[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hinova Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":116},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,69,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100616664","phase-2-a-trial-to-evaluate-the-efficacy-safety-pk-and-pd-of-hp515-in-non---alcoholic-fatty-liver-disease--nashmash--100616664",false,"NCT07308548","A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH\u002FMASH )","A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease","NASH\u002FMASH","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions.\n2. Participants must be aged between 18 and 65 years old, including those at the borderline age.\n3. At the screening stage, the liver fat fraction must be ≥ 10%\n4. Female participants must not donate eggs from the start of the screening until the end of the study and within 28 days after discontinuing the study drug; male participants must not donate sperm from the start of the screening until the end of the study and within 28 days after discontinuing the study drug.\n5. Participants must agree to use contraception during the study period and for the next 6 months after the last administration of the study drug, and must agree to continuously use effective contraceptive measures.\n\nExclusion Criteria:\n\n1. The participants have known or suspected allergic reactions\n2. Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis\n3. Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%);\n4. Suspected other liver and gallbladder diseases through medical history and laboratory tests, which, based on the investigator's judgment, may affect safety or efficacy evaluation\n5. Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease\n6. Within the previous 1 year, had myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack, or other cardiovascular and cerebrovascular events that led to hospitalization;\n7. History of liver transplantation or planning to undergo liver transplantation;\n8. Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%;\n9. Participants who used drugs that changed the activity of CYP2C8 of liver enzymes within 4 weeks or 5 half-lives (whichever is longer), including strong inhibitors and inducers of liver metabolic enzymes;\n10. Pregnant or lactating women;\n11. Participants with contraindications to MRI scans;\n12. Participants judged by the investigator to be unsuitable for participation in the study.","ALL","18 Years","65 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Primary Objective:\n\n• To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease.\n\nSecondary objectives:\n\n* To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver disease;\n* To evaluate the pharmacokinetic of HP515 tablets in participants with non-alcoholic fatty liver disease;\n* To evaluate the pharmacodynamic effects of HP515 tablets in participants with non-alcoholic fatty liver disease;\n\nExploratory objective:\n\n• To evaluate the impact of HP515 tablets on target markers in participants with non-alcoholic fatty liver disease.\n\nThe study includes a screening period of 4 weeks, a treatment period of 12 weeks, and a safety follow-up period of 4 weeks.",[28],"NAFLD (Non-alcoholic Fatty Liver Disease)",[30,31],"non-alcoholic","Fatty Liver","RECRUITING","2025-12-19",{"date":35,"type":36},"2025-12-29","ACTUAL",{"date":38,"type":36},"2025-10-11",{"date":40,"type":22},"2026-12-31",{"name":42,"class":43},"Hinova Pharmaceuticals Inc.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100528001","phase-1-a-study-to-assess-the-safety-pharmacokinetics-and-anti-tumor-activity-of-oral-hp518-in-mcrpc-patients-100528001","NCT06155084","A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients","A Phase I\u002FII Open-Label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer in China","Inclusion Criteria:\n\n1. Male, age ≥18\n2. Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)\n3. Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics.\n4. Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT\u002FMRI at the beginning of study.\n5. the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.\n6. Must have recovered from toxicities related to any prior treatments\n7. Ongoing ADT with LHRH agonist\u002Fantagonist therapy or history of bilateral orchiectomy.\n8. ECOG performance status score of 0 to 1.\n\nExclusion Criteria:\n\n1. Combination of research or commercially available drugs targeting AR\n2. Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.\n3. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).