[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TYK Medicines, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":208},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,64,80,102,124,146,168,189],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100614690","phase-1-study-of-tyk-01054-capsules-in-patients-with-advanced-solid-tumors-100614690",false,"NCT07282873","Study of TYK-01054 Capsules in Patients With Advanced Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of the TEAD Inhibitor TYK-01054 Capsules in Patients With Locally Advanced or Metastatic Advanced Solid Tumors","Inclusion Criteria:\n\n1. Male or female subjects ≥18 years old\n2. Histologically or cytologically confirmed incurable, locally advanced or metastatic advanced solid tumors. All participants are required to provide results of Hippo signaling pathway gene testing; however, this requirement is not a mandatory inclusion criterion for Dose Escalation (Part A) and EHE patients.\n3. Advanced solid tumors must have progressed after receiving at least one standard first-line anti-tumor therapy, OR demonstrate intolerance to standard therapy, OR Lack of standard treatment.\n4. Patients should have at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1.\n5. Adequate organ function, including hepatic, renal, cardiovascular, astrointestinal,respiratory, and hematopoietic systems.\n6. ECOG 0-1，\n7. Life expectancy of \\>3 months.\n8. Willing and able to comply with all aspects of the protocol.\n\nExclusion Criteria:\n\n1. History of other malignancy, except for:\n\n   Non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) that is non-invasive and has been effectively controlled with no recurrence or metastasis for 5 years, Papillary thyroid carcinoma, Carcinoma in situ of the cervix, Ductal carcinoma in situ of the breast.\n2. Unstable brain metastases,such as:\n\n   Patients requiring urgent neurosurgical intervention for CNS complications, Presence of symptomatic spinal cord compression due to tumor, Presence of leptomeningeal disease (carcinomatous meningitis).\n3. Presence of pleural effusion, pericardial effusion, or ascites that, in the investigator's judgment, cannot be stably controlled by repeated drainage or other methods.\n4. Clinically significant renal disease.\n5. Clinically significant cardiovascular disease, including but not limited to myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), or uncontrolled arrhythmias.\n6. Patients with uncontrolled infectious diseases, such as immunodeficiency disorders (e.g., HIV) or active hepatitis B or C infection; chronic hepatitis B or C carriers without symptoms are excluded from this criterion.\n7. Known or suspected hypersensitivity to TYK-01054 or any of its excipients, or to compounds of similar chemical class.\n8. Patients who have previously received a TEAD inhibitor.\n9. Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":19,"type":20},219,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study is to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of the TEAD inhibitor TYK-01054 capsules in patients with locally advanced or metastatic advanced solid tumors",[27,28],"Solid Tumor Malignancies","Malignant Mesothelioma (MM)","NOT_YET_RECRUITING","2025-12-15",{"date":32,"type":33},"2025-12-22","ACTUAL",{"date":35,"type":20},"2026-01-01",{"date":37,"type":20},"2029-06",{"name":39,"class":40},"TYK Medicines, Inc","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100600988","phase-1-study-of-tyk-00540-combined-with-enzalutamide-in-patients-with-metastatic-castration-resistant-prostate-cancermcrpc-100600988","NCT07104643","Study of TYK-00540 Combined With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of TYK-00540 Combined With Enzalutamide in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Previous Novel Endocrine Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrence and metastasis (such as in the bladder, rectum, etc.) cannot be included.\n3. At the time of screening, testosterone levels were at castration levels (≤50ng\u002FdL or 1.70nmol\u002FL). If the patient had not previously undergone bilateral orchiectomy, they must be undergoing and voluntarily continue to receive LHRH agonists\u002Fantagonists for androgen deprivation therapy throughout the study treatment period.\n4. During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA \\> 1ng\u002Fml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.\n5. Previous anti-tumor treatment must meet the following requirements: having failed in only one approved and marketed novel endocrine therapy in the past (referring to disease progression during the process of novel endocrine therapy; The definition of disease progression is the same as that in inclusion criterion 4), such as abiraterone acetate, apatamide, darotamide or rivelutamide, etc., and no treatment with enzalutamide has been received.\n6. ECOG score ≤1, no deterioration in the two weeks prior to study enrollment, and an expected survival period of ≥3 months\n7. Have good organ functions, including:\n\n   1. Liver function Total bilirubin (TBIL) ≤ 1.5×ULN (except for documented Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5×ULN, and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, ALT\u002FAST≤5×ULN), albumin ≥3.0g\u002FL;\n   2. Renal function enhancement: Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate ≥50 mL\u002Fmin;\n   3. \\\u003CS:1\\> Blood routine: PLT ≥ 100×109\u002FL, ANC ≥ 1.5×109\u002FL, WBC≥ 3.5×109\u002FL and Hb ≥ 90g\u002FL;\n   4. The international normalized ratio (INR) is ≤1.5, and the activated partial prothrombin time (APTT) is ≤1.5×ULN;\n8. The patient agrees to maintain abstinence (control heterosexual sexual intercourse) or take contraceptive measures, and agrees not to donate sperm;\n9. Understand and voluntarily sign the written ICF, and have the willingness and ability to complete regular visits, treatment plans, laboratory tests and other experimental processes.\n\nExclusion Criteria:\n\n1. Subjects with the following treatments:\n\n   1. Those who have previously received selective CDK2, CDK4 inhibitors, CDK4\u002F6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib\u002FG1T38, SHR6390, pirociclib) for treatment;\n   2. Previously received enzalutamide or two or more novel endocrine therapies for prostate cancer;\n   3. Isotope therapy with strontium-89, samarium or radium-223 was received within 12 weeks prior to the first administration;\n   4. Systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) has been received within 4 weeks prior to the first medication.\n   5. Systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) has been received within 4 weeks prior to the first medication.\n   6. The patient has received blood transfusion, albumin infusion or used hematopoietic growth factor within 2 weeks before the first administration;\n   7. Major surgery was performed within 28 days before the first administration of the drug , or surgery was performed when the surgical effect had not yet recovered at the time of screening or during the planned enrollment for treatment;\n   8. Has received allogeneic transplants such as stem cell transplantation, bone marrow transplantation or liver transplantation in the past;\n   9. Palliative radiotherapy was received within 2 weeks before the first administration;\n   10. The first administration was within no more than five half-lives from the implantation of radioactive particles;\n   11. The first administration was within no more than five half-lives from the implantation of radioactive particles.\n2. In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding those with other malignant tumors who have been cured of radical treatment for ≥5 years;\n3. In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding those with other malignant tumors who have been cured of radical treatment for ≥5 years;\n4. Known to be allergic to any excipients of TYK-00540 tablets, or allergic to enzalutamide and its excipients;\n5. Patients whose progression of bone and soft tissue lesions cannot be evaluated, that is, those who simultaneously meet the following two criteria:\n\n   1. The bone scan shows a super bone imaging.\n   2. According to RECIST1.1 criteria, there are no assessable soft tissue lesions (measurable or unmeasurable).