[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SUNHO（China）BioPharmaceutical CO., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":245},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,73,94,115,137,159,180,205,224],{"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":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100554872","phase-2-to-evaluate-iah0968-in-combination-with-capeox-in-her2-positive-gastric-cancer-100554872",false,"NCT06504732","To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer","A Phase II\u002FIII Clinical Study Evaluating IAH0968 in Combination or Not in Combination With the CAPEOX Regimen in HER2-expressing Advanced\u002FMetastatic Solid Tumors and Gastric Cancer","Inclusion Criteria:\n\n* 1\\) Age 18\\~75 years old (including critical mass), gender is not limited. 2) Phase II cohort 1 only: patients with locally advanced or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction) diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment, and who have not received systemic antitumor therapy (including systemic chemotherapy, molecularly-targeted drug therapy, biologic therapy, and other investigational therapeutic agents) for GC (except for adjuvant chemotherapy for \\>6 months), and who have demonstrated disease progression; and patients who have been diagnosed by immunohistochemistry (IHC) staining and\u002For fluorescence in situ hybridization (FISH). and demonstrated disease progression excepted); HER2 positivity (IHC 3+, or IHC 2+ and FISH +) demonstrated by immunohistochemical (IHC) staining and\u002For fluorescence in situ hybridization (FISH).\n\n  3\\) Phase II Cohort 2 only: Have histologically or cytologically confirmed advanced malignant solid tumors that have failed standard treatment, or for which no standard treatment options are available, or for which standard treatment is not applicable at this stage; and are HER2 underexpressed (IHC 2+ and FISH-, or IHC 1+) as evidenced by immunohistochemistry (IHC) staining and\u002For fluorescence in situ hybridization (FISH).\n\n  4\\) Phase II Cohort 3 only: with locally advanced or metastatic gastric cancer (including gastro-oesophageal junction adenocarcinoma) or colorectal cancer diagnosed by histopathology, unsuitable for radical surgical resection or localized treatment, with no prior systemic (including systemic chemotherapy, molecularly-targeted drug therapy, biologic therapy, and other investigational therapeutic agents) antitumor therapy (having received adjuvant chemotherapy for \\>6 months with evidence of disease progression), patients with wild-type KRAS, NRAS, and BRAF genes (mCRC only); and HER2 low expression (IHC 2+ and FISH-, or IHC 1+) demonstrated by immunohistochemical (IHC) staining and\u002For fluorescence in situ hybridization (FISH).\n\n  5\\) At least 1 measurable lesion according to RECIST 1.1 criteria (tumor lesions located in the area of prior radiotherapy or other localized regional treatment sites are generally not considered measurable lesions unless the lesion shows definite progression or persists after three months of radiotherapy).\n\n  6\\) Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 1. 7) Have an expected survival of ≥ 3 months. 8) Adequate organ function:\n\n  ① 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; Liver function: total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), except Gilbert's syndrome; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 times the ULN, liver metastasis or hepatocellular carcinoma patients need to AST and ALT ≤ 5.0 times the ULN and total bilirubin ≤ 3.0 times the ULN; Renal function: serum creatinine (Cr) ≤1.5 times ULN; if creatinine \\>1.5 times ULN, creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated according to Cockcroft-Gault formula);\n\n  ④ Coagulation function: International Normalized Ratio (INR) ≤ 1.5 times ULN for prothrombinogen, Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times ULN, or INR and APTT ≤ 2.5 times ULN for patients with liver metastasis or hepatocellular carcinoma.\n\n  9\\) Eligible patients (male and female) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for the duration of the trial and for at least 6 months after the last dose; female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.\n\n  10\\) Subjects must give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.\n\n  11)Phase III only: Patients with histologically confirmed locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma), who have received no prior systemic anti-tumor therapy for gastric carcinoma (GC), including systemic chemotherapy, molecular targeted therapy, biotherapy and other investigational medicinal products. One cycle of 5-FU-based chemotherapy is permitted; patients who received neoadjuvant\u002Fadjuvant chemotherapy completed ≥6 months previously with documented disease progression are also eligible. HER2 positivity shall be confirmed via immunohistochemistry (IHC) and\u002For fluorescence in situ hybridization (FISH): defined as IHC 3+, or IHC 2+ with positive FISH result. PD-L1 expression testing on primary or metastatic tumor tissue samples confirms a PD-L1 CPS score \\\u003C1.\n\nExclusion Criteria:\n\n* 1\\) Phase II Cohort 2 only: received antitumor therapy such as chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc. within 4 weeks prior to the first use of study drug, except for the following:\n\n  * Nitrosourea or mitomycin C within 6 weeks prior to first use of study drug;\n\n    * Oral fluorouracil analogs and small molecule targeted drugs for 2 weeks prior to the first use of the study drug or within 5 half-lives of the drug (whichever is longer);\n\n      * Within 2 weeks prior to first use of the study drug for proprietary Chinese medicines with antitumor indications.\n\n        2\\) Received other unlisted clinical investigational drug or therapy within 4 weeks prior to first use of the study drug.\n\n        3\\) Adverse effects of prior antineoplastic therapy have not returned to NCI CTCAE 5.0 grade rating of ≤ grade 1 or relevant provisions of the enrollment criteria (except for toxicities judged by the investigator to pose no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy).\n\n        4\\) Known hypersensitivity to any antibody-based drug (NCI CTCAE 5.0 grade rating ≥ 3) or hypersensitivity to the study drug and the active ingredient or inactive excipients of the CAPEOX regimen.\n\n        5\\) Diagnosed defective mismatch repair (dMMR) or high microsatellite instability (MSI-H) solid tumor (except unknown MSI\u002FMMR status).\n\n        6\\) Major surgical procedure (excluding puncture biopsy), major trauma within 4 weeks prior to first use of study drug, or need for elective surgery during the trial.\n\n        7\\) Received systemic glucocorticosteroids (prednisone \\> 10 mg\u002Fday or equivalent) within 14 days prior to the first dose of study drug, except for the following: treatment with topical, ocular, intra-articular, intranasal, and inhaled glucocorticosteroids; and short-term prophylactic glucocorticosteroids (e.g., for prevention of allergy to contrast media).\n\n        8\\) Other immunosuppressive therapy within 28 days or 5 half-lives (whichever is longer) prior to first use of study drug.\n\n        9\\) Use of immunomodulatory drugs within 14 days prior to first use of study drug.\n\n        10\\) Use of any live vaccine within 4 weeks prior to the first dose of study drug.\n\n        11\\) Previous allogeneic hematopoietic stem cell transplantation or organ transplantation.\n\n        12\\) Parenchymal brain metastases or meningeal metastases with clinical symptoms.\n\n        13\\) Have an active infection that currently requires intravenous anti-infective therapy.\n\n        14\\) Have a history of immunodeficiency, including a positive antibody test for human immunodeficiency virus (HIV).\n\n        15\\) Have active hepatitis B (HBsAg positive and HBV-DNA positive or greater than the upper limit of normal) and active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive or greater than the upper limit of normal).\n\n        16\\) Have severe and uncontrollable lung disease (severe infectious pneumonia, interstitial lung disease, etc.).