[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-urothelial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-urothelial-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,39,69,95,121,143,165,187,209,233,253,282,301],{"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":4},"100607237","phase-2-zanzalintinib-for-advanced-urothelial-carcinoma-progressing-after-prior-therapy-100607237",false,"NCT07185945","Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy","Phase II Trial of Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 within 28 days prior to registration.\n4. Histologically confirmed predominant urothelial carcinoma (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1). American Joint Committee on Cancer (AJCC) v8 staging manual. NOTE: must be locally advanced unresectable or metastatic.\n5. Measurable disease according to RECIST 1.1 within 28 days prior to registration.\n6. Progressive disease by RECIST 1.1 following 1 to 3 lines of prior therapy. NOTE: prior lines of therapy must include Enfortumab Vedotin (EV) \\[unless ineligible for EV\\] and PD(L)1 inhibitor \\[unless ineligible for PD(L)1 inhibitor\\]. Prior platinum-based chemotherapy and other agents are allowed but not required.\n7. Prior cancer treatment must be completed ≥ 28 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen to Grade ≤ 1 or baseline. NOTE: Alopecia and sensory neuropathy of Grade ≤ 2 are acceptable.\n8. Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 14 days prior to registration.\n\n   * Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3\n   * Platelets (Plt) ≥ 100,000\u002Fmm3 (without transfusion within 14 days of screening laboratory sample collection)\n   * Hemoglobin (Hgb) ≥ 8 g\u002FdL (without transfusion within 14 days of screening laboratory sample collection)\n   * Calculated creatinine clearance1 ≥ 40 mL\u002Fmin\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3.0 × ULN for patients with Gilbert's disease\n   * Aspartate aminotransferase (AST) ≤ 3 × ULN or ≤ 5 x ULN with liver metastases\n   * Alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 x ULN with liver metastases\n   * Alkaline Phosphatase (ALP) \\\u003C 3 x ULN. NOTE: for patients with bone metastases ALP \\\u003C 5x ULN\n   * International Normalized Ratio (INR) or Prothrombin Time (PT)\n   * Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN\n   * Urine protein to creatinine ratio (UPCR) ≤ 2 mg\u002Fmg (≤ 226.4 mg\u002Fmmol) creatinine\n9. Females of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to registration. If a urine test is done and it is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n10. Females of childbearing potential who are sexually active with a male able to father a child must be willing to abstain from penile-vaginal intercourse or must use an effective method(s) of contraception. Males able to father a child who are sexually active with a female of childbearing potential must be willing to abstain from penile-vaginal intercourse or use an effective method(s) of contraception.\n11. Subjects with known HIV-infection or acquired immunodeficiency syndrome (AIDS)-related illness on stable anti-retroviral therapy with a CD4+ T cell count ≥ 200\u002FµL and undetectable viral load are eligible for this trial. NOTE: To be eligible, participants taking CYP inhibitors (eg, zidovudine, ritonavir, cobicistat, didanosine) or CYP3 inducers (efavirenz) must change to a different regimen not including these drugs 7 days prior to registration. Anti-retroviral therapies (ART) must have been received for at least 28 days prior to registration.\n12. Subjects with a known chronic hepatitis B virus (HBV) infection, must have an undetectable HBV viral load on suppressive therapy, if indicated. Subjects with a history of hepatitis C virus (HCV) infection must have been treated and cured. For subjects with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial.\n13. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. More than 3 lines of prior therapy (prior cisplatin-based perioperative chemotherapy within 1 year prior to subsequent therapy or registration, whichever comes first) and\u002For prior perioperative PD1 inhibitor within 12 weeks prior to subsequent therapy (or registration, whichever comes first) is considered a line of therapy).\n2. Prior receipt of a VEGF inhibitor.\n3. Prior receipt of zanzalintinib.\n4. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 28 days before registration.\n5. Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational therapy) within 28 days prior to Cycle 1 Day 1.\n6. Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin inhibitors ) and platelet inhibitors (eg, clopidogrel) are allowed only if:\n\n   * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n   * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 7 days before registration without clinically significant hemorrhagic complications from the anticoagulation regimen.\n\n   NOTE: Subjects must have discontinued oral anticoagulants within 3 days or 5 half-lives prior to registration, whichever is longer.\n7. Administration of a live, attenuated vaccine within 30 days before Cycle 1 Day 1.\n8. Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 14 days before registration.\n9. Pharmacologically uncompensated, symptomatic hypothyroidism\n10. Current symptomatic central nervous system (CNS) metastases. NOTE: Patients with previously diagnosed CNS metastases are eligible if they have completed treatment and recovered from the acute effects of radiation therapy or surgery prior to registration, have tapered corticosteroid treatment to 10 mg\u002Fday or less and are neurologically stable.