\n6. The patient has any unstable or other disease or medical condition that may affect its safety or compliance with the study, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg), uncontrolled diabetes, active bleeding, ocular lesions Other serious diseases of the mental, nervous and other systems;\n7. Clinically obvious digestive tract abnormalities during screening may affect drug intake, transport or absorption (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcers, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, etc.);\n8. Severe bone injury caused by tumor bone metastasis, with pathological fractures of important parts or spinal cord compression expected to occur in the near future within 6 months prior to knowledge;\n9. There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg\u002F day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included;\n\n9\\. There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg\u002F day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included 10.Patients with clinically symptomatic third space effusion (such as pleural effusion, ascites, pericardial effusion) who require puncture and drainage, or those who have received puncture and drainage within 2 weeks before the first medication; 11. At the time of screening, the toxicity of previous treatments had not yet recovered. According to CTCAE v5.0, there were still grade ≥2 AES (excluding special toxicities such as alopecia, fatigue, increased GGT, and increased ALP).\n\n12\\. Have serious cardiovascular diseases, including but not limited to:\n\n1. At rest, the 12-lead electrocardiogram examination showed that the QTcF was ≥470ms.\n2. There are severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.\n3. Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA)) cardiac function grade ≥2, aortic dissection or other grade 3 cardiovascular events occurred within 6 months before the first administration.\n4. Left ventricular ejection fraction (LVEF) \\\u003C50%; 13. There is a history of thromboembolism or cerebrovascular events within 6 months before the first administration, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis or pulmonary embolism, etc; 14. There was evidence of radiation pneumonitis, interstitial lung disease or interstitial pneumonia (ILD) requiring hormone therapy during the screening period, or drug-induced ILD, or any active ILD (such as acute exacerbation or progressive pneumonia\u002Fpulmonary fibrosis at baseline). Or pulmonary symptoms that the researchers consider unsuitable for enrollment, or high-risk factors that make it unsuitable for enrollment due to the possibility of interstitial lung disease; 15.Severe infection occurred within 4 weeks before the first administration, including but not limited to bacteremia and severe pneumonia that require hospitalization; There was an active infection of CTCAE grade ≥2 that required systemic antibiotic treatment within 2 weeks before the first administration (except for local chronic infections or prophylactic antibiotic use that the investigator determined did not require treatment).\n\n   16\\. Those with a history of active pulmonary tuberculosis infection within 6 months prior to the first administration; 17. People infected with active human immunodeficiency virus (HIV), syphilis, hepatitis C virus (HCV) or hepatitis B virus (HBV). Active HBV, HCV and HIV infections are defined as:\n\na.positive HBsAg and HBV DNA ≥500cps\u002Fml\u002FHBV DNA ≥1000u\u002Fml; b.Anti-hcv antibody and HCV RNA positive; c.HIV antibody positive. 18. Known history of alcohol or drug abuse or dependence; Mental disorder; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make the participants unsuitable for this study (such as not meeting the most beneficial treatment for the subjects, subject compliance, etc.)","MALE",{"count":51,"type":20},48,[23,24],"This study is to evaluate the safety, and preliminary antitumor activity of TYK-00540 combined with Enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy",[55],"mCRPC","2025-07-29",{"date":58,"type":33},"2025-08-05",{"date":60,"type":20},"2025-08",{"date":62,"type":20},"2026-11",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":79,"locationsCount":41},"100600986","phase-1-study-of-ty-302-capsules-combined-with-abiraterone-in-patients-with-metastatic-castration-resistant-prostate-cancermcrpc-100600986","NCT07104617","Study of TY-302 Capsules Combined With Abiraterone in Patients With Metastatic Castration-resistant Prostate Cancer（mCRPC）","A Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of Oral TY-302 Capsules Combined With Abiratone Acetate Tablets in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC) That Has Failed Novel Endocrine Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Metastatic castration-resistant prostate adenocarcinoma confirmed by pathology (with no neuroendocrine or small cell features indicated by the initial pathological examination), if pathological examination is performed in the subsequent CRPC stage, the accompanying other pathological types should not exceed 10%. Those with only pelvic lymph node metastasis or local recurrent metastasis (such as in the bladder, rectum, etc.) cannot be included.\n3. Testosterone levels ≤50ng\u002FdL (≤1.75nmol\u002FL) within 28 days prior to the first administration. If the patient has not undergone bilateral orchiectomy in the past, they must be undergoing and voluntarily continue to receive LHRH agonists\u002Fantagonists for androgen deprivation therapy throughout the study treatment period\n4. During screening, if the disease progresses, that is, the subject experiences one or more of the following three conditions; PSA progression is defined as no PSA \\> 1ng\u002Fml and at least two elevated PSA levels with an interval of ≥1 week. ② Disease progression as defined in RECIST 1.1; ③ Bone disease progression as defined by the PCWG3 standard refers to the discovery of ≥2 new lesions on bone scans.\n5. Previous anti-tumor treatment must meet the following requirements: having failed in only one approved and marketed novel endocrine therapy in the past (referring to disease progression during the process of novel endocrine therapy; The definition of disease progression is the same as that of inclusion criterion 4), such as enzalutamide, apatamide, darotamide or rivelutamide, etc., and no previous treatment with abiraterone acetate has been received.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy \\> 3 months.\n7. Have good organ functions, including:\n\n   Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN (except for documented Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5×ULN, and aspartate aminotransferase (AST) ≤ 2.5×ULN (for patients with liver metastasis, ALT\u002FAST≤5×ULN), albumin ≥3.0g\u002FL; Renal function: Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate ≥50 mL\u002Fmin (calculated according to the Cockcroft and Gault formula); Blood routine: PLT ≥ 100×109\u002FL, ANC ≥ 1.5×109\u002FL, WBC≥ 3.5×109\u002FL and Hb ≥ 90g\u002FL; The international normalized ratio (INR) is ≤1.5, and the activated partial prothrombin time (APTT) is ≤1.5×ULN (in the absence of anticoagulation therapy).\n8. agrees to maintain abstinence (control heterosexual sexual intercourse) or take contraceptive measures, and agrees not to donate sperm\n9. Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).\n\nExclusion Criteria:\n\n1. Patients with the following treatment:\n\n   1. Received CDK4\u002F6 inhibitors (e.g., Palbociclib, Ribociclib, Abemaciclib, Trilaciclib\u002FG1T38, SHR6390, pirociclib) ;\n   2. Received abirone acetate tablets and their analogues (CYP17 inhibitors, such as ketoconazole, etc.) or two or more novel endocrine therapies for prostate cancer;\n   3. Received with strontium-89, samarium or radium-223 within 12 weeks prior to the first administration;\n   4. Received systemic treatment for prostate cancer (anti-androgen therapy, chemotherapy, targeted therapy, immunotherapy, or other interventional clinical trial drugs, except castration therapy drugs) within 4 weeks prior to the first medication;\n   5. Received traditional Chinese medicine preparations with anti-tumor therapeutic effects within one week before the first administration, or those who have received nitrourea or mitomycin treatment within six weeks before the first administration;\n   6. Received blood transfusion, albumin infusion or used hematopoietic growth factor within 2 weeks before the first administration;\n   7. Within two weeks prior to the first administration, the patient has received treatment with drugs prohibited by the protocol \\[such as CYP3A strong suppressors, CYP3A strong inducers, and CYP3A-sensitive substrates with a narrow therapeutic index, etc.