\n\n        17\\) Have a history of severe cardiovascular disease, including but not limited to:\n  * Having severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block;\n\n    * Mean QT interval (QTcF) corrected by the Fridericia method \\> 470 ms;\n\n      * Acute coronary syndrome, congestive heart failure, aortic coarctation, stroke, or other grade 3 or higher cardiovascular event within 6 months prior to the first dose;\n\n        ④ Presence of New York Heart Association (NYHA) Cardiac Function Class ≥ Grade II heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50%, or other structural heart disease judged by the investigator to be of high risk;\n\n        ⑤ Clinically uncontrolled hypertension. 18) Active, or previous autoimmune disease with potential for relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroid disease, type I diabetes mellitus, vitiligo, cured atopic dermatitis in children, and psoriasis that does not require systemic therapy (within the past 2 years).\n\n        19\\) Presence of other malignancies within 5 years prior to the start of study dosing, except: malignancies for which cure can be expected with treatment (including, but not limited to, adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery).\n\n        20\\) Presence of clinically uncontrollable third interstitial fluid that, in the judgment of the Investigator, makes enrollment inappropriate.\n\n        21\\) Known alcohol or drug dependence. 22) Have a mental disorder or poor compliance. 23) Pregnant or lactating females. 24) In the opinion of the investigator, the subject has a history of other serious systemic disease or is otherwise unsuitable for enrollment in this clinical study.","ALL","18 Years","75 Years",{"count":20,"type":21},574,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects with HER2-expressing advanced\u002Fmetastatic colorectal or gastric cancers (including adenocarcinomas of the gastro-esophageal junction) or HER2-hypo-expressing advanced\u002Fmetastatic solid tumors. The efficacy of IAH0968 in combination with the CAPEOX regimen versus trastuzumab in combination with the CAPEOX regimen in subjects with HER2-positive advanced\u002Fmetastatic gastric cancer, including gastro-esophageal junction adenocarcinoma, was then assessed by progression-free survival (PFS) and OS according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.",[28,29],"Stomach Neoplasms","Solid Tumor",[31,32],"gastric cancer","HER2-positive","RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-05","ACTUAL",{"date":39,"type":37},"2024-08-15",{"date":41,"type":21},"2029-07",{"name":43,"class":44},"SUNHO（China）BioPharmaceutical CO., Ltd.","INDUSTRY",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100632665","phase-1-first-in-human-study-of-ish0613-safety-tolerability-pharmacokinetics-and-pharmacodynamics-100632665","NCT07516639","First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics","A Randomized, Double-Blind, Placebo-Controlled Phase Ia First-in-Human Study to Evaluate the Single Intravenous Administration of ISH0613 in Healthy Subjects","Inclusion Criteria:\n\n1. Healthy Chinese adult subjects, male or female, aged 18 to 45 years (inclusive);\n2. Body mass index (BMI) between 19.0 and 28.0 kg\u002Fm² (inclusive); body weight generally ≥50 kg for males and ≥45 kg for females;\n3. Male subjects and their partners, or female subjects, must agree to use at least one effective non-pharmacological contraceptive method (e.g., complete abstinence, intrauterine device, partner sterilization) during the study period, and must have no plan for sperm or egg donation;\n4. Subjects are able to fully understand the purpose, nature, and procedures of the study, including potential adverse reactions, and voluntarily sign the informed consent form (ICF);\n5. Subjects are able to communicate well with the investigator and are willing and able to comply with all study procedures and requirements.\n\nExclusion Criteria:\n\n1. Known allergy to the investigational product or any of its excipients, or a history of hypersensitivity to monoclonal antibodies;\n2. History or presence of clinically significant diseases of the cardiovascular, endocrine, nervous, gastrointestinal, respiratory, genitourinary, hematological, immunological, psychiatric, or metabolic systems, or any other condition that may interfere with study results, as judged by the investigator;\n3. Clinically significant abnormalities in laboratory tests (hematology, urinalysis, biochemistry, coagulation) or auxiliary examinations (chest X-ray, abdominal ultrasound);\n4. Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody, or syphilis antibody;\n5. Receipt of any surgical procedure within 6 months prior to signing the informed consent form, or planned surgery (including cosmetic, dental, or oral surgery) within 2 weeks after the end of the study;\n6. Alcohol consumption exceeding 14 units per week within 3 months prior to screening (1 unit = 360 mL beer, 150 mL wine, or 45 mL liquor), or positive alcohol breath test at screening or baseline, or inability to abstain from alcohol during the study;\n7. Average smoking of more than 5 cigarettes per day within 3 months prior to screening;\n8. History of drug abuse, use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., cocaine, phencyclidine) within 1 year prior to screening, or positive drug abuse screening test (including morphine, ketamine, THC-COOH, methamphetamine, MDMA, cocaine);\n9. Habitual excessive intake within 4 weeks prior to screening of caffeine-containing beverages or foods or substances that may affect drug metabolism, such as coffee (\\>1100 mL\u002Fday), tea (\\>2200 mL\u002Fday), cola (\\>2200 mL\u002Fday), energy drinks (\\>1100 mL\u002Fday), or chocolate (\\>510 g\u002Fday);\n10. Use of any prescription drugs, over-the-counter medications, or traditional Chinese medicines within 14 days prior to dosing;\n11. Receipt of any monoclonal antibody therapy within 6 months prior to dosing;\n12. Vaccination within 3 months prior to dosing, or planned vaccination during the study period;\n13. Participation in another clinical trial and receipt of investigational drug treatment within 3 months prior to dosing;\n14. Blood donation or significant blood loss (\\>400 mL, excluding menstrual loss) within 3 months prior to screening, or receipt of blood transfusion or blood products, or planned blood donation during the study period or within 1 month after study completion;\n15. Pregnant or lactating women;\n16. Clinically significant abnormal vital signs (systolic blood pressure \\\u003C90 mmHg or ≥140 mmHg; diastolic blood pressure \\\u003C55 mmHg or ≥90 mmHg; heart rate \\\u003C50 bpm or \\>100 bpm; body temperature \\\u003C35.4°C or \\>37.3°C), or clinically significant ECG abnormalities (QTcF \\>450 ms for males, \\>470 ms for females), or clinically significant findings on physical examination, as judged by the investigator;\n17. Presence of infection requiring treatment for acute or chronic infection, including but not limited to:\n\n    1. Herpes zoster within 12 months prior to screening;\n    2. Current suppressive therapy for chronic infections (e.g., tuberculosis, Pneumocystis, cytomegalovirus, herpes simplex virus, varicella-zoster virus, or atypical mycobacteria);\n    3. History of tuberculosis or contact with active tuberculosis within 6 months prior to screening, or positive T-SPOT test;\n    4. Parasitic infection within 3 months prior to dosing;\n    5. Hospitalization due to infectious disease within 30 days prior to dosing;\n    6. Parenteral anti-infective treatment (including antibacterial, antiviral, antifungal, or antiparasitic agents) within 30 days prior to dosing;\n18. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.",true,"45 Years",{"count":56,"type":21},26,[58],"PHASE1","The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults.\n\nThis study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose.\n\nThe main questions this study aims to answer are:\n\nI. What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects.\n\nParticipants will:\n\nI. Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study",[61,62],"Healthy Subjects (HS)","SLE (Systemic Lupus)","NOT_YET_RECRUITING","2026-04-07",{"date":66,"type":37},"2026-04-13",{"date":68,"type":21},"2026-04-01",{"date":70,"type":21},"2026-12-31",{"name":43,"class":44},1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":72},"100631773","phase-1-first-in-human-study-of-ish0688-safety-tolerability-pharmacokinetics-and-pharmacodynamics-100631773","NCT07505043","First-in-Human Study of ISH0688: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate ISH0688 Subcutaneous Injection","Inclusion Criteria:\n\n1. Female subjects:\n\n   * Not of childbearing potential: Including surgical sterilization performed at least 6 weeks prior to screening (with documented records of bilateral tubal ligation, bilateral salpingectomy, hysterectomy, or bilateral oophorectomy), or postmenopausal with continuous amenorrhea for ≥12 months; or\n   * Of childbearing potential: Must not be pregnant or breastfeeding, and must agree to use adequate contraception from 30 days prior to first dosing throughout the study period and for 6 months after the last dose;\n   * Serum β-human chorionic gonadotropin (β-hCG) pregnancy test results must be negative at both screening and baseline visits;\n2. Male subjects with female partners of childbearing potential must agree to use adequate contraception from 30 days prior to first dosing throughout the study period and for 6 months after the last dose;\n3. Male subjects must have no plan to donate sperm from the time of informed consent signing until 6 months after study completion; female subjects must have no plan to donate eggs from the time of informed consent signing until 6 months after study completion;\n4. All subjects must be able to understand the procedures and methods of this study, be willing to strictly comply with the clinical study protocol to complete this study, and voluntarily sign the informed consent form.\n\nAdditional inclusion criteria for Part 1:\n\n1. Male or female subjects aged 18 to 65 years (inclusive);\n2. Male body weight ≥50.0 kg, female body weight ≥45.0 kg, with body mass index (BMI) ≥19.0 and \\\u003C28.0 kg\u002Fm²;\n3. Fasting triglycerides (TG) \\\u003C2.3 mmol\u002FL (200 mg\u002FdL);\n4. Comprehensive vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and laboratory tests (complete blood count, blood biochemistry, urinalysis, stool routine, coagulation function, thyroid function) showing no abnormalities or only minor abnormalities that are judged by the investigator to be of no clinical significance. For clinically significant abnormal laboratory findings, retesting may be performed within one week if there is a clear and reasonable justification, and the retest results will be used to determine subject eligibility.\n\nAdditional screening period inclusion criteria for Part 2:\n\n1. Male or female subjects aged 18 to 75 years (inclusive);\n2. Male body weight ≥50.0 kg, female body weight ≥45.0 kg, with body mass index (BMI) in the range of 19.0 to 45.0 kg\u002Fm² (inclusive);\n3. Lipid levels at screening or within 1 week prior to screening (at this site) meeting: fasting TG ≥2.3 mmol\u002FL (200 mg\u002FdL);\n4. Lipid-lowering medication use within 28 days prior to screening must meet the following criteria: For TG \\\u003C5.7 mmol\u002FL (500 mg\u002FdL): no lipid-lowering medication use or receiving stable-dose lipid-lowering therapy for ≥28 days; For TG ≥5.7 mmol\u002FL (500 mg\u002FdL): must first receive stable-dose lipid-lowering therapy for ≥28 days; (Lipid-lowering therapy: niacin, prescription-grade fish oil, fibrates, statins, cholesterol absorption inhibitors, etc.; PCSK9 inhibitors require 6 months of stability prior to screening);\n5. At screening, liver fat content (LFC) assessed by MRI-PDFF ≥8% in some participants;\n6. Able to accept therapeutic lifestyle interventions consistent with local standards and maintain stable lifestyle throughout the study period, avoiding alcohol consumption and strenuous exercise within 48 hours prior to each visit.\n\nAdditional double-blind treatment period inclusion criteria for Part 2:\n\n1. Meet all inclusion criteria and do not meet any exclusion criteria during the screening period;\n2. Undergo therapeutic lifestyle intervention during the lead-in period, maintain a stable lifestyle, and be judged by the investigator as capable of complying with the protocol to receive study treatment and complete other clinical trial procedures;\n3. Two TG tests during the lead-in period with an interval of ≥7 days, with the mean of the 2 TG values meeting 2.3 mmol\u002FL (200 mg\u002FdL) ≤ fasting TG \\\u003C 11.3 mmol\u002FL (1000 mg\u002FdL);\n4. The last TG test is within 7 days prior to the first dosing (D1).\n\nExclusion Criteria:\n\n1. Subjects with current allergic diseases, history of allergy to therapeutic or diagnostic protein products, or allergy to two or more drugs and\u002For non-drug factors;\n2. Subjects with history of malignant tumors (regardless of cure status, except for basal cell carcinoma, squamous cell skin cancer, and cervical carcinoma in situ);\n3. Subjects with positive results for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or serum treponema pallidum antibody (TP-Ab) (if HBsAg positive, must also have positive HBV-DNA; if HCV-Ab positive, must also have positive HCV-RNA);\n4. Subjects with severe trauma or surgical history within 6 months prior to screening; or subjects planning to undergo surgery (including cosmetic surgery, dental surgery, and oral surgery, etc.) during the trial period;\n5. Subjects with body weight change ≥5% within 3 months prior to screening (self-reported), or use of other medications\u002Ftreatments for weight reduction within 1 month prior to screening or planned during the study period;\n6. Subjects with history of frequent orthostatic hypotension episodes within 6 months prior to screening;\n7. Subjects with history of chronic pancreatitis or acute pancreatitis attack within 1 year prior to screening;\n8. Subjects with gallbladder history and symptoms (such as: common bile duct stones, multiple gallbladder stones, etc., unless cholecystectomy performed and ≥6 months since surgery);\n9. Subjects with alcohol consumption \\>14 units per week within 3 months prior to screening (1 unit of alcohol = 360 mL beer, 150 mL wine, or 45 mL spirits with 40% alcohol content), or positive alcohol breath test (at baseline);\n10. Drug abusers or subjects using soft drugs (e.g., marijuana) within 3 months prior to screening or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to screening, or positive drug abuse screening (morphine, ketamine, tetrahydrocannabinol acid, methamphetamine, methylenedioxymethamphetamine, cocaine);\n11. Subjects who have used products targeting FGF21 within 1 year prior to screening, such as BIO89-100, DR10624, etc.;\n12. Subjects with history of vaccination within 3 months prior to screening, or planning to receive vaccination during the trial period;\n13. Subjects who participated in any other clinical trial of drugs or medical devices within 3 months prior to screening (except those who did not use investigational drugs\u002Fmedical devices); or subjects within 5 half-lives of a drug (if 5 half-lives of the investigational drug exceed 3 months);\n14. Subjects who donated blood or experienced massive blood loss (\\>400 mL, excluding female menstrual period) or received blood transfusion or blood products within 3 months prior to screening, or subjects planning to donate blood during the trial period;\n15. Subjects with severe infection within 3 months prior to screening, including but not limited to: severe pneumonia, lung abscess, meningitis, cellulitis, etc., judged by the investigator as unsuitable for participation in this trial;\n16. Subjects with strenuous exercise during the trial period, or significant changes in exercise or dietary habits;\n17. History of needle phobia or blood phobia, or inability to tolerate venipuncture;\n18. Subjects with dermatitis or abnormal skin conditions at or around the administration site;\n19. Subjects whom the investigator considers unsuitable for participation in this study for any other reason.