[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Nutai Biologics Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100572669","early-phase-1-a-phase-i-study-on-evaluating-the-safety-tolerability-pharmacokinetic-characteristics-and-preliminary-efficacy-of-sxrn-plasmid-dna-technique-in-patients-with-advanced-solid-tumors-100572669",false,"NCT06736275","A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors","For Dose-Escalation Phase:\n\n* Inclusion Criteria:\n* male or female, aged 18\\~75 at the time of signing the ICF;\n* patient with advanced solid tumors who have failed\u002Fcannot tolerate previous standard therapies or lack conventional effective therapies;\n* at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* expected survival time ≥12 weeks;\n* lab results and organ function tested within 7 days before the initial infusion meet the criteria below:\n* Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL;2)Platlets (PLT) Count≥90×10\\^9\u002FL; 3)Hemoglobins (Hb) ≥90 g\u002FL.\n\nNote: the criteria above shall still be maintained within 14 days before the initial infusion, either without the need of blood transfusion, or using supportive treatment including granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11 (IL-11), and erythropoietin (EPO), and etc.\n\n* Blood biochemistry: 1)Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); 2)Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft Gault formula ≥50 mL\u002Fmin; 3)Aspartate Amino Transferase (AST), Alanine Aminotransferase (ALT) ≤2.5×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g\u002FL.\n* Urine protein ≤2+ (if \\>2+, urine protein shall be collected for 24 hours; total protein ≤1g is acceptable for inclusion).\n* International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.\n\nNote: for subjects receiving precautious anti-coagulation treatment, the investigator shall determine whether INR and APTT remains in a safe and effective range for treatment.\n\n* Left Ventricular Ejection Fraction (LVEF) ≥50%.\n* can understand and voluntarily sign the Informed Consent Form (ICF); must be voluntary and able to finish the study program and follow-up tests.\n\nExclusion Criteria:\n\n* Subjects who meet any of the criteria below must not be included:\n* has received any of the anti-tumor treatments below:a) received cytotoxic chemotherapy, tumor immunotherapy, anti-tumor biologics or other trail agents within 4 weeks or 5 half-times (whichever is shorter) before the initial infusion.b)received an oral small-molecule targeted anti-tumor agent within 2 weeks before the first infusion or for five half-lives(whichever was shorter).c) received anti-tumor Chinese patent medicine approved by NMPA within 2 weeks before the initial infusion.d) received more than 30% bone marrow radiotherapy or large area radiotherapy within 2 weeks before initial infusion (palliative radiotherapy at the bone or superficial lesions is acceptable).\n* participated in and received an investigational drug or device clinical trial within 4 weeks before initial infusion.\n* Patients who had undergone or planned to undergo major surgery or interventional therapy (excluding tumor biopsy, puncture, etc.) within 4 weeks before initial infusion.\n* unrecovered from the toxic reaction caused by previous anti-tumor treatment (not recovered to ≤ grade 1 or baseline; not including toxic reactions with no safety risk as determined by the investigator, such as alopecia, asymptomatic hypothyroidism caused by immune checkpoint inhibitors that can be treated with only thyroid hormone and remains stable, and etc.).\n* with clinically uncontrollable serous effusion (pleural effusion, ascites and pericardio effusion). Conditions may include: moderate or above sized effusion, received within 2 weeks before the selection or plans to receive local treatments (including drainage, peritoneal shunt, and cell-free concentrated ascites reinfusion, and etc.), or effusion obviously increased within 2 weeks after the local treatment and thus needs long-term catherterization. Candidates who meet any of the conditions above, or determined by the investigator as unsuitable, shall not be included.\n* with central nervous system metastasis and show relating symptoms.\n* with a history of other malignant tumors, except for those that have received radical surgery and not relapsed 5 years thereafter, such as carcinoma in situ of cervix, skin basal cell carcinoma, and etc.