\\];\n   8. Major surgery was performed within 28 days before the first administration of the drug , or surgery was performed when the surgical effect had not yet recovered at the time of screening or during the planned enrollment for treatment;\n   9. Has received allogeneic transplants such as stem cell transplantation, bone marrow transplantation or liver transplantation in the past;\n   10. Palliative radiotherapy was received within 2 weeks before the first administration;\n   11. The first administration was within no more than five half-lives from the implantation of radioactive particles.\n2. In addition to prostate cancer, there are other malignant tumors at the same time (excluding basal cell carcinoma or squamous cell carcinoma of the skin that can be treated locally and have been cured, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma of the breast and papillary thyroid carcinoma, etc.); Excluding other malignant tumors that have been cured by radical treatment for at least 5 years;\n3. There is previous evidence indicating the existence of homologous recombination gene mutations (such as BRCA1, BRCA2, etc.)\n4. Known to be allergic to any excipients of TY-302 Capsules, or to Abiraterone acetate tablets and their excipients;\n5. There are contraindications for the use of prednisone (corticosteroid), such as active infection, active peptic ulcer, recent gastrointestinal anastomosis surgery, fracture, wound healing period, corneal ulcer, severe osteoporosis or other conditions. Or there may be diseases that require treatment with systemic steroid hormones (i.e., other corticosteroids at a physiological dose of more than 10mg\u002F day, such as prednisone or similar drugs);\n6. Patients whose progression of bone and soft tissue lesions cannot be evaluated, that is, those who meet both of the following criteria simultaneously:\n\n   1. The bone scan showed a super bone imaging;\n   2. According to RECIST1.1 criteria, there were no assessable soft tissue lesions (measurable or unmeasurable).\n7. The patient has any unstable or other disease or medical condition that may affect its safety or compliance with the study, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥95 mmHg), uncontrolled diabetes, active bleeding, ocular lesions Other serious diseases of the mental, nervous and other systems;\n8. Clinically obvious digestive tract abnormalities during screening may affect drug intake, transport or absorption (such as dysphagia, uncontrollable nausea and vomiting, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, etc.);\n9. Severe bone injury caused by tumor bone metastasis, with pathological fractures of important parts or spinal cord compression expected to occur in the near future within 6 months prior to knowledge;\n10. There is cancerous meningitis or untreated central nervous system metastasis. Those who have previously received systemic or radical treatment for brain metastases (radiotherapy or surgery), and whose stability has been maintained for at least one month as confirmed by imaging, and who have stopped systemic hormone therapy (with a dose greater than 10mg\u002F day prednisone or other equivalent dose hormones) for more than two weeks and have no clinical symptoms, can be included;\n11. Patients with clinically symptomatic third space effusion (such as pleural effusion, ascites, pericardial effusion) who require puncture and drainage, or those who have received puncture and drainage within 2 weeks before randomization or the first medication;\n12. At the time of screening, the toxicity of previous treatments had not yet recovered. According to CTCAE v5.0, there were still grade ≥2 AES (excluding special toxicities such as alopecia, fatigue, increased GGT, and increased ALP);\n13. Have severe cardiovascular diseases, including but not limited to:\n\n    1. At rest, a 12-lead electrocardiogram (ECG) examination showed that the QTcF was ≥470ms;\n    2. There are severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc;\n    3. Acute coronary syndrome, congestive heart failure (New York Heart Association (NYHA)) cardiac function grade ≥2, aortic dissection or other grade 3 cardiovascular events occurred within 6 months before the first administration;\n    4. Left ventricular ejection fraction (LVEF) \\\u003C50%;\n14. There is a history of thromboembolism or cerebrovascular events within 6 months before the first administration, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis or pulmonary embolism, etc;\n15. There was evidence of radiation pneumonitis, interstitial lung disease or interstitial pneumonia (ILD) requiring hormone therapy during the screening period, or drug-induced ILD, or any active ILD (such as acute exacerbation or progressive pneumonia\u002Fpulmonary fibrosis at baseline). Or pulmonary symptoms that the researchers consider unsuitable for enrollment, or high-risk factors that make it unsuitable for enrollment due to the possibility of interstitial lung disease;\n16. There was a severe infection within 4 weeks before the first administration, including but not limited to bacteremia requiring hospitalization and severe pneumonia; There was an active infection of CTCAE grade ≥2 that required systemic antibiotic treatment within 2 weeks before the first administration (except for local chronic infections or prophylactic antibiotic use that the investigator determined did not require treatment);\n17. Those with a history of active pulmonary tuberculosis infection within 6 months prior to the first administration;\n18. People infected with active human immunodeficiency virus (HIV), syphilis, hepatitis C virus (HCV) or hepatitis B virus (HBV). Active HBV, HCV and HIV infections are defined as:\n\n    1. positive HBsAg and HBV DNA ≥500cps\u002Fml\u002FHBV DNA ≥1000u\u002Fml;\n    2. Anti-hcv antibody and HCV RNA positive;\n    3. HIV antibody positive.\n19. Known history of alcohol or drug abuse or dependence; Mental disorder; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make the participants unsuitable for this study (such as not meeting the most beneficial treatment for the subjects, subject compliance, etc.).",{"count":51,"type":20},[23,24],"This study is to evaluate the safety, and preliminary antitumor activity of TY-302 combined with Abiraterone tablets in patients with metastatic castration-resistant prostate cancer (mCRPC) that have failed novel endocrine therapy",[75],"Metastatic Castration-resistant Prostate Cancer (mCRPC)",{"date":58,"type":33},{"date":60,"type":20},{"date":62,"type":20},{"name":39,"class":40},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":101},"100589105","phase-1-study-of-tyk-00540-tablets-in-patients-with-advanced-solid-tumors-100589105","NCT06950086","Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2\u002F4\u002F6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years, gender requirements:\n\n   Monotherapy dose-escalation phase: No gender restriction.\n\n   Combination dose-selection phase: No gender restriction.\n\n   Monotherapy and combination expansion phases:\n\n   Cohort A-1: Females only.\n\n   Other cohorts: No gender restriction.\n\n   Monotherapy Dose-Escalation Phase:\n2. Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumors with no standard treatment available, failure of\u002Fintolerance to standard treatment, or refusal of standard treatment.\n\n   Monotherapy Dose-Expansion Phase:\n\n   Cohort A-1: Histologically or cytologically confirmed advanced platinum-resistant epithelial ovarian cancer (EOC)\u002Ffallopian tube cancer\u002Fprimary peritoneal cancer:\n\n   Platinum resistance defined as: Disease recurrence\u002Fprogression \\\u003C6 months after completion of prior platinum-based chemotherapy (≥4 cycles) or progression during initial\u002Frecurrent treatment.\n\n   Disease recurrence\u002Fprogression requires:\n   1. Objective radiographic progression; OR\n   2. Persistent CA125 elevation (confirmed after 1 week) with clinical symptoms or signs of progression.\n\n      * 3 prior lines of chemotherapy for recurrent\u002Fmetastatic disease, with ≤1 systemic therapy after platinum resistance.\n\n   Cohort A-2: HR+\u002FHER2- advanced breast cancer with confirmed resistance to CDK4\u002F6 inhibitors (≥1 documented instance).