\n\nAdditional exclusion criteria in Part 1:\n\n1. Abnormal vital signs at screening in one or more parameters, or abnormal 12-lead electrocardiogram, or clinically significant abnormal physical examination findings;\n2. Clinically significant abnormal laboratory findings meeting the following criteria: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) \\>1.5×ULN; estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin\u002F1.73m²;\n3. Presence of severe, progressive, or uncontrolled diseases, including but not limited to immune system, endocrine system, hematological system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, or digestive system disorders, which in the judgment of the investigator would increase the risk to the subject by participating in this study;\n4. Use of any prescription drugs, over-the-counter drugs, proprietary Chinese medicines, or herbal medicines within 14 days or 5 half-lives prior to screening (whichever is longer) (excluding oral contraceptives, acetaminophen, and ibuprofen);\n5. Smoking more than 5 cigarettes per day on average within 3 months prior to screening;\n6. Excessive consumption of tea, coffee, or caffeine-containing beverages within 3 months prior to screening (more than 8 cups per day of corresponding beverages, 1 cup = 250 mL), or consumption of any caffeine-containing food or beverages (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours prior to first dosing.\n\nAdditional exclusion criteria in Part 2:\n\n1. Known diagnosis of familial chylomicronemia syndrome (FCS) (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III); or strong suspicion of any of the above 3 conditions;\n2. Body weight decrease ≥5% from screening period to prior to receiving double-blind treatment;\n3. Clinically significant 12-lead electrocardiogram (ECG) abnormalities at screening;\n4. Clinically significant abnormal laboratory findings meeting the following criteria: alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>3.0×ULN, total bilirubin (TBIL) \\>2.0×ULN, creatine kinase (CK) \\>1.5×ULN; creatinine (Cr) \\>176 μmol\u002FL and\u002For estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²; hemoglobin \\\u003C110 g\u002FL (males) or \\\u003C100 g\u002FL (females); platelet count (PLT) \\\u003C60×10⁹\u002FL; thyroid stimulating hormone (TSH) \\\u003Clower limit of normal (LLN) or \\>1.5×ULN; serum amylase or lipase \\>2.0×ULN;\n5. Type 1 diabetes mellitus; or newly diagnosed Type 2 diabetes mellitus within 3 months; or poorly controlled Type 2 diabetes mellitus (HbA1c ≥9.5%); or Type 2 diabetes mellitus with severe complications; or failure to maintain stable dose of hypoglycemic agents for ≥3 months prior to screening;\n6. Uncontrolled or poorly controlled hypertension at screening: resting seated systolic blood pressure (SBP) ≥160 mmHg and\u002For diastolic blood pressure (DBP) ≥100 mmHg; or failure to maintain stable dose of antihypertensive agents for ≥3 months prior to screening;\n7. Use (≥3 days) of other drugs significantly affecting blood lipids from 28 days prior to screening through the entire trial period (excluding lipid-lowering drugs specified in Inclusion Criterion 4), including proprietary Chinese medicines containing statin components, and other drugs and health supplements with lipid-lowering effects;\n8. Presence of other severe, progressive, or uncontrolled diseases in addition to T2DM, hypertension, and dyslipidemia, including but not limited to immune system, endocrine system, hematological system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, or digestive system disorders, which in the judgment of the investigator would increase the risk to the subject by participating in this study;\n9. Subjects who, in the investigator's assessment, require systemic corticosteroid therapy during the study period due to comorbidities, or who have received continuous or cumulative systemic corticosteroid therapy for more than 14 days within 6 months prior to screening (stable-dose inhaled or topical corticosteroids are permitted);\n10. Presence of contraindications to MRI examination or inability to cooperate with MRI examination;\n11. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n12. Atherosclerotic cardiovascular disease within 6 months prior to screening;\n13. Major cardiovascular or cerebrovascular events within 6 months prior to screening;\n14. Severe arrhythmia within 3 months prior to screening;\n15. History of or current nephrotic syndrome, severe liver disease, Cushing's syndrome, or other diseases significantly affecting blood lipid levels;\n16. History of or current hyperthyroidism or hypothyroidism.",{"count":81,"type":21},104,[58],"ISH0688 is a human IgG1 Fc-FGF21 fusion protein. The objectives of the planned clinical investigation will be to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-ascending doses of ISH0688 via subcutaneous injection.",[85,86],"Healthy Subjects","Hyperlipidemia, Hypertriglyceridemia","2026-03-26",{"date":68,"type":37},{"date":90,"type":21},"2026-03-01",{"date":92,"type":21},"2027-02-28",{"name":43,"class":44},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100598792","phase-2-a-phase-iiiii-study-of-ibb0979-in-combination-with-topotecan-versus-topotecan-in-relapsed-small-cell-lung-cancer-100598792","NCT07076095","A Phase II\u002FIII Study of IBB0979 in Combination With Topotecan Versus Topotecan in Relapsed Small Cell Lung Cancer","A Phase II\u002FIII Study to Compare IBB0979 in Combination With Topotecan Versus Topotecan in Subjects With Relapsed Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Aged ≥18 and ≤75 years, male or female.\n2. Histologically confirmed SCLC.\n3. Relapsed small cell lung cancer (limited-stage, extensive-stage) that has failed or progressed after first-line or second-line systemic therapy.\n4. At least one measurable lesion according to RECIST version 1.1.\n5. ECOG PS 0 or 1.\n6. Life expectancy ≥ 3 months.\n7. Adequate organ function.\n8. Men or women should be using adequate contraceptive measures throughout the study. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.\n9. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.\n2. Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.\n3. History of anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration.\n4. History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.\n5. 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.\n6. History of systemic corticosteroid therapy with exceptions defined in the protocol.\n7. 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.\n8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of investigational product administration.\n9. History of prior allogeneic stem-cell or solid organ transplantation.\n10. Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.\n11. Untreated brain metastases with exceptions defined in the protocol.\n12. Evidence of active infection requiring intravenous anti-infective therapy.\n13. Have a history of immune deficiency, including a positive test for human immunodeficiency virus (HIV) antibodies.\n14. Active hepatitis B, active hepatitis C.\n15. Currently has interstitial lung disease (with exception of radiation pulmonary fibrosis that requires no hormone therapy).\n16. History of severe cardiovascular and cerebrovascular diseases.\n17. Active or suspected autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with exceptions defined in the protocol.\n18. History of ≥ grade 3 immune-related adverse events (irAE) or Grade 2 immune-associated myocarditis accompanied with immunotherapy with exceptions defined in the protocol.\n19. History of other malignancy with exceptions defined in the protocol.\n20. Pleural effusion\u002Fperitoneal effusion\u002FPericardial effusion requiring clinical intervention.\n21. Known alcohol or drug dependence.\n22. History of mental disorder or poor adherence.\n23. The female patient who is pregnant or breastfeeding.\n24. 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.",{"count":102,"type":21},200,[24],"This study was designed to compare the efficacy and safety of IBB0979 in combination with topotecan versus topotecan in subjects with relapsed small cell lung cancer (SCLC).",[106],"Small Cell Lung Cancer","2025-07-17",{"date":109,"type":37},"2025-07-21",{"date":111,"type":21},"2025-08-01",{"date":113,"type":21},"2031-08-01",{"name":43,"class":44},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":72},"100538543","phase-1-a-clinical-trial-to-evaluate-effect-of-ibd0333-in-patients-with-advanced-malignant-tumors-100538543","NCT06292208","A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors","Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) and Preliminary Efficacy of IBD0333 in Patients With Locally Advanced\u002FMetastatic Solid Tumor or Non-Hodgkin Lymphoma","Inclusion Criteria\n\nIn order to be eligible for participation in this trial, the patient must:\n\n1. Male or female, 18 to 80 years old.