[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TransThera Sciences (Nanjing), Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,66,91,107],{"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},"100631269","phase-2-efficacy-and-safety-of-tinengotinib-tablets-combined-with-fulvestrant-injection-in-patients-with-hr-positive-and-her-2-negative-recurrent-or-metastatic-breast-cancer-who-have-failed-prior-treatment-100631269",false,"NCT07498478","Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment","A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed breast cancer with evidence of local recurrence or distant metastasis and no indication for surgery or radiotherapy;\n2. Breast cancer confirmed as HR+\u002FHER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample (from either the primary or metastatic site, excluding bone lesions). HR-positive, HER2-negative or low expression as defined in this study refer to the Chinese Society of Clinical Oncology \\[CSCO\\] 2024 criteria;\n3. Participants must meet at least one of the following criteria: a) prior bilateral oophorectomy, or age ≥60 years; b) age \\\u003C60 years, with natural amenorrhea (in the absence of medication or pathological conditions) for ≥12 months, and estradiol and FSH levels within the postmenopausal range; c) age \\\u003C60 years, currently undergoing ovarian suppression therapy (e.g., LHRH agonist) and requiring continued treatment during the study, with estradiol and FSH levels maintained within the postmenopausal range;\n4. Participants who have previously failed 1-2 lines of endocrine therapy (including AI, SERD, and SERM) for recurrent or metastatic disease are eligible. Subjects with initial diagnosis showing weak ER positivity by IHC (tumor cells with nuclear staining accounting for 1%-10%) are not eligible for enrollment;\n5. Participants must have experienced disease progression after prior treatment with at least one CDK4\u002F6 inhibitor (CDK4\u002F6i), including in the neoadjuvant, adjuvant, or systemic treatment settings;\n6. Participants who have previously failed 0-2 lines of systemic chemotherapy (cytotoxic drugs) for recurrent or metastatic disease. Antibody-drug conjugates (ADCs) are not counted as systemic chemotherapy;\n7. ECOG ≤ 1;\n8. Participants must meet at least one of the following criteria (per RECIST v1.1): a) At least one measurable lesion as defined by RECIST v1.1 at baseline; if the only target lesion is a non-nodal lesion, its longest diameter must be ≥15 mm; b) When bone lesions are the only measurable lesions, lytic or mixed bone lesions may be selected as target lesions; subjects with only blastic bone lesions are not eligible for enrollment.\n9. Adequate organ and bone marrow function;\n10. Premenopausal participants receiving ovarian suppression therapy must agree to use adequate contraception to avoid pregnancy during the study and for at least 3 months after the end of treatment;\n11. Able to sign informed consent and comply with the protocol.\n\nExclusion Criteria:\n\n1. Participants who are pregnant or breastfeeding;\n2. Conditions judged by the investigator as making the participant unsuitable for study drug treatment, including but not limited to: a history of severe allergy to the components or excipients of the study drug, prior treatment history with the study drug, or presence of complications that may be life-threatening in the short term (such as pleural, pericardial, or abdominopelvic effusions that cannot be controlled by drainage or other methods);\n3. Uncontrolled hypertension (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg), allowing for the lowest value from up to two repeat measurements;\n4. Participants with brain or central nervous system (CNS) metastases that have progressed as confirmed by imaging or clinically within 28 days before the start of treatment (e.g., evidence of new or enlarging brain metastases on imaging, new neurological symptoms attributable to brain\u002FCNS metastases);\n5. Participants with concurrent other malignancies or hematologic malignancies that are progressing or require active treatment (excluding basal cell carcinoma of the skin, other non-invasive or indolent malignancies, or cured tumors); Hormone replacement therapy is permitted (e.g., thyroxine replacement therapy post-thyroidectomy);\n6. Participants who have received systemic treatment with corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive medications within 14 days prior to the initiation of the study drug;\n7. Participants who have received other systemic anti-tumor therapies or treatment with investigational drugs prior to the initiation of the study drug, with a washout period of approximately 5 half-lives or 14 days, whichever is shorter;\n8. Participants who have received extensive radiotherapy or major surgery within 4 weeks prior to the initiation of the study drug, or local palliative radiotherapy within 2 weeks. (If the investigator judges that this does not pose an additional safety risk, initiation of the study drug during the washout period may be permitted with sponsor agreement.)\n9. Participants who have not yet recovered from adverse events resulting from prior anti-tumor therapy (excluding adverse events ≤ Grade 1 per CTCAE, or ≤ Grade 2 adverse events that the investigator judges do not pose a safety risk).\n10. History of severe cardiac or cerebrovascular disease;\n11. Participants who have severe gastrointestinal disease or gastrointestinal dysfunction that may lead to absorption, metabolism or excretion of the study drug, enrollment eligibility will be based on the investigator's judgment (including but not limited to total gastrotomy, short bowel syndrome).\n12. Participants who have bleeding disorders or thrombotic disorders or therapeutic anticoagulant therapy requiring INR monitoring.