\n* with a history of immune deficiency diseases, including acquired or congenital immunodeficiency disorders; or a history of organ transplantation, heterogeneous bone marrow transplantation, or autologous hematopoietic stem cell transplantation.\n* had (non-infectious) lung inflammation \u002F interstitial lung disease that required steroid treatment within 4 weeks before the initial infusion.\n* with a history of severe cardiovascular and cerebrovascular diseases, including but not limited to:\n\n  1. severe abnormalty in cardiac rhythm or conduction, such as ventricular arrhythmia requiring clinical intervention, atrioventricular block of II\\~III grade, and etc.;\n  2. cardiac insufficiency of III\\~IV grade as defined by New York Heart Association(NYHA);\n  3. acute coronary syndrome, congestive cardiac failure, aortic dissection, cerebral stroke or other grade 3 or above cardio-cerebral vascular events within 6 months before the initial infusion.\n* with uncontrollable high blood pressure (systolic pressure ≥160 mmHg and\u002For diastolic pressure ≥100 mmHg) after treatment with anti-hypertensive drugs of stable doses.\n* with active chronic hepatitis B (such as, HbsAg or HbcAb positive and HBV DNA ≥ lower limit of detection, active hepatisis C (such as, HCV antibody positive and HCV RNA≥ lower limit of detection), or HIV infection.\n* with active infections within 2 weeks before the initial infusion that require systematic treatment.\n* with a history of active tuberculosis infection within 1 year before the initial infusion.\n* had or has uncontrollable or serious diseases that may interfere with the participation or evaluation in the study, as considered by the investigator;\n* known to be allergic or taking drugs contradictionary to the study drug (Suplussirna) or its excipients.\n* premenopause female candidates (postmenopausal female patients can only be considered infertilewhen they have been postmenopausal for at least 12 months) with positive results in serum pregnancy test; candidates of reproductive age (also including female spouse of reproductive age of male candidates), during the study or within 6 months after the last infusion, who will probably bear children, breastfeed, or are unwilling to cake effective contraceptives, as considered by the investigator.\n* other conditions that are determined by the investigator as unsitable for entering this trial.\n\nFor Expansion Cohort(Randomized, Double-blind, Placebo-controlled Part):\n\n* Inclusion Criteria:\n* Male or female, aged 18 to 75 years at time of signing ICF.\n* Histologically or cytologically confirmed solid tumor.\n* Patients who have failed standard therapy, lack standard therapy, or are in a treatment holiday period (4 weeks) without need for anti-tumor therapy.\n* Diagnosis of cancer anorexia-cachexia according to 2025 CSCO guideline, meeting either (①+②) or (①+③):\n\n  * Involuntary weight loss \\>5% in 6 months; OR weight loss \\>2% with BMI \\\u003C18.5 kg\u002Fm²; OR weight loss \\>2% with reduced muscle mass.\n\n    * Anorexia (VAS ≤70 or FAACT-A\u002FCS-12 score ≤37).\n\n      * CRP \\>5 mg\u002FL.\n* ECOG performance status 0-2.\n* Life expectancy ≥12 weeks.\n* Adequate organ function and laboratory parameters within 7 days prior to first study drug, meeting the same criteria as listed above for the dose-escalation phase (i.e., ANC, platelets, hemoglobin, liver\u002Fkidney function, coagulation, LVEF, etc.).\n* Same informed consent requirement as the dose-escalation phase: able to understand and voluntarily sign the ICF, and willing\u002Fable to complete study procedures and follow-up.\n\nExclusion Criteria:\n\nThe exclusion criteria are the same as those for the dose-escalation phase above, with the following additional or modified criteria:\n\n* Reversible causes of reduced food intake determined by investigator (e.g., mechanical obstruction preventing eating).\n* Use of any medication or therapy for cachexia, anorexia, or weight loss (excluding enteral nutrition support) within 28 days or 5 half-lives (whichever shorter) prior to first study drug, including but not limited to progestins (megestrol acetate, medroxyprogesterone acetate), corticosteroids, anamorelin, cannabinoids, androgens, NSAIDs.\n* Currently receiving tube feeding or parenteral nutrition.\n* Cachexia clearly due to other causes (e.g., severe COPD, AIDS).\n* Hormone therapy judged by investigator to improve cachexia.\n* Central nervous system metastases requiring intervention (instead of \"symptomatic CNS metastases\").