\n2. Patients with histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumor or non-Hodgkin lymphoma who have failed or have no standard therapy, or for whom the standard therapy is intolerant.\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 (solid tumors) or Lugano 2014 (lymphomas) (tumor lesions located in areas of prior radiotherapy or other localized regional treatment areas are generally not considered as measurable lesions unless the lesion shows definite progression or persists after 3 months of radiotherapy).\n4. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n5. Have a life expectancy of at least 3 months.\n6. Have adequate organ function as indicated by the following laboratory values.\n\n   1. Hematological (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   2. Hepatic: total bilirubin (TBIL)≤1.5×upper limit of normal (ULN), except for Gilbert syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3.0×ULN, or ALT and AST ≤ 5.0×ULN in patients with liver metastases or liver cancer;\n   3. Renal: creatinine clearance (Ccr)≥50mL\u002Fmin (calculated according to the Cockcroft-Gault Method:);\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.\n7. Eligible patients (male and female) of childbearing potential must agree to use a reliable contraception measure (hormonal or barrier contraception or abstinence) with their partner for the duration of the trial and for at least 120 days after the discontinuation of investigational product. Female patients of childbearing potential must have a negative serum pregnancy test at within 7 days of first dose of investigational product.\n8. According to the investigator's assessment, the patient could benefit from IBD0333.\n9. Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.\n\nExclusion Criteria\n\n1. Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or any excipient contained in the drug or vehicle formulation for IBD0333.\n2. History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune costimulatory molecule agonist.\n3. History of anti-cancer therapies prior to the initiation of investigational product (chemotherapy within 3 weeks; radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks) and the following are except:\n\n   1. Nitrosourea or mitomycin C within 6 weeks prior to the initiation of investigational product;\n   2. Oral fluorouracil and small molecule-targeted drugs within 2 weeks prior to the initiation of investigational product;\n   3. Chinese patent drugs within 2 weeks prior to the initiation of investigational product.\n4. History of investigational anti-cancer drug within 4 weeks prior to the initiation of investigational product.\n5. History of major surgery (except for puncture biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product, or require the selective surgery during the trial.\n6. History of systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or immunosuppressive medication \\\u003C14 days prior to the initiation of investigational product. Steroids for topical, ocular, intra-articular, intranasal and inhaled and short-term prophylactic treatment (e.g., to prevent contrast allergy) were allowed.\n7. Treatment with immunomodulatory agents within 14 days prior to the initiation of investigational product, including but not limited to thymidine, interleukin-2, interferon, etc.\n8. Vaccination with live attenuated vaccine within 4 weeks prior to the initiation of investigational product.\n9. History of allogeneic hematopoietic stem cell or organ transplantation.\n10. The adverse effects related to prior anticancer treatment (except alopecia, peripheral neurotoxicity with grade 2, and stable hypothyroidism after hormone replacement therapy or the other toxicities judged by the investigator without safety risk) that have not resolved to ≤ Grade 1 according to common terminology criteria for adverse events (NCI-CTCAE 5.0) or relevant provisions of the inclusion criteria prior to initiation of investigational product.\n11. Parenchymal brain metastases or meningeal metastases unless previously received therapies and have no evidence of progression on magnetic resonance imaging (MRI) or computed tomography (CT) for at least 8 weeks after the treatment and for 4 weeks prior to the initiation of investigational product.\n12. Evidence of active infection requiring intravenous systemic therapy.\n13. History of immunodeficiency, including the positive for human immunodeficiency virus (HIV) antibodies.\n14. Active hepatitis B infection (HBsAg positive and HBV-DNA \\> 500 IU\u002FmL or lower limit of detection \\[only if lower limit is above 500 IU\u002FmL\\]). Active hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.\n15. Has interstitial lung disease (except for the radiographic pulmonary fibrosis without hormone therapy).\n16. History of serious cardiovascular disease, including but not limited to:\n\n    1. Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc.;\n    2. The mean QT interval corrected for heart rate by Fridericia's formula (QTcF) \\>470msec.\n    3. History of acute coronary syndromes, congestive heart failure, aortic dissection, stroke or other cardiovascular or cerebrovascular ≥ grade 3 within the 6 months prior to initiation of investigational product.\n    4. Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system or left ventricular ejection fraction (LVEF) \\\u003C 50%, or structural heart disease with high risk judged by investigators;\n    5. Uncontrollable hypertension.\n17. Previous or current autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for the stable autoimmune thyroid disease, type I diabetes, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years and without systemic therapy).\n18. History of ≥Grade 3 Immune-Related Adverse Events (irAE) or ≥Grade 2 immune-associated myocarditis (experienced immune-associated thyroid toxicity ≥grade 3 could be enrolled).\n19. History of malignancy or current other malignant tumors (other than in non-melanoma skin cancer, localized prostate cancer, carcinoma in situ \\[situ cervical cancer\\] treated with curative intent and without evidence of disease for 2 years or longer).\n20. Has uncontrollable third interstitial fluid that are unsuitable for enrollment (judged by the investigator).\n21. Has alcohol or drug dependence.\n22. Has a psychiatric disorder or poor compliance.\n23. Pregnant or breastfeeding. Have serious systemic disease or are unsuitable for participation in the study.","80 Years",{"count":124,"type":21},48,[58,24],"Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced\u002Fmetastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and\u002For dose limiting toxicity (DLT).\n\nDose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced\u002Fmetastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D).\n\nClinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor.\n\nSecondary objectives Dose escalation phase \\& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced\u002Fmetastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced\u002Fmetastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced\u002Fmetastatic solid tumor or non-Hodgkin lymphoma.\n\nClinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.",[128],"MTD","2025-01-15",{"date":131,"type":37},"2025-01-17",{"date":133,"type":37},"2024-03-09",{"date":135,"type":21},"2030-12-31",{"name":43,"class":44},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":122,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":72},"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.",{"count":145,"type":21},25,[58,24],"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.",[149],"Advanced Malignant Tumors",[149,151,152],"B7-H3","IL-10",{"date":131,"type":37},{"date":155,"type":37},"2023-07-03",{"date":157,"type":21},"2025-12-30",{"name":43,"class":44},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":72},"100560766","phase-1-a-clinical-trial-to-evaluate-effect-of-iap0971-in-patients-with-advanced-malignant-tumors-100560766","NCT06581419","A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","A Phase I\u002FII Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors","Inclusion Criteria:\n\n1. Age of 18-75 years old (including cut-off value), regardless of gender.