\n\n   Combination Dose-Selection Phase:\n\n   HR+\u002FHER2- advanced breast cancer with confirmed resistance to CDK4\u002F6 inhibitors (≥1 documented instance).\n\n   Combination Dose-Expansion Phase:\n\n   Cohort B-1: HR+\u002FHER2- advanced breast cancer with prior endocrine therapy resistance and either:\n\n   No prior CDK4\u002F6 inhibitor treatment; OR\n\n   CDK4\u002F6 inhibitor-treated in the adjuvant setting with recurrence \\>1 year after completion (no confirmed resistance).\n\n   Cohort B-2: HR+\u002FHER2- advanced breast cancer with progression during\u002Fafter endocrine + CDK4\u002F6 inhibitor therapy:\n\n   For adjuvant CDK4\u002F6 inhibitor resistance: Recurrence during or ≤1 year after treatment;\n\n   ≥1 documented CDK4\u002F6 inhibitor resistance.\n\n   Note for Cohorts A-2, Combination Dose-Selection, and Combination Expansion Phases:\n   * 2 prior endocrine therapy regimens for recurrent\u002Fmetastatic disease (adjuvant endocrine therapy leading to recurrence within 1 month of completion counts as 1 regimen).\n   * 1 prior chemotherapy or ADC regimen for recurrent\u002Fmetastatic disease.\n\n   Prior CDK4\u002F6 inhibitor use:\n   1. Duration ≥6 months;\n   2. Adjuvant CDK4\u002F6 inhibitor use with progression \\>1 year after completion does not count as resistance;\n   3. Switching CDK4\u002F6 inhibitors due to intolerance is permitted.\n3. For female patients in Combination Phases:\n\n   Meet ≥1 of the following:\n   1. Bilateral oophorectomy;\n   2. Age ≥60 years;\n   3. Age \\\u003C60 years with natural menopause ≥12 months (without chemotherapy, tamoxifen, toremifene, or ovarian suppression in the past year), confirmed by postmenopausal FSH and estradiol levels;\n   4. Age \\\u003C60 years on tamoxifen\u002Ftoremifene with postmenopausal FSH and estradiol levels.\n\n   Non-postmenopausal patients must use LHRH agonists\u002Fantagonists throughout the study.\n4. Baseline Lesions:\n\n   Monotherapy dose-escalation: Extracranial evaluable\u002Fmeasurable lesions.\n\n   Combination phases: Extracranial measurable lesions (RECIST 1.1).\n5. ECOG performance status 0-1, no deterioration within 2 weeks prior to first dose (Appendix II).\n6. Life expectancy ≥3 months.\n7. Adequate Organ Function:\n\n   Liver:TBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN (≤5×ULN for liver metastases; ≤3×ULN for combination with fulvestrant).\n\n   Kidney:Serum creatinine ≤1.5×ULN, creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula, Appendix III).\n\n   Hematology:Platelets ≥90×10\\^9\u002FL, ANC ≥1.5×10\\^9\u002FL, Hb ≥90 g\u002FL (without transfusion\u002FG-CSF within 2 weeks).\n\n   Cardiac:LVEF ≥50% (echocardiogram), QTcF \\\u003C470 ms. Coagulation:INR ≤1.5, APTT ≤1.5×ULN (without anticoagulation).\n8. Contraception:Females of childbearing potential: Negative pregnancy test and commitment to highly effective contraception\u002Fabstinence from screening until 6 months post-treatment (Appendix IV).Males: Commitment to contraception\u002Fabstinence during the same period.For fulvestrant combination: Contraception until 1 year after last dose.\n9. Voluntary signed ICF (or by legal guardian) and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any excipient of TYK-00540 or contraindication to fulvestrant (for Combination Dose-Selection and Combination Expansion Phases).\n2. Prior\u002Fconcurrent therapies:\n\n   Systemic anticancer therapies within 28 days prior to first dose: chemotherapy, large-molecule targeted therapy, immunotherapy.\n\n   Endocrine therapy, small-molecule targeted therapy, or fluorouracil-based oral agents within 14 days prior to first dose.\n\n   Nitrosoureas or mitomycin within 6 weeks prior to first dose. Anticancer herbal medicine or traditional Chinese medicine within 7 days prior to first dose.\n\n   Local radiotherapy (e.g., thoracic\u002Frib) or palliative radiotherapy for bone metastases within 7 days prior to first dose.\n\n   Major surgery (excluding minor procedures, e.g., appendectomy, tumor biopsy) within 4 weeks prior to first dose.\n\n   Proton pump inhibitor (PPI) use within 7 days prior to first dose or during the study.\n\n   Concurrent use of medications known to prolong QTc interval or induce torsades de pointes (Appendix V).\n\n   Participation in other interventional clinical trials within 28 days prior to first dose (non-interventional trials excluded).\n\n   Prior allogeneic bone marrow transplantation. For Combination Phases: prior use of fulvestrant, other SERDs, or SERCAs.\n3. History of other malignancies, except:Cured basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma, ductal carcinoma in situ of the breast, or malignancies with disease-free survival \\>3 years.\n4. Residual toxicity from prior therapy \\>Grade 1 (except alopecia or platinum-related neuropathy).\n5. Central nervous system (CNS) disease:Primary CNS tumors, CNS metastases with prior local treatment failure, or newly diagnosed CNS metastases.Exception: Asymptomatic, stable CNS metastases (no steroids\u002FCNS-specific treatment ≥14 days, radiologically confirmed stability at screening).\n6. Spinal cord compression caused by tumor.\n7. Visceral crisis.\n8. Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage\u002Fmedical intervention (within 14 days prior to first dose).\n9. Clinically significant ECG abnormalities at baseline (e.g., QTc ≥470 ms, complete LBBB, acute\u002Findeterminate-age myocardial infarction, ST-T changes suggesting ischemia, second-\u002Fthird-degree AV block, severe bradycardia\u002Ftachycardia).\n10. Cardiovascular events within 6 months:Myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (sustained ventricular tachycardia\u002Ffibrillation), severe conduction defects (e.g., bifascicular block, third-degree AV block), unstable angina, coronary\u002Fperipheral bypass, symptomatic CHF (NYHA Class III\u002FIV), stroke, TIA, symptomatic pulmonary embolism, or clinically significant thromboembolism.Persistent NCI CTCAE ≥Grade 2 arrhythmia, atrial fibrillation (asymptomatic atrial fibrillation ≥Grade 2).\n\n    Exception: Patients with cardiac pacemakers\u002Fdevices and QTcF \\>470 ms may be eligible after discussion with the medical monitor.\n11. Unstable or uncontrolled medical conditions affecting safety\u002Fcompliance, including:Uncontrolled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg).Uncontrolled diabetes, active bleeding, ocular disease, severe psychiatric\u002Fneurological\u002Fcardiovascular\u002Frespiratory disorders.\n12. Active\u002Funcontrolled infections or immunodeficiencies:Active HBV (HBsAg-positive with HBV DNA ≥2000 copies\u002FmL \\[or 500 IU\u002FmL\\]).Active HCV (HCV antibody-positive with HCV RNA-positive).HIV-positive.Exception: Asymptomatic chronic HBV\u002FHCV carriers.\n13. Lung disease:Radiation pneumonitis requiring steroids, interstitial lung disease (ILD)\u002Fpneumonitis (active or drug-induced), acute\u002Fprogressive pulmonary fibrosis, or high-risk factors for ILD per investigator judgment.\n14. Clinically significant gastrointestinal disorders affecting drug absorption (e.g., dysphagia, uncontrolled vomiting, active ulcers, inflammatory bowel disease, chronic diarrhea, bowel obstruction, chronic PPI-dependent conditions).\n15. Hypercoagulability with thromboembolic events within 6 months (e.g., stroke, DVT, pulmonary embolism).\n16. Pregnancy, lactation.\n17. The investigator concluded that the patient was not suitable to participate in the study (such as not conforming to the most beneficial treatment for the patient, patient compliance, etc.).",{"count":88,"type":20},180,[23,24],"This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.",[92],"HR-positive, HER2-negative Advanced Breast Cancer","RECRUITING","2025-04-22",{"date":96,"type":33},"2025-04-29",{"date":98,"type":33},"2024-01-02",{"date":62,"type":20},{"name":39,"class":40},2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100567736","phase-2-a-study-of-ty-9591-with-chemotherapy-as-1st-line-treatment-in-patients-with-mutated-epidermal-growth-factor-receptor-nsclc-100567736","NCT06672068","A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC","To Evaluate the Efficacy and Safety of TY-9591 Tablets Combined With Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation","Inclusion Criteria:\n\n1. Male or female ≥18 years old and \\\u003C80 years old.\n2. Patients with non-squamous non-small cell lung cancer (NSCLC) diagnosed by histology or cytology as locally advanced (clinical stage IIIB, IIIC, no chance of radical surgery or radical chemoradiotherapy) or metastatic (clinical stage IVA, IVB) (according to the AJCC TNM staging criteria for lung cancer, 8th edition).