\n11. Deep vein thrombosis or pulmonary embolism or prior clinically significant venous events per investigator discretion within 12 weeks prior to registration. NOTE: Subjects with a diagnosis of deep vein thrombosis (DVT) beyond 1 month earlier are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 7 days prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen. Subjects with a diagnosis of DVT within 24 weeks are allowed if asymptomatic and stable at screening and are on a stable dose of the anticoagulant for at least 7 days prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen.\n12. Unstable or deteriorating cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class 3 or 4, class 2 or higher, unstable angina pectoris, new-onset angina, serious cardiac arrhythmias (eg, ventricular flutter, ventricular fibrillation, Torsades de pointes).\n    * Uncontrolled hypertension, defined as Systolic Blood Pressure \\> 140 mm Hg or Diastolic Blood Pressure \\> 90 mm Hg).\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction, or other clinically significant arterial thrombotic and\u002For ischemic event within 24 weeks before registration.\n13. Left ventricular ejection fraction (LVEF) \\\u003C 50% by Echocardiogram or Multigated Acquisition Scan (MUGA). NOTE: Results from an Echocardiogram or MUGA obtained within 1 year prior to registration may be used for eligibility.\n14. Corrected QTcF by Frederica formula \\> 480 ms within 14 days of registration.\n15. Prior history of myocarditis.\n16. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n\n    * Tumors invading the GI-tract from external viscera\n    * Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis\n    * Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 24 weeks prior to registration unless the cause of obstruction is definitively managed and subject is asymptomatic\n    * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 24 weeks before registration. NOTE: Complete healing of an intra-abdominal abscess must be confirmed before Cycle 1 Day 1.\n    * Known gastric or esophageal varices.\n    * Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 28 days prior to registration.\n17. Clinically significant hematuria, hematemesis, or hemoptysis of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before registration.\n18. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed).\n19. Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. NOTE: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior V. cava) may be eligible following sponsor-investigator approval.\n20. Active infection requiring systemic therapy. NOTE: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n21. Inability to swallow tablets or ingest a suspension orally or by nasogastric (NG) or gastrostomy (PEG) tube.\n22. Malabsorption syndrome.\n23. Moderate to severe hepatic impairment (Child-Pugh B or C).\n24. Major surgery within 8 weeks or minor surgery within 5 days before Cycle 1 Day 1. NOTE: Complete wound healing from major and minor surgery based on investigator discretion must have occurred prior to Cycle 1 Day 1.\n25. Major radiation therapy \\\u003C 14 days prior to Cycle 1 Day 1. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed \\\u003C 14 days prior to registration.\n26. Serious non-healing wound\u002Fulcer\u002Fbone fracture. NOTE: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions.\n27. Diagnosis of any other malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of trial therapy.\n28. Requirement for hemodialysis or peritoneal dialysis.\n29. History of solid organ or allogeneic stem cell transplant.\n30. Pregnant or breastfeeding. NOTE: breast milk cannot be stored for future use while the subject is being treated on study.\n31. History of severe allergic anaphylactic reactions to study drug or any of its' excipients.\n32. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.","ALL","18 Years",{"count":19,"type":20},44,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase II, single arm study. All subjects will receive Zanzalintinib 60 mg orally once daily until progression per RECIST 1.1 or intolerable toxicities or patient\u002Finvestigator decision to discontinue study therapy. Radiology imaging will be performed every 8 weeks for 3 timepoints then every 12 weeks thereafter. A window of ± 7 days may be applied to all study visits to accommodate observed holidays, inclement weather, scheduling conflicts etc.",[26],"Advanced Urothelial Carcinoma","NOT_YET_RECRUITING","2026-05-14",{"date":30,"type":31},"2026-05-18","ACTUAL",{"date":33,"type":20},"2026-06",{"date":35,"type":20},"2029-06",{"name":37,"class":38},"Guru Sonpavde","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100611531","phase-2-phase-ii-study-of-trastuzumab-rezetecan-or-in-combination-with-adebrelimab-in-her2-expressing-locally-advanced-or-metastatic-urothelial-carcinoma-lamuc-100611531","NCT07241793","Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC)","A Phase II Clinical Study of Trastuzumab Rezetecan (SHR-A1811) or in Combination With Adebrelimab (SHR-1316) for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la\u002FmUC)","TRAIN-UC-01","Inclusion Criteria:\n\n* Patients included in this study must meet all of the following criteria:\n\n  1. Age ≥ 18 years;\n  2. Histologically or cytologically confirmed HER2-expressing locally advanced unresectable (e.g., T4b, or N2-3) or metastatic urothelial carcinoma (la\u002FmUC), including bladder, ureter, renal pelvis, and urethra. HER2 expression is defined as immunohistochemical (IHC) staining results of 1+ to 3+, and must be confirmed by the pathology department of Sun Yat-sen University Cancer Center according to ASCO\u002FCAP guidelines.