\n2. Phase I only: patients with histologically confirmed advanced or metastatic malignant solid tumors who have failed to respond to standard treatment, who have no standard treatment options, who are not currently applicable to standard treatment, or who have been assessed by the investigator to benefit from this treatment.\n3. Phase II only: patients with histologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and definitive concurrent chemoradiotherapy. Note: For patients with locally advanced stage (stage IIIB\u002FIIIC) who cannot accept radical concurrent\u002Fsequential chemoradiotherapy, they need to be evaluated by relevant professional physicians and confirmed by written records.\n4. Phase II only: no prior systemic antitumor therapy for locally advanced or metastatic NSCLC (except for patients who received adjuvant\u002Fneoadjuvant chemotherapy or definitive concurrent or sequential chemoradiotherapy for locally advanced disease and disease progression ≥6 months after the last treatment).\n5. Phase II only: PD-L1 positive (TPS≥50%) as determined by IHC, and patients were negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) by immunohistochemistry.\n6. have at least one measurable lesion according to RECIST 1.1 criteria (tumor lesion located in the previous radiotherapy area or other locoregional treatment site, generally not considered a measurable lesion unless the lesion has clearly progressed or persists beyond three months of radiotherapy).\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n8. predicted survival time ≥3 months.\n9. with adequate organ function:\n\n   ① Blood system (no blood transfusion or hematopoietic stimulation therapy within 14 days) : absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (HGB) ≥90 g\u002FL; ② Liver function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), except Gilbert's syndrome Out of; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, and patients with liver metastasis or liver cancer need AST and ALT≤5.0 times ULN and total bilirubin ≤3.0 times ULN;\n\n   ② Renal function: serum creatinine (Cr) ≤1.5 times ULN; If creatinine \\> 1.5 times ULN, creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula) was required.\n\n   ③ Coagulation function: prothrombin international normalized ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN, patients with liver metastasis or liver cancer need INR and APTT≤2.5 times ULN.\n10. Eligible patients (men and women) of childbearing potential must consent to use a reliable method of contraception (hormonal or barrier methods or abstinence) with their partner during the trial and for at least 6 months after the last dose; Female patients of reproductive age had to have a negative blood pregnancy test within 7 days before the first use of the study drug.\n11. Subjects must give informed consent for this study and voluntarily provide written informed consent before the trial.\n\nExclusion Criteria:\n\n1. Phase II only: small cell lung cancer or sarcomatoid lesion confirmed by histopathology.\n2. Phase II only: previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 \u002FPD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action.\n3. Phase I only: patients received anti-tumor therapy such as systemic chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of study drug; The following drugs were excluded according to the following criteria:\n\n   ① Treatment with a small-molecule tyrosine kinase inhibitor within 2 weeks before the first dose;\n\n   ② Palliative local treatment for non-target lesions within 2 weeks before the first dose; Patients received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, not including IL-11) within 2 weeks before the first dose;\n\n   ③ received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose.\n4. received other investigational drugs or treatments within 4 weeks before the study drug.\n5. received systemic glucocorticoids (prednisone \\> 10 mg\u002F day or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug; The use of topical, ocular, intra-articular, nasal, and inhaled glucocorticoids was excluded. Short-term prophylaxis with glucocorticoids (e.g., to prevent contrast allergy).\n6. the adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 or the relevant requirements of the inclusion criteria (except for toxicities without safety risks judged by the investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy).\n7. major surgical procedures (excluding needle biopsies) within 4 weeks before the first dose of study drug, major trauma, or the need for elective surgery during the trial.\n8. prior allogeneic hematopoietic stem-cell transplantation or organ transplantation.\n9. clinically symptomatic parenchymal or meningeal metastases.\n10. have active infection and currently require intravenous anti-infective therapy.\n11. have a history of immunodeficiency, including testing positive for human immunodeficiency virus (HIV) antibodies.\n12. active hepatitis B (HBsAg positive and HBV-DNA positive or greater than the upper limit of normal), active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive or greater than the upper limit of normal).\n13. received any live vaccine within 4 weeks before the first dose of study drug.\n14. known hypersensitivity to any antibody-based drug (NCI CTCAE grade 5.0 ≥3) or to the study drug, active ingredient, or inactive excipients of a PD-1\u002FPD-L1 inhibitor.\n15. with severe and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.); Or other moderate-to-severe lung diseases that severely affect respiratory function that may interfere with the detection or management of drug-related pulmonary toxicity.\n16. have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n    ① Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.\n\n    ② Mean QT interval corrected with Fridericia's method (QTcF) \\> 470 ms;\n\n    ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first dose; ④ patients with New York Heart Association (NYHA) functional class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or structural heart disease with high risk as judged by other investigators; And 5) clinically uncontrolled hypertension.\n17. have an active or previous autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with the possibility of recurrence, except clinically stable autoimmune thyroid disease, type I diabetes mellitus, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years) that does not require systemic treatment.\"\n18. had other malignancies within 5 years before study administration, except for malignancies that could be expected to be cured with treatment (including, but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).\n19. have clinically uncontrollable effusion in the third space, which was judged by the investigator to be not suitable for enrollment.\n20. known alcohol or drug dependence.\n21. with mental disorders or poor adherence.\n22. pregnant or lactating women.\n23. The participant was deemed by the investigator to have a history of other serious systemic diseases or to be ineligible for the study for other reasons.",{"count":167,"type":21},78,[58,24],"Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors.\n\nPhase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.",[171,172],"Advanced Malignant Neoplasm","Advanced or Metastatic Non-small Cell Lung Cancer","2025-01-13",{"date":129,"type":37},{"date":176,"type":37},"2024-12-31",{"date":178,"type":21},"2029-08-01",{"name":43,"class":44},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":196,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":4},"100571378","phase-2-a-clinical-trial-to-evaluate-effect-of-iae0972-combined-with-chemotherapy-for-rm-hnscc-or-npcnote-it-is-currently-phase-ii-100571378","NCT06719479","A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R\u002FM HNSCC or NPC(Note: It is Currently Phase II.).","A Phase II\u002FIII Clinical Trial to Evaluate the Effect of IAE0972 Combined with Chemotherapy Selected by Doctors for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma\u002FNasopharyngeal Carcinoma.","Inclusion Criteria:\n\n1. The age is 18\\~75 years old (including the critical value), regardless of gender.