\n13. Participants who have received a strong CYP3A inhibitor and inducer before starting the study drug, within an interval of ≤ 2 weeks or 5 half-lives (whichever is shorter);\n14. Tested positive for the human immunodeficiency virus (HIV);\n15. Participants with active HBV infection and\u002For HCV infection;\n16. Participants who are unable to swallow or tolerate oral medication.\n17. The investigator determines that there are other reasons making the participant unsuitable for participation in the study.","FEMALE","18 Years",{"count":19,"type":20},94,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are:\n\n1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?\n2. What medical problems do participants have when taking the combination therapy?\n\nParticipants will:\n\nTake tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A.\n\nIn Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.",[26],"Breast Cancer","RECRUITING","2026-03-25",{"date":30,"type":31},"2026-03-27","ACTUAL",{"date":33,"type":31},"2026-03-17",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"TransThera Sciences (Nanjing), Inc.","INDUSTRY",13,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100618230","phase-3-efficacy-and-safety-of-tt-00420-tinengotinib-tablets-versus-chemotherapy-in-patients-with-advanced-intrahepatic-cholangiocarcinoma-harboring-fgfr2-fusionsrearrangements-or-mutations-100618230","NCT07328919","Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions\u002FRearrangements or Mutations","A Phase III, Randomized Controlled, Open-Label, Multicenter Clinical Study Evaluating the Efficacy and Safety of TT-00420 Tablets Versus Chemotherapy in Patients With Surgically Unresectable Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions\u002FRearrangements or Mutations, Who Have Progressed or Relapsed After Prior First-Line Systemic Therapy","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed intrahepatic cholangiocarcinoma.\n3. Subjects diagnosed with stage III or IV intrahepatic cholangiocarcinoma according to the American Joint Committee on Cancer (AJCC) 8th Edition (2018) staging system, and assessed by the investigator as not eligible for curative surgical resection.\n4. Subjects who have experienced recurrence or progression after receiving only one prior line of systemic chemotherapy combined with immunotherapy (PD-1\u002FPD-L1 inhibitor), with or without targeted therapy. Sequential immunotherapy following the completion of chemotherapy cycles is also considered part of the first-line combined regimen. First-line systemic chemotherapy is defined as gemcitabine\u002Fcapecitabine with or without a platinum-based agent.\n\n   Note: Recurrence within 6 months after completion of adjuvant or neoadjuvant therapy will be considered as a line of systemic therapy. Local treatments do not count as systemic therapy.\n5. The presence of FGFR2 gene fusion\u002Frearrangement or mutation must be confirmed by detection using tumor tissue samples provided by the patient and analyzed by a central laboratory.\n6. At least one radiographically measurable lesion must be present according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. ECOG ≤ 1.\n8. Subjects must have adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Subjects with a history of prior treatment with TT-00420 tablets.\n2. Subjects with a known severe allergic reaction to any agent in the study and for whom no alternative study treatment is available.\n3. Subjects receiving corticosteroid therapy for CNS metastases are also ineligible.\n4. Concurrent active malignancy requiring active treatment. Malignancies diagnosed \\>5 years ago without the need for treatment, as well as cured localized tumors such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, or papillary thyroid carcinoma, are allowed.\n5. Administration of other anti-tumor drugs prior to randomization with an interval of ≤ 5 half-lives or 14 days (whichever is shorter), or failure to recover from adverse events of prior therapies (except for adverse events of ≤ Grade 1, or ≤ Grade 2 events judged by the investigator as not constituting a safety risk).\n6. Prior radiation therapy (large-field radiotherapy within 4 weeks, or local palliative radiotherapy within 2 weeks, before randomization), or failure to recover from related adverse events, is excluded. However, initiation of the investigational drug during the washout period is permitted with sponsor approval, if the investigator believes it is in the subject's best interest based on a favorable benefit-risk assessment.\n7. Subjects who have undergone major surgery within 4 weeks prior to randomization, or who have not recovered from related adverse events (with the exception of ≤ Grade 1 events or non-risk Grade 2 events per investigator's judgment), are excluded.\n8. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and\u002For ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening).","ALL",{"count":49,"type":20},138,[51],"PHASE3","This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions\u002Frearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.",[54,55],"Intrahepatic Cholangiocarcinoma (Icc)","Advanced Cholangiocarcinoma","NOT_YET_RECRUITING","2025-12-26",{"date":59,"type":31},"2026-01-09",{"date":61,"type":20},"2026-01",{"date":63,"type":20},"2030-12-31",{"name":37,"class":38},20,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100512132","phase-3-study-of-tinengotinib-vs-physicians-choice-a-treatment-of-subjects-with-fgfr-altered-in-cholangiocarcinoma-100512132","NCT05948475","Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma","A Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib VS Physician's Choice in Subjects With FGFR-altered, Chemotherapy- and FGFR Inhibitor-Cholangiocarcinoma","FIRST-308","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Histologically or cytologically confirmed CCA\u002Fadenocarcinoma of biliary origin with radiological evidence of unresectable or metastatic disease.