condition that makes it impossible to safely administer the trial treatment. Including but not limited to active infections requiring systemic medication: compensatory heart failure (NYHA grade III and IV), unstable angina, and acute myocardial infarction within 3 months prior to enrollment;\n3. Patients who received trifluridine\u002Ftipiracil or treated with EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor within four months;\n4. Known allergy to prescription or any component of the prescription used in this study;\n5. Women who are pregnant or are breastfeeding;\n6. Has brain metastases or any symptoms of brain metastases\n7. Factors that significantly affect oral drug absorption, such as dysphagia, chronic diarrhea, gastrointestinal obstruction, etc; Uncontrolled Crohn's disease or ulcerative colitis;\n8. Participated in other clinical trials within 4 weeks;\n9. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)\n10. Other reasons that are not suitable to participate in this study according to the researcher's judgment.",{"count":144,"type":21},420,[121],"This is a randomized, double-blind, placebo-controlled, multicenter study. The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridine\u002Ftipiracil in third-line and beyond for the treatment of metastatic colorectal cancer (mCRC). This study planned to be divided into two parts: Part A and Part B. Part A (safety run-in) with a 3 + 3 study design, which primary endpoint is safety; Part B (main study) with a prospective, randomized, double-blind, placebo-controlled design, which primary endpoint is overall survival (OS).",[148],"Refractory Metastatic Colorectal Cancer",[150,151,152],"Nimotuzumab","trifluridine\u002Ftipiracil","metastatic colorectal cancer","2024-03-26",{"date":155,"type":32},"2024-04-02",{"date":157,"type":21},"2024-04",{"date":159,"type":21},"2027-04",{"name":38,"class":39},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":168,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100541742","phase-3-a-study-of-nimotuzumab-plus-concurrent-chemoradiotherapy-sequential-maintenance-treatment-for-cervical-carcinoma-100541742","NCT06333821","A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma","A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1.Aged 18-80 years old;\n* 2.Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);\n* 3.At least one measurable lesion according to RECIST 1.1;\n* 4.Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria: Hemoglobin ≥ 90 g\u002FL; Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL and white blood cell count ≥ 3.0 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN ; Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;\n* 5.ECOG score 0-1 points;\n* 6.Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation); Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;\n* 7.Compliance is good and informed consent is voluntarily signed.\n\nExclusion Criteria:\n\n* 1.Cervical adenocarcinoma and rare pathological types of malignant tumors;\n* 2.Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;\n* 3.Ureteral obstruction, inability to place ureteral stent or pyelostomy;\n* 4.Pregnant or lactating women;\n* 5.Patients with rectovaginal fistula\u002Fvaginovesical fistula\u002Funcontrolled vaginal bleeding or at risk of fistula;\n* 6.Had undergone major surgery (except biopsy) within 4 weeks prior to randomization;\n* 7.Had received a live vaccine within 4 weeks prior to the initial study drug treatment or planned to vaccinate during the study;\n* 8.Human immunodeficiency virus (HIV) infection;Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);\n* 9.Had the following serious medical conditions: a) Uncontrolled hypertension (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg), or had experienced a hypertensive crisis; b) Myocardial infarction and unstable angina occurred within 6 months before randomization; c) Decompensated heart failure within three months before enrollment (NYHA class III and IV); d) The presence of severe arrhythmias requiring long-term medical intervention, except in patients with asymptomatic atrial fibrillation with stable ventricular rate; e) Left ventricular ejection fraction (LVEF)\\\u003C50%; f) The presence of uncontrolled hyperglycemia; g) The presence of uncontrollable infections；\n* 10.The presence of active or suspected autoimmune diseases, except for type 1 diabetes、hypothyroidism or skin conditions that do not require systemic treatment (vitiligo、psoriasis or alopecia)；\n* 11.Conditions requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days before randomization；\n* 12.Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);\n* 13.Patients with Crohn's disease and ulcerative colitis;\n* 14.Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;\n* 15.Patients with known hypersensitivity to Nimotuzumab or its components;\n* 16.Patients with contraindications to cisplatin、carboplatin and paclitaxel;\n* 17.Patients with neurological or psychiatric disorders affecting cognitive ability;\n* 18.Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;\n* 19.Any condition that, in the opinion of the Investigator, may be inappropriate for patients in the study.","FEMALE","80 Years",{"count":171,"type":21},460,[121],"The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.\n\nThe primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.",[175],"Cervical Cancer","2024-03-20",{"date":178,"type":32},"2024-03-27",{"date":180,"type":21},"2024-04-01",{"date":182,"type":21},"2030-04-01",{"name":38,"class":39},""]