\n3. Tissue or blood samples tested positive for EGFR sensitive mutations (including exon 19 deletion, exon 21 L858R mutation, alone or in combination with other EGFR mutations) by central laboratory or research center, other tertiary hospitals, or third-party laboratories.\n4. He had received no previous systemic antitumor therapy for locally advanced or metastatic non-small-cell lung cancer. Patients who had received previous adjuvant and neoadjuvant therapy and definitive radiotherapy\u002Fchemoradiotherapy were allowed if the last treatment was more than 12 months after disease recurrence or metastasis.\n5. Patients had at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) : no previous local treatment such as radiotherapy, an accurately measurable target lesion at baseline, and a baseline maximum diameter of 10mm or more (or a short diameter of 15mm or more in the case of a lymph node). For patients with postoperative recurrence, lesions in the area of previous local treatment (radiotherapy or other therapy) were considered measurable only if disease progression occurred more than 6 months after the end of treatment.\n6. With an ECOG score of 0-1 and no deterioration during the first 2 weeks of the study, survival was expected to be no less than 3 months.\n7. Patients were required to have adequate bone marrow reserve and no hepatic, renal, or coagulopathy, with laboratory values that met the following criteria (no previous blood or platelet transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) transfusion within 14 days before the first dose in this study).\n8. Male patients and female patients of reproductive age should take adequate contraceptive measures within 3 months after signing the study informed consent to the last study drug treatment; In women of childbearing age, the blood pregnancy test results were negative within 7 days before the first dose.\n9. Before the first dose of study drug, all toxic effects (except alopecia and grade 2 neurotoxicity related to prior platinum-based chemotherapy) associated with previous systemic therapy (e.g., adjuvant chemotherapy) had been resolved (to grade 1 or less).\n\nExclusion Criteria:\n\n1. The following treatments exist for patients:\n\n   1. Previous treatment with any EGFR-TKI was performed.\n   2. Previous systemic anti-tumor therapy for advanced\u002Fmetastatic non-small cell lung cancer (including chemotherapy, targeted therapy, biological therapy, immunotherapy, etc.), neoadjuvant and adjuvant therapy, definitive radiotherapy\u002Fchemoradiotherapy were eligible according to the inclusion criteria\n   3. Anti-tumor therapy with traditional Chinese medicine with anti-tumor indications was received within 7 days before the first dose of the study drug.\n   4. Prior whole brain radiotherapy (WBRT); Received \\>30% bone marrow or extensive radiation within 28 days before the first dose of study drug; Local radiotherapy or palliative radiotherapy for bone metastases had been administered within 7 days before the first dose of study drug.\n   5. Uncontrolled or poorly controlled pleural effusion and pericardial effusion.\n2. Patients with other malignancies or a history of other malignancies were excluded if they had malignancies that had been treated with curative intent, had no known active disease for more than 5 years before the first dose of study treatment, and had a low potential risk of recurrence; Cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid, carcinoma in situ of the cervix and ductal carcinoma in situ of the breast.\n3. rimary malignant brain tumors or unstable brain metastases. Unstable brain metastases were defined as patients with CNS complications requiring urgent neurosurgical treatment (e.g., surgery); Patients requiring glucocorticoids, mannitol, or diuretics with a dose of more than 5mg dexamethasone equivalent for the control of symptoms of brain metastases within 14 days before the first dose; Patients who received local radiotherapy or gamma knife treatment or other local CNS treatment (e.g., intrathecal chemotherapy) within 14 days before the first study dose; Patients with meningeal metastases were not enrolled.\n4. The patient had symptoms of spinal cord compression caused by the tumor.\n5. Uncontrollable cancer pain; Stable doses of narcotic painkillers were not achieved at enrollment.\n6. Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of the study drug, such as inability to take drugs orally, uncontrollable nausea or vomiting, history of large gastrointestinal resection, Uncured recurrent diarrhea, atrophic gastritis (onset age less than 60 years), uncured gastric diseases requiring long-term use of ppis, Crohn's disease, and ulcerative colitis.\n7. A previous or screening history of interstitial lung disease or interstitial pneumonia (ILD), or drug-induced ILD, or radiation pneumonitis requiring hormonal therapy, or the presence of any evidence of active ILD (e.g., acute onset or progressive pneumonitis\u002Fpulmonary fibrosis at baseline) Or pulmonary symptoms that were considered by the investigator to be ineligible for enrollment or factors that were judged to be at high risk for the development of interstitial lung disease.\n8. Had previously received an allogeneic bone marrow transplant.\n9. Pregnant and lactating women.\n10. Known or suspected allergy to test drug ingredients or their analogues.","80 Years",{"count":111,"type":20},60,[24],"This study was a parallel, randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of TY-9591 combined with platinum-based chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations.",[115],"NSCLC","2024-12-27",{"date":118,"type":33},"2024-12-30",{"date":120,"type":20},"2025-02-20",{"date":122,"type":20},"2028-12-01",{"name":39,"class":40},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100512158","phase-2-ty-9591-in-the-patients-with-egfr-mutations-in-advanced-nsclc-with-brain-metastases-100512158","NCT05948813","TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases","A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases","Inclusion Criteria:\n\n1. Male or female aged ≥18 years and \\\u003C80 years.\n2. Patients diagnosed with NSCLC by histology or cytology, with brain metastases.\n3. Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).\n4. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.\n5. Stable brain metastases that do not require immediate or planned local treatment for it during the study period.\n6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n7. The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.\n8. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.\n9. Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.\n10. Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.\n11. Patients can understand and voluntarily sign the informed consent form.\n12. Patient able to comply with study requirements.\n\nExclusion Criteria:\n\n1. Any of the following treatment:\n\n   1. Previous treatment with EGFR inhibitor;\n   2. Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；\n   3. Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;\n   4. Previous whole brain radiation therapy (WBRT); Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;\n   5. Uncontrollable or poorly controlled pleural, abdominal and pericardial effusion;\n   6. Uncontrollable cancerous pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment;\n   7. Major surgery within 28 days of the first dose of study treatment;\n   8. Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;\n   9. Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;\n   10. Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.\n2. Patients with primary malignant brain tumors and unstable brain metastases.\n3. Patients who have had or have a history of other malignancies within the past 5 years (except cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid gland, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast).\n4. The patient had symptoms of spinal cord compression caused by the tumor.\n5. Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.\n6. Cardiac function and disease are consistent with the following:\n\n   1. Corrected QT interval(QTc)\\> 470 milliseconds from 3 electrocardiograms (ECGs);\n   2. Any clinically important abnormalities in rhythm;\n   3. Any factors that increase the risk of QTc prolongation;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n7. Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.\n8. Previous history of interstitial lung disease(ILD) or drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.\n9. Previous allogeneic bone marrow transplant.\n10. Pregnant or lactating women.\n11. Any other disease or medical condition that is unstable or may affect the safety or study compliance.\n12. Hypersensitivity to TY-9591 or similar compounds or excipients.",{"count":132,"type":20},420,[24],"This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.",[115,136,137],"EGFR Activating Mutation","Brain Metastases","2024-11-18",{"date":140,"type":33},"2024-11-21",{"date":142,"type":33},"2023-08-17",{"date":144,"type":20},"2027-12-30",{"name":39,"class":40},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":154,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":41},"100534995","phase-1-a-study-of-tyk-00540-in-adult-patients-with-solid-tumors-100534995","NCT06246071","A Study of TYK-00540 in Adult Patients With Solid Tumors","A Phase Ia\u002FIb, Multicenter, Open-label Study of TYK-00540, Administered Orally in Adult Patients With Locally Advanced\u002FMetastatic Solid Tumors","ASOTIAPWST","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. In the Single-agent escalation phase, subjects should fulfill the following criterion at Screening: Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumors that do not have, failed or intolerated standard of care (SOC).In the single-agent expansion phase, subjects should fulfill the following criteria at Screening: Cohort 1: Histologically or cytologically confirmed platinum-resistant HGSOC (Platinum-resistant: responds at first to treatment with drugs that contain platinum, but then comes back within 6 months period; only female subjects will be enrolled). Cohort 2: Histologically or cytologically confirmed locally advanced\u002Fmetastatic TNBC who have received two lines of standard of care (SOC) regimens, including:\n\n   1. Any prior treatment can be considered as one of the SOC regimens if executed on patients with the receptor status of triple-negative no matter the previous pathological type;\n   2. For patients whose treatment have been changed due to intolerability to toxicity, the intolerable regimens can be included as one of the prior standards of care regimens;\n   3. For neoadjuvant and\u002For adjuvant chemotherapy, if relapse or disease progression to locally advanced or metastatic disease occurs during treatment or within 12 months after discontinuation of treatment (at least 2 cycles have been completed), it will be considered as one of the SOC regimens;\n   4. For patients with documented germline BRCA1\u002FBRCA2 mutations, if they have been treated with an approved PARP inhibitor, then the PARP inhibitor can be considered as one of the 2 lines of prior SOC regimens required.\n\n   In the combination-agent escalation and combination expansion phase (Cohort 3), subjects should fulfill the following criteria at Screening: ER+\u002FHER2-breast cancer with who have relapsed or progressed after treatment with CDK4\u002F6 inhibitors (no prior treatment of fulvestrant or other SERDs, SERCA; no contraindications to the use of fulvestrant; for locally advanced or metastatic disease stages, the number of chemotherapy lines≤ 1). Note: Histologically-confirmed breast carcinoma expressing positive ER (≥1% tumor cells expressing ER as positive on IHC staining, recommended by ASCO\u002FCAP Guideline Update 2020. For the purposes of the expansion study, only ER+ IHC staining ≥10% will be considered ER+ in this cohort. Negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by the negative ISH, recommended by ASCO\u002FCAP Guideline 2018.\n3. Subjects in the escalation phase should have measurable or evaluable lesions at baseline; Measurable lesions required in the expansion phase (RECIST 1.1).\n4. ECOG performance status is 0 to 1 and there is no deterioration in the 2 weeks prior to the first dose.\n5. Life expectancy of at least 3 months.\n6. Adequate organ functions, defined as: ALT or AST ≤ 2.5×the upper limit of normal (ULN) or ≤ 5 ×ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor) and Total bilirubin ≤ 1.5 ×ULN (subjects with Gilbert's Disease may be enrolled with Sponsor approval); Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL, Platelet count ≥ 80 ×109\u002FL and Hemoglobin (Hb) ≥ 9 mg\u002FdL, not requiring growth factor and transfusion support for at least 14 days prior to screening; Adequate renal function, creatinine clearance ≥ 60 mL\u002Fmin (According to the Cockcroft and Gault formula). Coagulation function: International normalized ratio (INR) ≤ 1.5 ×ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN. Left ventricular ejection fraction (LVEF) ≥50%.\n7. Willing and able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).\n8. Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and 6 months following the last dose of study treatment; this may include barrier methods such as condom or diaphragm with spermicidal gel.\n\nExclusion Criteria:\n\n1. Known allergy to any excipients of TYK-00540 tablets (for combination-agent escalation phase and combination expansion phase, known contraindications to fulvestrant should also be considered).\n2. Subjects with prior therapy of: Systemic anti-tumor treatment such as standard chemotherapy, macromolecular targeted drugs and immunological drug therapy within 28 days prior to the first dose; reception of endocrine therapy, small molecule targeted drugs and oral fluorouracil within 14 days before the first dose; reception of nitrosoureas and mitomycin within 6 weeks prior to the first dose Major surgery (except minor surgeries such as appendicitis and tumor biopsy) within 4 weeks prior to the planned start of TYK-00540. Subjects who have taken proton pump inhibitors (PPIs) within 7 days prior to the first dose of TYK-00540, or require continuation of therapy during the study. Subjects who were receiving and need to continue treatment with medications known to prolong the QTc interval or potentially cause Torsade de pointe ventricular tachycardia during the treatment. Participation in other clinical trials (excluding non-interventional drug clinical trials) within 28 days prior to the first dose; Prior allogeneic bone marrow transplantation.\n3. Subjects with other malignancies or a history of other malignant tumors, except for cured basal cell carcinoma of the skin or squamous cell carcinoma, carcinoma in situ of the cervix, papillary thyroid cancer, carcinoma in situ of the breast duct, or other malignant tumors that have survived for more than 5 years.\n4. Any unresolved toxicities from prior therapy greater than NCI CTCAE Grade 1 at the time of starting study treatment with the exception of Grade 2 alopecia and prior platinum-therapy related neuropathy.\n5. Patients with primary central nervous system (CNS) tumors or CNS metastases that have failed local therapy. Patients who are asymptomatic or clinically stable and do not require steroids and other treatments for CNS metastases ≥ 28 days and are radiographically stable during the screening period may be enrolled.\n6. The subject has symptoms of spinal cord compression due to the tumor.\n7. Uncontrollable or poorly controlled effusion of chest, abdomen, pelvis, or pericardium.\n8. Any baseline 12-lead ECG abnormalities which may impair the safety of subjects (such as baseline QTc interval ≥ 470 msec, complete left bundle branch block (LBBB), acute or unspecified myocardial infarction, active myocardial ischemic ST-T segment changes with clinical significance, second- or third-degree atrioventricular (AV) block, or severe bradycardia or tachycardia).\n9. Have had any of the following in the past 6 months: myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (double-bundle branch block, such as right bundle branch block (RBBB) with left anterior or posterior branch block, third-degree atrioventricular block) , unstable angina, coronary\u002Fperipheral artery bypass grafting, symptomatic chronic heart failure (CHF), Grade III or IV cardiac function as defined by the New York Heart Association, cerebrovascular accident, transient cerebral ischemia, symptomatic pulmonary embolism, and\u002For other clinically significant thromboembolic disease episodes. NCI CTCAE ≥ Grade 2 persistent arrhythmia, any grade of atrial fibrillation (asymptomatic uncomplicated atrial fibrillation was required to be of ≥Grade 2). Enrollment of patients who have an implanted cardiac rhythm device\u002Fpacemaker with QTcF \\> 470 msec needs to be discussed by the investigators and sponsor.