[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignant-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignant-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,60,82],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100630047","phase-1-clinical-trial-of-tqb3205-capsule-in-subjects-with-advanced-malignant-tumors-100630047",false,"NCT07482592","Clinical Trial of TQB3205 Capsule in Subjects With Advanced Malignant Tumors","Phase I Clinical Trial to Evaluate the Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3205 Capsule in Subjects With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Subjects voluntarily joined the study, signed informed consent form, and with good compliance.\n* ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-1; at least 3 months expected survival period.\n* At least 1 measurable lesion for efficacy evaluation.\n* The function of main organs is normal.\n* Women of childbearing age should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; Men should agree to use effective contraceptive measures during the study period and within 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Individuals who have undergone major surgical treatment, significant traumatic injury, or major surgery during the expected study treatment period within 4 weeks prior to the first medication (excluding surgeries specified in the protocol), or have long-term untreated wounds or fractures. (Major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition);\n* Subjects who experience any bleeding or bleeding events ≥ CTC AE grade 3 within 4 weeks prior to the first administration.\n* Active syphilis infected individuals in need of treatment\n* Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;\n* Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation;\n* History of hepatic encephalopathy;\n* Active or uncontrolled infections (≥ CTC AE level 2 infection);\n* Patients with renal failure requiring hemodialysis or peritoneal dialysis;\n* History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases;\n* Individuals with epilepsy who require treatment;\n* Poor control of diabetes (assessed by the investigator);\n* Known to be allergic to research drugs or excipients;\n* Those who have participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first medication;\n* According to the researcher's judgment, there is a situation that seriously endangers the safety of the subjects or affects their ability to complete the study.","ALL","18 Years",{"count":19,"type":20},156,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3205 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3205 capsules.",[26],"Advanced Malignant Cancer","RECRUITING","2026-04-17",{"date":30,"type":31},"2026-04-20","ACTUAL",{"date":33,"type":31},"2026-04-15",{"date":35,"type":20},"2028-12",{"name":37,"class":38},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":58,"locationsCount":59},"100588613","phase-1-a-clinical-trial-on-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-tqb3019-capsule-in-subjects-with-advanced-malignant-tumors-100588613","NCT06943677","A Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsule in Subjects With Advanced Malignant Tumors","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsules in Subjects With Advanced Malignant Tumors","Inclusion Criteria:\n\n* Subjects voluntarily joined the study, signed informed consent form, and with good compliance.\n* ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.\n* Clearly diagnosed recurrent \u002F refractory hematological tumors that meet the World Health Organization (WHO) definition;\n* At least 1 measurable lesion for efficacy evaluation.\n* The function of main organs is normal.\n* Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.\n\nExclusion Criteria:\n\n* Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors \\[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\\].\n* Subjects with central nervous system aggression (CNS);\n* Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;\n* Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);\n* Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;\n* Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.\n* The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);\n* Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;\n* Subjects had an arteriovenous thrombosis event within 6 months.\n* Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;\n* Subjects with any severe and\u002For uncontrolled disease.\n* Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;\n* Previously received treatment with drugs similar to TQB3019 capsules;\n* Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment)\n* Study treatment related: subjects received live or messenger RNA (mRNA) vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;\n* Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;\n* According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.",{"count":48,"type":20},80,[23],"The trial was divided into two phases: dose escalation and dose expansion. The dosing regimens were single-dose study and continuous dosing study. A single-center, open, non-randomized, single-arm clinical trial design was adopted. Subjects with advanced malignant tumors were selected to take TQB3019 capsules orally to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TQB3019 capsules.",[26],"2026-02-10",{"date":54,"type":31},"2026-02-12",{"date":56,"type":31},"2025-05-26",{"date":35,"type":20},{"name":37,"class":38},15,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":39},"100548047","phase-1-a-clinical-trial-of-tqb3117-tablets-in-patients-with-advanced-malignant-cancer-100548047","NCT06415903","A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant Cancer","A Phase I Study to Evaluate the Safety and Tolerance of TQB3117 Tablets in Patients With Advanced Malignant Cancer","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;\n* Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* Has at least one assessable lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria;\n* The main organs function well;\n* Female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* There were other malignant tumors in 3 years;\n* Has multiple factors affecting oral medication;\n* Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;\n* Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;\n* Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;\n* Have a history of psychotropic drug abuse and can not quit or have mental disorders;\n* Subjects with any severe and \u002F or uncontrolled disease included: active hepatitis, have a history of immunodeficiency;\n* Has known symptomatic central nervous system metastases and\u002For cancerous meningitis;\n* Thoracic\u002Fabdominal\u002Fpericardial effusion with clinical symptoms or requiring repeated drainage, or drainage for the purpose of receiving treatment within one month after receiving the investigational drug for the first time;\n* Has participated in other clinical trials within 4 weeks before first dose;\n* According to the judgement of the investigators, there are other factors that may lead to the termination of the study.","75 Years",{"count":69,"type":20},59,[23],"The study is divided into two phases: dose escalation and dose extension. The dosing regimens include a single-dose study and a multiple-dose study. It adopts a single-center, open-label, non-randomized, single-arm clinical trial design, where patients with advanced malignant cancer are selected to orally take TQB3117 tablets. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TQB3117 tablets in patients.",[26],"NOT_YET_RECRUITING","2024-05-14",{"date":76,"type":31},"2024-05-16",{"date":78,"type":20},"2024-06",{"date":80,"type":20},"2026-08",{"name":37,"class":38},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100526167","phase-1-phase-i-study-of-shr-2022-injection-in-the-treatment-of-patients-with-advanced-malignant-tumors-100526167","NCT06131216","Phase I Study of SHR-2022 Injection in the Treatment of Patients With Advanced Malignant Tumors","Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-2022 Injection Alone or in Combination With Other Anti-tumor Treatments in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Voluntary participation in this study, signed informed consent, compliance is good, can cooperate with follow-up\n2. Age 18-80 years old (including both ends), both male and female\n3. Subjects with advanced or metastatic malignant tumors confirmed by pathological tissue or cytology, and who have failed previous standard treatments, are intolerant to standard treatments, or have no standard treatments\n4. Have measurable lesions\n5. ECOG PS score: 0-1\n6. Have a life expectancy of at least 3 months\n7. The functional level of the major organs must meet the requirements\n8. Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating\n\nExclusion Criteria:\n\n1. Central nervous system metastasis or meningeal metastasis with clinical symptoms\n2. Spinal cord compression that has not been treated radically by surgery and\u002For radiotherapy\n3. Patients with uncontrolled tumor-related pain as judged by the investigator\n4. A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator\n5. Systemic antitumor therapy was administered within 28 days prior to treatment in the first study\n6. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period\n7. Received within 28 days prior to the first investigational dose Non-radical chest radiation therapy of 30Gy received within 24 weeks prior to initial dosing. Patients receiving 30Gy of chest radiation therapy, and those receiving palliative radiation ≤30Gy within 14 days prior to the first dose\n8. The AE caused by previous anti-tumor therapy did not recover to CTCAE v5.0 grade evaluation ≤1\n9. Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment\n10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study\n11. Accompanied by interstitial pneumonia or interstitial lung disease\n12. Patients with a history of autoimmune disease\n13. The first study studied patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before medication\n14. The first study was conducted in subjects with severe cardiovascular and cerebrovascular disease within 6 months prior to medication\n15. Arterial\u002Fvenous thrombosis events occurred within 3 months prior to initial administration\n16. The first study studied any other malignancy within 5 years prior to medication\n17. A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients\n18. Have a history of immune deficiency or organ transplantation, and have active hepatitis B or C\n19. Severe infection within 4 weeks prior to the first dose\n20. Patients with active pulmonary tuberculosis within 1 year prior to enrollment were found by history or CT examination\n21. The presence of other serious physical or mental illness, known alcohol or drug dependence, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study","80 Years",{"count":91,"type":20},116,[23],"To evaluate the safety and tolerability of SHR-2022 in patients with advanced malignancies and to determine MTD or MAD versus RP2D",[26],"2023-11-08",{"date":97,"type":31},"2023-11-14",{"date":99,"type":20},"2023-12",{"date":101,"type":20},"2026-12",{"name":103,"class":38},"Suzhou Suncadia Biopharmaceuticals Co., Ltd."]