\n4. Has significant cardiovascular disease.","MALE",{"count":54,"type":22},84,[56,25],"PHASE1","The overall objective of this Phase 1 study is to evaluate the safety, PK,and anti-tumor activity of daily oral dosing with HP518,selecting the RP2D of HP518 based on assessments of patients with progressive mCRPC in dose-escalation phase",[59],"Metastatic Castration-resistant Prostate Cancer","2025-12-16",{"date":62,"type":36},"2025-12-22",{"date":64,"type":36},"2023-12-26",{"date":66,"type":22},"2026-09",{"name":42,"class":43},27,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100351117","phase-3-a-trial-evaluating-the-efficacy-and-safety-of-hc-1119-soft-capsules-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100351117","NCT03851640","A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).","A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Failed Treatments with Abiraterone Acetate and Docetaxel.","Inclusion Criteria:\n\n1. Males aged ≥18 years at screening and voluntary to participate in the study and sign the informed consent form.\n2. Subjects with histologically or cytologically confirmed prostate adenocarcinoma, with no small cell features.\n3. In the case of medical or surgical castration, during or after the last treatment before screening, there are signs of progressive disease determined according to the PCWG3 criteria, defined as satisfying one or more of the following 3 criteria:\n\n   1. PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg\u002FL (1 ng\u002FmL) in the screening period;\n   2. Progression of soft tissue lesions as defined by RECIST 1.1;\n   3. The progression of bone lesions is defined as at least two new lesions discovered by bone scan; ambiguous results can be confirmed using another imaging technique (e.g., CT or MRI).\n4. Metastatic diseases confirmed by imaging examinations during the screening period (the status of metastasis refers to the presence of metastatic lesions confirmed by bone scan and\u002For CT\u002FMRI scan).\n5. For patients who have undergone orchiectomy or are being treated by medical castration therapy, their androgen blockade therapy is maintained by luteinizing hormone-releasing hormone agonists or antagonists during the study period (including the follow-up period), and their serum testosterone levels are ≤ 1.73 nmol\u002FL (50 ng\u002FdL) during screening visits.\n6. Patients who have failed previous treatments of prostate cancer with abiraterone acetate or who are intolerant to treatments with abiraterone acetate.\n7. Patients who have failed previous chemotherapy of prostate cancer with docetaxel or who are intolerant to treatments with docetaxel, or who are not suitable for docetaxel treatment during screening. Patients who are not suitable for docetaxel treatment during screening and do not plan to use cytotoxic chemotherapy within 6 months after the informed discussion are eligible.\n8. Expected survival of ≥ 3 months.\n9. ECOG performance status score of 0-2.\n10. Laboratory tests must meet the following criteria:\n\n    1. Blood routine examination: Hemoglobin (Hb) ≥ 85 g\u002FL; white blood cell (WBC) ≥ 3.0 x 109\u002FL; platelet (PLT) ≥ 75 x 109\u002FL;\n    2. Liver function: Total bilirubin (TBIL) ≤ 1.5 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (for patients without liver metastasis) or ≤ 5 x ULN (for patients with liver metastasis); albumin (ALB) ≥ 25 g\u002FL;\n    3. Renal function: serum creatinine (SCr) ≤ 1.5 x ULN.\n11. Willing to use reliable contraceptive measures (such as condoms) and not to donate sperms throughout the study period and within 3 months after the last dose.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions should not be enrolled:\n\n1. Received any anti-prostate cancer treatment within 4 weeks before randomization, including chemotherapy, immunotherapy, targeted therapy, estrogen therapy, anti-androgen therapy, systemic radiotherapy, treatments with traditional Chinese medicines for anticancer, or treatments with interventional drugs of other clinical trials; palliative radiotherapy or surgery for bone metastatic or soft tissue lesions should be completed \\>14 days prior to baseline imaging examinations; the lesions treated by palliative radiotherapy should not be the targeted lesions of subsequent RECIST 1.1 assessment. Androgen blockade therapy that is maintained by a luteinizing hormone releasing hormone agonist or antagonist.\n2. Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).