\n3. Documentation of FGFR2 fusion\u002Frearrangement gene status\n4. Subjects must have received at least one line of prior chemotherapy and exactly one FDA approved FGFR inhibitor.\n\nExclusion Criteria:\n\n1. Prior receipt of two or more FGFR inhibitors, either approved or investigational drugs.\n2. Subjects with known brain or central nervous system (CNS) metastases that have radiologically or clinically progressed in the 28 days prior to initiation of therapy. Subjects with asymptomatic brain\u002FCNS metastases or treated brain\u002FCNS metastases that have been clinically stable for 14 days on steroids without escalation of steroids are eligible for enrollment.\n3. Subjects with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, including those that have previously undergone potentially curative therapy.\n4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5 half-lives or 14 days, whichever is shorter, prior to starting the study drug or who have not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2 alopecia, fatigue\u002Fasthenia, and neuropathy due to trauma) from adverse events (AEs) of prior therapy.\n5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormone therapy may be allowed with Sponsor approval.\n6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting the study drug or who have not recovered from AEs of prior therapy.\n7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hg systolic and\u002For ≥ 90 mm Hg diastolic despite adequate treatment with antihypertensive medications at screening)",{"count":75,"type":20},200,[51],"This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory\u002FRelapsed Cholangiocarcinoma",[79],"Cholangiocarcinoma",[81],"Refractory\u002FRelapsed Cholangiocarcinoma","2024-06-21",{"date":84,"type":31},"2024-06-24",{"date":86,"type":31},"2023-12-20",{"date":88,"type":20},"2026-08",{"name":37,"class":38},87,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":47,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":106,"locationsCount":5},"100544525","rollover-study-to-provide-continued-access-to-tt-00420-tinengotinib-for-subjects-with-advanced-solid-tumors-100544525","NCT06370013","Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors","An Open Label, Multicenter Rollover Study for Continued Characterization of Safety and Tolerability of TT-00420 (Tinengotinib) Tablet Monotherapy in Adult Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subject is currently enrolled in a pre-defined TransThera-sponsored parent study and is receiving tinengotinib as a single agent.\n2. Subject is currently deriving clinical benefit from the study treatment, as determined by the investigator.\n\nExclusion Criteria:\n\n1. Subject has been permanently discontinued from tinengotinib in the parent protocol for any reason other than enrollment in the Rollover study\n2. Subject does not meet the criteria specified in the parent protocol for continued treatment on study.","EXPANDED_ACCESS","This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors",[101,79],"Advanced Solid Tumors","AVAILABLE","2024-04-16",{"date":105,"type":31},"2024-04-17",{"name":37,"class":38},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100491790","phase-1-a-phase-1-study-to-evaluate-the-safety-and-tolerability-of-tt-01488-in-patients-with-b-cell-malignancies-100491790","NCT05683717","A Phase 1 Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies","A Phase I, Multicenter, Open Label, and Dose-Escalation Study of TT-01488, Administered Orally in Adult Patients With B-Cell Malignancies","Inclusion Criteria:\n\n* Participants with histologically confirmed B-cell malignancy, failed or intolerant to either ≥ 2 prior standard\u002Fcommon regimens given in combination or sequentially OR have received 1 prior BTK-containing regimen, relapse\u002Frefractory, and with treatment indication:\n\n  * CLL\u002FSLL treated with prior immunochemistry or BTK inhibitor containing regimen;\n  * DLBCL treated with prior CD20 or anthracyclines containing regimen;\n  * Other types of B-cell NHL treated with prior CD20 containing regimen\n* Adequate organ function, defined by the following laboratory parameters:\n\n  * Hematologic:\n* Absolute neutrophil count (ANC) ≥ 0.75×10\\^9\u002FL, and ≥ 0.5×10\\^9\u002FL if bone marrow involved\n* Platelets ≥ 50×10\\^9\u002FL without transfusion within 7 days, and ≥ 30×10\\^9\u002FL if bone marrow involved\n* Hemoglobin ≥ 8.0 g\u002FdL without transfusion within 7 days, and ≥ 7.0 g\u002FdL if bone marrow involved\n\n  * Coagulation:\n* Prothrombin time (PT) ≤ 1.5 × ULN\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n\n  * Renal function:\n* Creatinine clearance ≥ 30 mL\u002Fmin estimated glomerular filtration rate based on Cockcroft-Gault formula\n\n  * Liver function:\n* Total bilirubin ≤ 1.5 × ULN (unless due to Gilbert's disease)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN unless disease-related\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years or which will not limit survival to \\\u003C 2 years (Note: these cases must be discussed with the Medical Monitor and\u002For Investigator)\n* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or significant screening ECG abnormalities\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 60 days or with any of the following:\n\n  * Active graft versus host disease (GvHD);\n  * Cytopenias from incomplete blood cell count recovery post-transplant;\n  * Need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy;\n  * Ongoing immunosuppressive therapy\n* Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy, including radiation",{"count":115,"type":20},37,[117],"PHASE1","This is a multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.",[120],"B-Cell Malignancies","2023-11-20",{"date":123,"type":31},"2023-11-21",{"date":125,"type":31},"2023-03-30",{"date":127,"type":20},"2028-10-30",{"name":37,"class":38},1,""]