\n* Known allergy or contraindication to SXRN or its process impurities (e.g., spectinomycin).\n* Note: For the expansion cohort, the washout period for other investigational drugs is \"4 weeks or 5 half-lives\" (same as dose-escalation phase), and all other exclusion criteria (prior anti-tumor treatments, unresolved toxicity, serous effusion, cardiovascular disease, infections, etc.) apply identically as listed above.","ALL","18 Years","75 Years",{"count":19,"type":20},28,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.",[26,27],"Advanced Cancer","Cachexia",[29],"micoRNA","RECRUITING","2026-05-13",{"date":33,"type":34},"2026-05-15","ACTUAL",{"date":36,"type":34},"2024-09-02",{"date":38,"type":20},"2027-12-09",{"name":40,"class":41},"Jiangsu Nutai Biologics Co., Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100610710","phase-1-a-phase-i-clinical-study-evaluating-the-safety-tolerability-pharmacokinetic-characteristics-and-preliminary-efficacy-of-sxrn-injection-in-patients-with-cancer-cachexia-100610710","NCT07231120","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia","Inclusion Criteria:\n\nParticipants must meet all the following criteria for inclusion:\n\n* 1\\. Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF);\n* 2\\. Patients with histologically or cytologically confirmed advanced solid tumors, with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;\n* 3\\. Diagnosed of cancer anorexia-cachexia based on the 2025 Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome and referring to Chinese population characteristics, i.e., meeting the following criteria (either ① + ② or ① + ③):\n\n  ① \\>5% involuntary weight loss within the past 6 months; or \\>2% weight loss if BMI \\\u003C18.5 kg\u002Fm²; or \\>2% weight loss in the presence of reduced muscle mass;\n\n  ② Anorexia (VAS score ≤70, or FAACT-A\u002FCS score ≤37);\n\n  ③ CRP \\>5 mg\u002FL;\n* 4\\. (Phase Ia only) Cancer patients who have failed or are intolerant (experienced drug-related ≥ Grade 4 hematologic toxicity, or ≥ Grade 3 non-hematologic toxicity) to prior standard therapy, or lack effective conventional treatment options;\n* 5\\. (Phase Ib only) Patients requiring standard anti-tumor drug therapy per CSCO guidelines of advanced pancreatic cancer, non-small cell lung cancer, colorectal cancer, or other eligible solid tumors;\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;\n* 7\\. Life expectancy ≥12 weeks.\n* 8\\. Laboratory test results and organ function assessed within 7 days prior to the first dose must meet the following criteria:\n* Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\\^9\u002FL;2)Platlets (PLT) Count≥75×10\\^9\u002FL; 3)Hemoglobins (Hb) ≥80 g\u002FL.\n\nNote: the criteria above shall still be maintained within 14 days before the initial infusion, either without the need of blood transfusion, or using supportive treatment including granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11 (IL-11), and erythropoietin (EPO), and etc.\n\n* Blood biochemistry: 1)Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); 2)Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft Gault formula ≥30 mL\u002Fmin; 3)Aspartate Amino Transferase (AST), Alanine Aminotransferase (ALT) ≤3×ULN; for participants with liver metastasis, AST, ALT≤5.0×ULN, and ALP≤6.0×ULN; d)Albumin (ALB) ≥30g\u002FL.\n* Urine routines: Urine protein ≤2+ (if \\>2+, 24-hour urine protein quantification must be performed, and total protein ≤1 g is required for eligibility).\n* Blood coagulation: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN.\n\nNote: for subjects receiving precautious anti-coagulation treatment, the investigator shall determine whether INR and APTT remains in a safe and effective range for treatment.\n\n* Ultrasonic cardiogram: Left Ventricular Ejection Fraction (LVEF) ≥50%.\n* 9.The participant must be able to understand and voluntarily sign the written Informed Consent Form (ICF); and must be willing and able to comply with all study procedures and follow-up examinations.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria shall be excluded from the study:\n\n* 1\\. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction preventing adequate oral intake;\n* 2\\. Use of any prescription medication intended to improve appetite or mitigate weight loss within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the investigational product, including but not limited to anamorelin, megestrol acetate, cannabinoids, or medical marijuana;\n* 3\\. Patients currently receiving tube feeding or parenteral nutrition support;\n* 4\\. Treatment with any other investigational drug within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the study drug;\n* 5\\. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;\n* 6\\. Hormonal therapy judged by the investigator as potentially to improve the assessment of cachexia-related outcomes.\n* 7\\. Patients who have undergone major surgery or interventional procedures within 4 weeks prior to the first dose, or who are scheduled to undergo such procedures during the trial (excluding tumor biopsy, puncture, etc.);\n* 8\\. Patients with toxicities from previous antitumor therapies that have not yet recovered to ≤ Grade 1 or baseline levels (except for toxicities judged by the investigator as to pose no safety risk, such as alopecia, or asymptomatic hypothyroidism induced by immune checkpoint inhibitors that is stable and only requires thyroid hormone replacement therapy);\n* 9\\. Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion), meeting any of the following criteria: moderate or larger volume, received local treatment (including drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy, etc.) within 2 weeks before screening or scheduled within the next 2 weeks, significant re-accumulation within 2 weeks after local treatment, or requiring long-term catheterization; or judged by the investigator as unsuitable for enrollment;\n* 10.Patients with central nervous system metastases requiring intervention;\n* 11.History of other malignancies, except for those who have undergone curative treatment with no recurrence within 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, etc.);\n* 12.History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;\n* 13.(Non-infectious) pulmonary inflammation\u002Finterstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;\n* 14.History of severe cardiovascular or cerebrovascular diseases, including but not limited to:\n\n  1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;\n  2. Cardiac dysfunction classified as Class III-IV per the New York Heart Association (NYHA) criteria;\n  3. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular\u002Fcerebrovascular events within 6 months prior to the first dose;\n* 15.Hypertension uncontrolled by a stable regimen of antihypertensive medication (systolic blood pressure ≥160 mmHg, and\u002For diastolic blood pressure ≥100 mmHg);\n* 16.Active chronic hepatitis B (e.g., HBsAg positive or HBcAb positive with HBV DNA above the lower limit of detection), active hepatitis C (e.g., HCV antibody positive with HCV RNA above the lower limit of detection), or human immunodeficiency virus (HIV) infection;\n* 17.Active infection requiring systemic therapy within 2 weeks prior to the first dose;\n* 18.History of active tuberculosis infection within 1 year prior to the first dose;\n* 19.Any other uncontrolled or significant comorbid disease(s), either currently or historically, that by the investigator's judgment may interfere with trial participation or evaluation;\n* 20.Known allergy or contraindication to the investigational product (SXRN injection) or its drug substance process-related impurities (e.g., spectinomycin);\n* 21.For premenopausal female participants (postmenopausal females must be amenorrheic for at least 12 months to be considered of non-childbearing potential): serum pregnancy test as positive, or participants of childbearing potential (including female partners of male participants) who, in the investigator's opinion, are likely to become pregnant, are breastfeeding, or are unwilling to use effective contraception during the study and for at least 6 months after the last dose of the investigational product;\n* 22\\. Any other condition that considered by the investigator as to render the patient unsuitable for participation in the study.",{"count":50,"type":20},54,[52],"PHASE1","This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Phase Ib, an extension of the study, utilizes a design of combination therapy with standard anti-tumor therapy for cancers including but not limited to pancreatic cancer, non-small cell lung cancer (NSCLC), and colon cancer.",[55,56],"Cachexia-Anorexia Syndrome","Solid Tumor Malignancies",[58],"cancer patient with anorexia-cachexia","2025-12-04",{"date":61,"type":34},"2025-12-08",{"date":63,"type":34},"2025-11-17",{"date":65,"type":20},"2026-12-30",{"name":40,"class":41},""]