\n10. Subjects with any other disease or medical condition that is unstable or could affect their safety or study compliance, any serious or uncontrolled systemic disease, including uncontrolled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Uncontrolled diabetes, active bleeding, ocular lesions, and other serious mental, neurological, cardiovascular or respiratory system diseases.\n11. Known active infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection, except for asymptomatic chronic HBV or HCV carriers. Active HBV, HCV, or HIV infections are defined as:\n\n    1. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥ 2000 cps\u002FmL or 500 IU\u002FmL; HBsAg-negative, anti-HBc-positive patients are at high risk of HBV reactivation who require suppressive antiviral therapy prior to initiation of cancer therapy;\n    2. Anti-HCV antibody positive and HCV-RNA \\> upper normal limit defined by sites;\n    3. Anti-HIV antibody positive with uncontrolled opportunistic infections; anti-HIV antibody positive with CD4+ count\\\u003C 350 cells\u002FuL that requires HIV therapy prior to the cancer treatment; other conditions allowing concurrent ART but the therapy not tolerated and that the toxicities confused with investigational drug toxicities.\n12. History of positively diagnosed interstitial lung disease or interstitial pneumonia (ILD), drug-induced ILD, or radiation pneumonitis requiring hormone therapy, or any evidence of active ILD (e.g., acute onset or progressive pneumonitis\u002Fpulmonary fibrosis at baseline), or the pulmonary symptoms which are not suitable for enrollment in the investigator's judgment or the high-risk factors which may cause interstitial lung disease and are not suitable for enrollment.\n13. Clinically significant gastrointestinal abnormalities at screening that may affect the intake, transport or absorption of drugs (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcer, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, gastric diseases requiring long-term administration of PPIs without a cure, etc.).\n14. Clinically significant hypercoagulability.\n15. Pregnant and lactating women.\n16. Subjects who, in the opinion of the investigator, would not be suitable for participation in this study (e.g., not in line with the treatment of the subject's best benefit, subject compliance, etc.).",true,{"count":156,"type":20},156,[23],"The primary objective of this study is to evaluate the safety and tolerability of TYK-00540, with dose-escalation stage and dose-expansion stage.",[160],"Locally Advanced or Metastatic Solid Tumors","2024-02-06",{"date":163,"type":33},"2024-02-07",{"date":98,"type":33},{"date":166,"type":20},"2026-12-05",{"name":39,"class":40},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":109,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":101},"100468664","phase-3-phase-iii-study-of-ty-9591-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-fleteo-100468664","NCT05382728","Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)","A Phase III, Randomised, Double-blind, Multi-center Study to Assess the Efficacy and Safety of TY-9591 Tablets Versus Osimertinib as First Line Treatment in Patients With EGFR-sensitive Mutation, Locally Advanced or Metastatic Non Small Cell Lung Cancer.","Inclusion Criteria:\n\n1. Male or female aged ≥18 years and \\\u003C80 years.\n2. Locally advanced or metastatic NSCLC diagnosed by histology or cytology.\n3. Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites).\n4. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.\n5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.\n6. The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.\n7. Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.\n8. Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.\n9. Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.\n10. Patients can understand and voluntarily sign the informed consent form.\n11. Patient able to comply with study requirements.\n\nExclusion Criteria:\n\n1. Any of the following treatment:\n\n   1. Previous treatment with EGFR inhibitor;\n   2. Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；\n   3. Previous treatment with standard chemotherapy with 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug;\n   4. Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;\n   5. Uncontrollable or poorly controlled pleural and abdominal effusion;\n   6. Major surgery within 28 days of the first dose of study treatment;\n   7. Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4;\n   8. Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;\n   9. Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.\n2. Pathologically confirmed squamous cell carcinoma or squamous cell component predominance in NSCLC.\n3. Symptomatic brain metastases or leptomeningeal metastases.\n4. Patients have spinal cord compression caused by tumor.\n5. Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.\n6. Cardiac function and disease are consistent with the following:\n\n   1. Corrected QT interval(QTc)≥ 470 milliseconds from 3 times of electrocardiograms (ECGs);\n   2. Any clinically important abnormalities in rhythm;\n   3. Any factors that increase the risk of QTc prolongation;\n   4. Left ventricular ejection fraction (LVEF) \\\u003C50%.\n7. Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.\n8. Previous history of interstitial lung disease(ILD), drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.\n9. Previous allogeneic bone marrow transplant.\n10. Pregnant or lactating women.\n11. Any other disease or medical condition that is unstable or may affect the safety or study compliance.\n12. Hypersensitivity to investigational drug or similar compounds or excipients.",{"count":176,"type":20},680,[178],"PHASE3","To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.",[115,136],"2024-01-28",{"date":183,"type":33},"2024-01-30",{"date":185,"type":33},"2022-06-08",{"date":187,"type":20},"2027-12",{"name":39,"class":40},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":205,"leadSponsor":207,"locationsCount":101},"100505846","phase-1-a-study-of-ty-2699a-in-patients-with-locally-advanced-or-metastatic-solid-tumors-100505846","NCT05866692","A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors","A Phase I, Multicenter, Open-label Study of TY-2699a, Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Be able to provide written informed consent approved by institutional review board (IRB) or independent ethics committee (IEC).\n2. Age ≥18 years.\n3. At the escalation stage, patients should fulfill the following criteria at Screening:\n\n1\\) Participants with locally advanced or metastatic solid tumors including TNBC, ER+HER2-BC, ovarian cancer, small cell lung cancer, castrate-resistant prostate cancer (CRPC), or PDAC with KRAS mutant; Or any other locally advanced or metastatic solid tumor with evidence of deregulated RB-pathway based on available molecular test results and after sponsor review to confirm eligibility as determined with prior molecular assays performed in a CLIA-certified or equivalent laboratory. (Note: ① 0% - 1% of tumor cells expressing ER or PR as negative while ≥ 1% of tumor cells expressing ER or PR as positive on IHC staining, recommended by ASCO\u002FCAP guideline Update 2020; negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by the negative ISH, recommended by ASCO\u002FCAP Guideline 2018; ② Genes of KRAS and other biomarkers will be detected by the Polymerase Chain Reaction (PCR) or Next-Generation Sequencing (NGS)); 2) Patients who have progressed on established standard medical anti-cancer therapies for a given tumor type or have been intolerant to such therapy, or in the opinion of the investigator have been considered ineligible for a particular form of standard therapy on medical grounds.\n\n4\\. At the expansion stage, patients should fulfill the following criteria at Screening :\n\n1)Cohort : TNBC patients progressed on ≥ 2 previous lines of therapy and\u002For other solid tumors will receive TY-2699a. ① Previous therapy can be of any nature (chemotherapy, immunotherapy, antiangiogenics, experimental therapy, etc.); ② Histologically-confirmed breast carcinoma not expressing ER, PR, and HER2 (negative ER and PR is defined as \\\u003C 1% tumor cells expressing ER and PR on IHC staining, recommended by ASCO\u002FCAP Guideline Update 2020; negative HER2 is defined as IHC staining 0 or 1+ , or IHC 2+ but confirmed by the negative ISH, recommended by ASCO\u002FCAP Guideline 2018; negative HER2 is defined as IHC 0 or 1+, or IHC 2+ but confirmed by the negative ISH, recommended by ASCO\u002FCAP Guideline 2018); ③ With or without BRCA mutation.