\n3. Patients with brain or central nervous system metastases are known (if a brain or central nervous system metastasis is suspected, a CT\u002FMRI scan of the head is required)\n4. Patients with known serious cardiovascular diseases, including any of the following:\n\n   1. A myocardial infarction or thrombotic event occurred in the past 6 months;\n   2. Known unstable angina;\n   3. Heart failure of Grade III or IV according to the New York Heart Association (NYHA) criteria;\n   4. QT interval of \\> 500 ms during screening visits;\n   5. Resting systolic blood pressure of \\>170 mmHg or diastolic blood pressure of \\>105 mmHg suggesting uncontrolled hypertension during screening visits.\n5. The toxicity of previous treatment has not been eliminated before the start of the study treatment; toxic reaction of grade 2 or above (except for hair loss) according to the CTCAE 5.0 grading scale remains.\n6. Clinically significant gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (for example, inability to swallow, chronic diarrhea or intestinal obstruction, and patients had total gastrectomy).\n7. Patients with a history of serious diseases in the central nervous system. Patients with a history of epilepsy or any history of diseases that may induce epilepsy, including unexplained loss of consciousness or transient ischemic attack.\n8. Patients who have been diagnosed in the past 5 years with other malignant tumors in addition to prostate cancer, except patients with cured basal or squamous cell skin cancer and superficial bladder tumors (Ta, Tis, and T1).\n9. Patients with a history of allogeneic bone marrow or organ transplantation who require continued medical treatment.\n10. Patients with known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis or other active infections.\n11. Patients known to be allergic to androgen receptor inhibitors.\n12. The investigator believes that the patients are unfit for this study (e.g., the treatments will not benefit the patients the most, inadequate patient compliance, etc.).",{"count":77,"type":22},417,[79],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.",[82],"MCRPC","2025-03-10",{"date":85,"type":36},"2025-03-12",{"date":87,"type":36},"2019-04-12",{"date":89,"type":22},"2025-09",{"name":42,"class":43},1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":99,"minAge":18,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100574288","phase-1-a-phase-iii-trial-to-evaluate-oral-hp568-tablets-in-patients-with-erher2-advanced-breast-cancer-100574288","NCT06757335","A Phase I\u002FII Trial to Evaluate Oral HP568 Tablets in Patients with ER+\u002FHER2 Advanced Breast Cancer","A Multicenter, Open, Dose Escalation\u002Fdose Escalation, and Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral HP568 Tablets Alone and in Combination with Palbociclib in Patients with ER+\u002FHER2 Advanced Breast Cancer","Inclusion Criteria:\n\n1. Women aged 18-75 years old (inclusive of both ends) at the time of signing the informed consent form.\n2. Patients with locally advanced inoperable or recurrent or metastatic breast cancer ER+\u002FHER2- advanced breast cancer is confirmed by histopathology have confirmed that the primary and\u002For metastatic lesion.\n3. Previously received at least 1-line endocrine therapy (endocrine therapy duration ≥ 6 months) and ≤ 2-line chemotherapy (≤ 2-line chemotherapy limited to dose escalation stage) for the recurrence or metastasis stage of the disease. The third stage : Inclusion of patients who have not received prior treatment but are suitable for CDK4\u002F6i therapy.\n4. Disease progression confirmed by imaging occurs during or after the last systemic anti-tumor treatment before the first medication.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to any ingredient of HP568 formulation, and allergy to any ingredient of palbociclib (only applicable to stage III).\n2. Within 42 days prior to the first administration, Fluvistran was used; Other endocrine therapies such as tamoxifen, toremifene, letrozole, anastrozole, and exemestane were used within 14 days prior to the first administration.\n3. Previously received other ER-ROTAC drugs such as ARV-471.\n4. Within 6 weeks before the first administration of HP568 in this study, nitrosoureas or mitomycin were used; Received any anti-tumor treatment, including immunotherapy, chemotherapy, radiotherapy, or targeted therapy, within 28 days prior to the first administration (or of the drug's 5 half lives,take the shorter one).","FEMALE","75 Years",{"count":102,"type":22},204,[56,25],"This is a Phase 1\u002F2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+\u002FHER2- locally advanced or metastatic breast cancer.",[106],"Breast Cancer","NOT_YET_RECRUITING","2025-01-01",{"date":110,"type":36},"2025-01-03",{"date":112,"type":22},"2025-01-07",{"date":114,"type":22},"2026-11-27",{"name":42,"class":43},""]