\n2. Phase II cohort 1, cohort 2: locally advanced squamous cell carcinoma of the head and neck which only occurred in the oral cavity, oropharynx, hypopharynx and larynx after histological diagnosis or had no indication of radical local treatment; In the past, I only received ≤2 line therapy for recurrent and metastatic head and neck squamous cell carcinoma.\n3. Phase II cohort 3, cohort 4, cohort 5: Histologically confirmed nasopharyngeal carcinoma, stage IVb or recurrent nasopharyngeal carcinoma that is not suitable for local treatment according to the TNM of AJCC nasopharyngeal carcinoma in the 8th edition of 2017; In the past, they only received ≤2 line therapy for recurrent and metastatic nasopharyngeal carcinoma.\n4. According to the researcher's judgment, the chemotherapy in this experiment is applicable.\n5. According to the RECIST 1.1 standard, there is at least one measurable lesion (tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not regarded as measurable lesions, unless the lesions make clear progress or persist after radiotherapy for three months).\n6. The score of physical condition of the ECOG is 0\\~1.\n7. The estimated survival time is ≥3 months.\n8. Have sufficient organ functions:\n\n   * Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): ANC≥1.5×109\u002FL, PLT≥90×109\u002FL, HGB≥ 90 g\u002FL; ② Liver function: TBIL≤1.5 times the ULN, except Gilbert syndrome; AST and ALT are ≤3.0 times ULN, while subjects with liver metastasis or liver cancer need AST and ALT≤3.0 times ULN and total bilirubin ≤ 3.0 times ULN;\n\n     * Renal function: Cr≤1.5 times ULN; If the creatinine is more than 1.5 times ULN, the CCR should be ≥ 50 ml\u002Fmin (calculated according to Cockcroft-Gault formula);\n\n       * Coagulation function: INR≤1.5 times ULN, APTT≤1.5 times ULN, and INR and APTT≤2.5 times ULN for patients with liver metastasis or liver cancer.\n9. Qualified fertile subjects (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the trial and at least 6 months after the last medication; The blood pregnancy test of female subjects of childbearing age must be negative within 7 days before the first use of the study drug.\n10. Subjects must give informed consent to this study before the experiment, and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Having received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the investigating drug, the following drugs should be excluded according to the following criteria:\n\n   ① Nitrosourea or mitomycin C was used within 6 weeks before the first use of the study drug;\n\n   ② Oral administration of fluorouracil and small molecule targeted drugs 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer);\n\n   ③ Chinese patent drugs with anti-tumor indications were used within 2 weeks before the first use of the study drugs.\n2. Received other unlisted clinical research drugs or treatments within 4 weeks before using the research drugs.\n3. The adverse reactions of previous anti-tumor treatments have not recovered to NCI CTCAE 5.0 grade evaluation ≤1 grade or the relevant provisions of the selection criteria (except for the toxicity that the researchers judged to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).\n4. It is known that it has hypersensitivity to any antibody drugs (NCI CTCAE 5.0 rating is ≥3), or it has hypersensitivity to research drugs, active ingredients or inactive excipients of chemotherapy schemes.\n5. Have received major surgery (excluding puncture biopsy), major trauma or need to undergo elective surgery during the trial within 4 weeks before the first use of the study drug.\n6. Having received systemic corticosteroids (prednisone \\> 10 mg\u002Fday or similar drugs with the same dose) within 14 days before the first use of the study drug, except for the following cases: using topical, ophthalmic, intra-articular and intranasal corticosteroids; Short-term use of glucocorticoids for preventive treatment (for example, prevention of contrast agent allergy).\n7. Treatment with other immunosuppressants within 28 days or 5 half-lives (whichever is longer) before the first use of the study drug.\n8. Have used immunomodulatory drugs within 14 days before the first use of the study drug (Appendix 5).\n9. Have been vaccinated with any live vaccine within 4 weeks before the first use of the study drug.\n10. Received allogeneic hematopoietic stem cell transplantation or organ transplantation in the past.\n11. Brain parenchymal metastasis or meningeal metastasis with clinical symptoms.\n12. It has active infection and needs intravenous anti-infection treatment at present.\n13. Have a history of immunodeficiency disease, including positive detection of HIV antibody.\n14. Active hepatitis B (HBsAg positive and HBV-DNA positive or above the upper limit of normal value) and active hepatitis C (HCV antibody positive and HCV RNA positive or above the upper limit of normal value).\n15. Having serious and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.).\n16. Have a serious history of cardiovascular and cerebrovascular diseases, including but not limited to:\n\n    ① Severe cardiac rhythm or conduction abnormality, such as ventricular arrhythmia requiring clinical intervention and II-III degree atrioventricular block;\n\n    ② The mean QT interval (QTcF) corrected by Fridericia method was≥470 ms；\n\n    ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before the first administration; (4) There is heart failure or LVEF less than 50% with the NYHA cardiac function classification ≥II or structural heart disease with high risk judged by other researchers;\n\n    ⑤ Clinically uncontrollable hypertension.\n17. Suffering from active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), with the exception of clinically stable autoimmune thyroiditis, type I diabetes, vitiligo, cured atopic dermatitis in children, psoriasis that does not require systemic treatment (within the past 2 years), etc.\n18. Suffering from other malignant tumors within 5 years before the start of study administration, except for the following cases: malignant tumors that can be expected to be cured after treatment (including but not limited to thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer or breast ductal carcinoma in situ treated by radical surgery).\n19. There is clinically uncontrollable effusion in the third space, which is judged by the researcher to be unsuitable for the group.\n20. Known alcohol or drug dependence.\n21. Have mental disorder or poor compliance.\n22. Pregnant or lactating women.\n23. The researcher thinks that the subject has other serious history of systemic diseases, or is not suitable to participate in this clinical study for other reasons.",{"count":188,"type":21},60,[24,25],"Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R\u002FM HNSCC\u002FNPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy.\n\nPhase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R\u002FM NPC who failed or progressed after treatment with ≤2-line system.",[192,193,194,195],"NPC","HNSCC","Recurrence","Metastasis",[192,193,194,195],"2024-12-02",{"date":199,"type":37},"2024-12-05",{"date":201,"type":21},"2025-01-01",{"date":203,"type":21},"2028-01-01",{"name":43,"class":44},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":163,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":72},"100533286","phase-1-a-clinical-trial-to-evaluate-effect-of-iap0971-in-patients-with-advanced-malignant-tumors-100533286","NCT06223841","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":212,"type":21},50,[58,24],"This is a Phase Ib\u002FII Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.",[149],"2024-02-18",{"date":218,"type":37},"2024-02-20",{"date":220,"type":21},"2024-03-01",{"date":222,"type":21},"2027-03-01",{"name":43,"class":44},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":4},"100535756","phase-1-a-study-of-iap0971-in-combination-with-bacillus-calmette-guerin-in-high-risk-non-muscular-invasive-bladder-cancer-100535756","NCT06255964","A Study of IAP0971 in Combination With Bacillus Calmette Guerin in High Risk Non-muscular Invasive Bladder Cancer","A Phase I\u002FII Clincal Trial of Intravesical IAP0971 in Combination With Bacillus Calmette Guerin (BCG) in Patients With BCG Unresponsive High Risk Non-Muscular Invasive Bladder Cancer (NMIBC)","Inclusion Criteria:\n\n1. Age ≥ 18 years on the day of signing informed consent form.