\n\n5\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and life expectancy \\> 3 months.\n\n6\\. Capability to swallow intact capsule (without chewing, crushing or opening). 7. At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumor Version 1.1 (RECIST v1.1, Appendices 15.2 RECIST v1.1 ) determined by the investigator.\n\n8\\. All acute toxic effects (excluding alopecia and neuropathy associated with prior platinum-based drug therapy) of any prior therapy recovered to grade ≤1 based on NCI CTCAE v5.0.\n\n9\\. Baseline laboratory results fulfilling the following requirements: Absolute neutrophils count (ANC) ≥1500\u002Fmm3 (1.5×109\u002FL) \\* Platelets ≥100,000\u002Fmm3 (100×109\u002FL) \\* Hemoglobin \\> 90 g\u002FL\\* Estimated creatinine clearance ≥55 mL\u002Fmin+ Total serum bilirubin \\\u003C1.5 × ULN \\\u003C3.0 × ULN if known Gilbert's disease Liver transaminases (AST\u002FALT) \\\u003C2.5 × ULN; \\\u003C5 × ULN if liver metastases are present ULN: upper limit normal.\n\n* No blood transfusion, blood products, or hematopoietic factors such as G-CSF, erythropoietin or albumin within 14 days prior to first dose.\n\n  * Cockcroft-Gault Equation. 10. For female patients of childbearing potential, the serum or urine pregnancy test within 7 days prior to the start of TY-2699a treatment should be negative.\n\n    11\\. Male and female patients of childbearing potential must agree to use at least two method of highly effective contraception from signing ICF, throughout the study and continued for 90 days after the last dose of TY-2699a treatment at the escalation stage or for the labeled duration of contraception of the combined approved drug fulvestrant (e.g., FASLODEX requires one-year contraception after the last dose) or PD-L1 antibody (will decide a brand approved in US before starting expansion stage) after the last dose at the expansion stage.\n\n    12\\. Willing and able to comply with all aspects of the protocol.\n\nExclusion Criteria:\n\n1. Concurrent participation in another interventional clinical trial, unless the patient at long-term follow-up period.\n2. Patients with the following treatment:\n\n   1. Received undergone major surgery (except minor surgery such as appendicitis, tumor biopsy, etc.) within 4 weeks prior to the first dose.\n   2. Received bone marrow (equal to area of pelvis) or extensive radiation therapy within 28 days prior to the first dose; received local radiation therapy (e.g., thoracic spine and rib radiation therapy) within 7 days prior to the first dose of the study drug.\n   3. Received CYP3A and CYP2C8 strong inducers\u002Fstrong inhibitors or p-gp glycoprotein inhibitors within 14 days prior to the first dose (see Appendices 15.3 Examples of CYP450-related Drugs\u002Ffood).\n   4. History of proton pump inhibitors (PPIs) within 4 days prior to the first dose of TY-2699a; OR history of histamine H2 blockers within 2 days prior to the first dose of TY-2699a. Patients who are receiving and require continuation of drug therapy during the study with drugs known to prolong the QTc interval or that may cause torsades de pointes.\n   5. Prior exposure to transcriptional kinase family CDK inhibitors, such as the CDK7 and CDK9 inhibitors SY-5609，CT-7001，Alvocidib，Dinaciclib，Seliciclib and SY-1365. Exception: Previous exposure to cell cycle CDK inhibitors such as inhibitors of CDK4 and CDK6 (ie, palbociclib) is allowed.\n3. History of other previous cancer (except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected), requiring therapy within the previous 5 years\n4. Patients with unstable brain metastases: Patients with CNS complications requiring urgent neurosurgical treatment (e.g., surgery, etc.) (except when surgery is completed \\>7 days and side effects from complications are ≤ grade 1); patients requiring glucocorticoids, mannitol or diuretics at equivalent doses greater than 4 mg of dexamethasone to control symptoms of brain metastases within 14 days prior to the first study dose; patients who have undergone whole brain radiation therapy or gamma knife within 14 days prior to the first study dose; patients with symptoms of spinal cord compression from the tumor. Note: conversely, patients with stable CNS metastasis and those who are beyond the treatment washout period of 14 days per protocol are eligible to the study.\n5. Epilepsy needing treatment; having a history of psychotropic substance abuse that cannot abstain; have mental disorders (successful abstain must pass at least 2 weeks without observing withdrawal reaction).\n6. Patients receiving long-term systemic immunosuppressant therapy (≤10 mg\u002F day of prednisone or other equivalent dose of corticosteroid inhalation or topical administration can be included).\n7. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (electrocardiogram interval measured from the onset of the QRS complex to the end of the T wave) for heart rate QTc \\> 470 msec obtained from 3 electrocardiograms, using the screening clinic electrocardiogram machine derived QTc value.\n   2. Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \\>250 msec). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval during Screening.\n   3. Left ventricular ejection fraction (LVEF) \\\u003C50%；\n   4. Clinically significant cardiovascular disease (either active at Screening or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥II), cerebrovascular accident or transient ischemic attack, stroke, symptomatic bradycardia, or requirement for anti-arrhythmic medication.\n   5. Unstable patients that may affect their safety or compliance of study, any serious or uncontrolled systemic disease including uncontrolled high blood pressure (systolic blood pressure \\>160mmHg, or diastolic pressure \\>100mmHg), uncontrolled diabetes (fasting plasma glucose \\>10 mmol\u002FL), active bleeding, severe eye disease, severe psychosis, nerve, vascular, or respiratory disease.\n8. Known active infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection, except for asymptomatic chronic HBV or HCV carriers. Active HBV, HCV, or HIV infections are defined as\n\n   1. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥ 2000 cps\u002FmL or 500 IU\u002FmL; HBsAg-negative, anti-HBc-positive patients are at high risk of HBV reactivation who require suppressive antiviral therapy prior to initiation of cancer therapy\n   2. Anti-HCV antibody positive and HCV-RNA \\> upper normal limit defined by sites\n   3. Anti-HIV antibody positive with uncontrolled opportunistic infections; anti-HIV antibody positive with CD4+ count \\\u003C 350 cells\u002FuL that requires HIV therapy prior to the cancer treatment; other conditions allowing concurrent ART but the therapy not tolerated and that the toxicities confused with investigational drug toxicities. Note: Examples of drug-drug interactions that affect absorption, distribution, metabolism, and excretion of the TY-2699a are shown in Appendices 15.3 Examples of CYP450-related Drugs\u002Ffood.\n9. Diagnosed interstitial lung disease with or without symptoms, as well as conditions that may cause pulmonary toxicity or related pneumonia after using TY-2699a, or pulmonary symptoms deemed by the investigator to have high risk of developing interstitial lung disease. Note: Patients with history of prior radiation pneumonitis will not be excluded.\n10. Active gastrointestinal disease with significant symptoms (e.g., gastric ulcer, Crohn's disease, ulcerative colitis, short gut syndrome) or other malabsorption syndromes that will impact in ingesting, transporting, or absorbing the drug.\n11. Known\u002Fsuspected allergy to the composition of TY-2699a or the analogues.\n12. Pregnant and breastfeeding women.\n13. The Prinicpal Investigator considers that the patient is not suitable to participate in this study.",{"count":156,"type":20},[23],"This is a phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.",[200],"Solid Tumor, Adult","2023-11-03",{"date":203,"type":33},"2023-11-07",{"date":142,"type":33},{"date":206,"type":20},"2026-10",{"name":39,"class":40},""]