\n2. Patients who have NMIBC which is confirmed by cystoscopy, urine cytology and histopathology examination within 12 weeks prior to the first dose, and is classified as high risk according to the Guideline of Non-muscle Invasive Bladder Cancer issued by European Association of Urology (EAU) (version 2021)\n3. CIS patients must have CIS on the tumor sample from the most recent cystoscopy\u002FTURBT.\n4. Patients who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:\n\n   -Attainment of a visually complete resection of all papillary tumors (Ta and T1);\n\n   -Residual CIS, therefore not amenable to complete transurethral resection is acceptable;\n   * The most recent cystoscopy\u002FTURBT must have been performed within 12 weeks prior to the first dose.\n5. Patients who have received and failed BCG intravesical instillation therapy prior to enrollment and are ineligible for radical cystectomy or elect not to undergo the procedure.\n\n   Failure of BCG therapy including: BCG refractory tumor, BCG relapsing tumor, BCG unresponsive tumor\n6. Patients who have elected not to undergo the radical cystectomy or are ineligible for the procedure on the investigator's judgment. The reasons for ineligible or refusal of radical cystectomy should be discussed with the patient as part of the informed consent and should be documented on the appropriate case report form. Ineligibility factors for radical cystectomy include, but are not limited to:\n\n   -Patients have cardiovascular disease (e.g., recent acute coronary syndrome, cardiac arrhythmias, heart failure);\n\n   -Patients have chronic obstructive pulmonary disease that would preclude a safe surgical procedure, as determined by the treating surgeon;\n\n   -Patients have undergone major abdominal and pelvic surgery that would preclude a safe surgical procedure, as determined by the treating surgeon.\n7. Patients who have a performance status of 0 or 1 on the ECOG performance scale\n8. Adequate organ function during the screening period, include:\n\n   -Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n\n   -Hemoglobin (Hgb) ≥ 80 g\u002FL;\n\n   -Platelets (PLT) ≥ 100 × 10\\^9\u002FL;\n\n   -ALT and AST ≤ 2.5 × ULN, or ≤ 5.0 × ULN for subject with liver metastases;\n   * Total bilirubin (TBIL) ≤ 1.5×ULN;\n   * Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 30 mL\u002Fmin according to the Cockcroft Gault formula\n   * All premenopausal women and women within 12 months of menopause with a negative serum pregnancy test;\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy. Patients should be waited for at least 1 week to do the above tests if they have received thrombopoietin and\u002For granulocyte colony-stimulating factor.\n9. Expected survival time of more than 6 months\n10. Eligible patients of childbearing potential (men and women) must agree to use a reliable method of contraception (including intrauterine device, contraceptive or condom for females; condom or abstinence for males) with their partners prior to the study entry, during the trial, and for at least 180 days after completion of treatment. In addition, female patients should be non-lactating.\n11. Patients must be informed of the study prior to the trial and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients who are known allergy or intolerance to investigational product, BCG or excipients.\n2. Patients who have muscle-invasive bladder cancer (T2-T4) confirmed.\n3. Patients who have concurrent extra-vesical (i.e., urethral, ureter or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium.\n4. Patients who have a history of vesicoureteral reflux.\n5. Patients who have not recovered from toxicity reactions associated with prior antitumor therapy except for fatigue and alopecia (determination criteria: toxicity remains \\> Grade 1 or has not returned to baseline levels).\n6. Patients who have severe or uncontrollable cardiac diseases which need to be treated, including:\n\n1). patients with severe arrhythmias (ventricular arrhythmias which requires clinical intervention, second to third degree of atrioventricular block, etc.); 2). patients with a medical history of myocardial infarction, unstable angina, angioplasty, or coronary artery bridging surgery within 6 months prior to the first dose of the investigational product; 3). patients with Class III or IV of congestive heart failure classified by NYHA 4). corrected QTc interval is \\> 450 ms for men and \\> 470 ms for women (calculated by the Fridericia formula) by 12-lead ECG at screening.\n\n7\\. Patients who have received intravesical instillation therapy within 28 days prior to the first dose (patients are allowed to have immediate chemotherapeutic instillation in the past and after the current electrodesiccation); 8. Patients who have received antitumor therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy and herbal medicine within 28 days or 5 half-lives of the drug (whichever is longer) prior to the first dose.\n\n9\\. Patients who have participated in any other clinical trial (except for patients at overall survival follow-up) within 28 days or 5 half-lives of the drug (whichever is longer) prior to the first dose.\n\n10\\. Patients who have additional malignancy that have had progression or requires active treatment in the last 3 years. Exceptions include, but are not limited to, in situ cervical cancer, superficial or non-invasive bladder cancer, basal cell carcinoma, in situ squamous cell carcinoma, or gastrointestinal tumors confined to the mucosal layer and that have been endoscopically resected.\n\n11\\. Patients who have received allogeneic stem cell or solid organ transplantation.\n\n12\\. Patients who have received any live\u002Fattenuated vaccine within 4 weeks or blood transfusion within 2 weeks prior to enrollment. 13. Patients who have received extensive radiotherapy to the pelvis (\\> 30% of the bone marrow area).\n\n14\\. Patients who have an active autoimmune disease that have required systemic therapy in the past 2 years (i.e., with use of corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.\n\n15\\. Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the planned first dose. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor.\n\n16\\. Patients who have serious or poorly controlled disease, including but not limited to:\n\n1. . active tuberculosis (with clinical signs, physical examination findings or radiographic findings of active tuberculosis);\n2. . hepatitis B virus (HBV) infection with HBV DNA positive (\\>upper limit of detection values in the site), hepatitis C virus (HCV) infection with HCV RNA positive (\\>upper limit of detection values in the site), and human immunodeficiency virus (HIV) test positive;\n3. . uncontrolled hypertension after treatment (defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n4. . severe and uncontrollable pulmonary disease (severe infectious pneumonia, interstitial lung disease, etc.) (≥Grade 3, CTCAE);\n5. . uncontrolled all types of serious infections (≥Grade 3, CTCAE), including active or refractory urinary tract infections.\n6. . ascites, pleural effusion or pericardial effusion requiring drainage prior to first study drug therapy.\n\n17\\. Patients with known history of psychiatric disorder, substance abuse, drug and alcohol use that would interfere with the subject's ability to cooperate with the requirements of the trial.\n\n18\\. Patients who are inappropriate for participation in this trial in the opinion of the investigator.",{"count":232,"type":21},236,[58,24],"The efficacy and safety of IAP0971 single drug or combined with BCG intravesical instillation in the treatment of high-risk non muscle invasive bladder cancer with BCG treatment failure.",[236],"Bladder Cancer","2024-02-04",{"date":239,"type":37},"2024-02-13",{"date":241,"type":21},"2024-02-15",{"date":243,"type":21},"2026-12-07",{"name":43,"class":44},""]