\n  3. Cohort 1: Patients who have received at least one prior systemic therapy, or relapsed\u002Fprogressed within 12 months after the last treatment, or who could not tolerate treatment due to adverse events (AEs). Cohort 2: Patients who have not received prior systemic therapy or relapsed\u002Fprogressed more than 12 months after neoadjuvant\u002Fadjuvant therapy, or those who could not tolerate treatment due to AEs. Cohort 3: Patients who have previously received platinum-based chemotherapy (including cisplatin, carboplatin, etc.), immunotherapy (including PD-1, PD-L1 inhibitors), and Disitamab Vedotin ;\n  4. At least one measurable target lesion according to RECIST 1.1 criteria;\n  5. ECOG performance status ≤ 2;\n  6. Adequate bone marrow, renal (calculated creatinine clearance \\> 30 mL\u002Fmin using the CG formula), hepatic, and coagulation function;\n  7. Expected survival ≥ 3 months;\n  8. The patient understands the study procedures and has provided written informed consent to participate in the study;\n  9. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first administration of the study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a blood pregnancy test is required.\n  10. Both male and female participants must agree to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year) and continue contraception until at least 180 days after the end of study treatment.\n\nExclusion Criteria:\n\n1. Locally advanced patients who are candidates for curative local treatment;\n2. Clinical history of cardiovascular, liver, respiratory, renal, hematological, endocrine, or neurological\u002Fpsychiatric diseases;\n3. Known or untreated spinal cord compression or active central nervous system metastases, except for those who have been treated and stable for at least 1 month and have discontinued corticosteroids for \\> 2 weeks;\n4. Known severe allergic reactions to the study drug's active ingredients and\u002For excipients, or allergy to humanized monoclonal antibody products (e.g., trastuzumab, pertuzumab);\n5. Received antitumor monoclonal antibody treatment within 4 weeks before the study start, or received other antitumor therapy without recovery from adverse events;\n6. Participated in any investigational drug treatment within 4 weeks before the study started;\n7. Known or suspected interstitial lung disease, or moderate to severe pulmonary diseases that might interfere with the evaluation of drug-related pulmonary toxicity, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia, bronchitis obliterans, pulmonary embolism, severe asthma, COPD, restrictive pulmonary diseases, or any autoimmune, connective tissue or inflammatory lung diseases, such as rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc., or a history of total lung resection;\n8. Known hereditary or acquired bleeding disorders (e.g., hemophilia, coagulopathy);\n9. Received spinal cord radiation or has not recovered from radiation-related adverse events within 4 weeks before study start;\n10. Diagnosed with immunodeficiency or received systemic corticosteroid treatment or any other immunosuppressive therapy within 7 days before the first study drug administration. Physiological doses of corticosteroids (≤10 mg\u002Fday of prednisone or equivalent) are allowed;\n11. Active autoimmune diseases requiring systemic treatment within the past 2 years (e.g., requiring disease-modifying drugs, corticosteroids, or immunosuppressants). Replacement therapies (e.g., thyroid hormones, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments. A history of non-infectious pneumonia requiring corticosteroid treatment or current interstitial lung disease within 1 year before the first dose is excluded;\n12. History of organ or hematopoietic stem cell transplantation;\n13. Known HIV infection (HIV 1\u002F2 positive);\n14. Untreated active hepatitis B (HBV). Note: Hepatitis B carriers with an HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) before the first dose are eligible, but should receive antiviral therapy during chemotherapy to prevent reactivation.\n\n    For anti-HBc (+), HBsAg (-), anti-HBs (-), and undetectable HBV viral load subjects, preventive antiviral therapy is not required, but close monitoring is necessary.\n15. Active hepatitis C (HCV) infection (HCV antibody positive and HCV RNA level above detection threshold;\n16. Received live vaccines within 30 days before the first dose of the study drug. Note: Inactivated flu vaccines are allowed within 30 days before the first dose, but live attenuated flu vaccines are not permitted.\n17. History of other malignancies within the past 3 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or low-risk prostate cancer (T2N0M0, Gleason score \\\u003C7, or undetectable PSA);\n18. Any condition or disease history that may interfere with the study results or hinder the participant's full participation, including abnormal laboratory values, or situations deemed inappropriate by the investigator;\n19. Breastfeeding women.",{"count":48,"type":20},96,[23],"This is a multicenter, open-label, Phase II clinical trial to evaluate the efficacy and safety of Trastuzumab Rezetecan (SHR-A1811) or in combination with Adebrelimab (SHR-1316) for HER2-expressing locally advanced or metastatic urothelial carcinoma (la\u002FmUC).",[52,26,53],"Urothelial Carcinoma","Urothelial Carcinoma Recurrent",[55,56,57],"Urothelial carcinoma","Antibody-Drug Conjugate","immune checkpoint inhibitor","RECRUITING","2026-04-29",{"date":61,"type":31},"2026-04-30",{"date":63,"type":31},"2025-11-20",{"date":65,"type":20},"2031-07-01",{"name":67,"class":38},"Sun Yat-sen University",6,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100510653","phase-1-a-study-of-fx-909-in-patients-with-advanced-solid-malignancies-including-advanced-urothelial-carcinoma-100510653","NCT05929235","A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma","A Phase 1, First-in-Human, Dose-Escalation and Expansion Study of FX-909 (as Monotherapy or in Combination With Pembrolizumab) in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma","Part A\u002FB Inclusion Criteria:\n\n1. Able to understand and willing to sign an informed consent.\n2. Age ≥ 18 years.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.\n4. An archival, paraffin-embedded, formalin-fixed, tumor sample (see Laboratory Manual for details) that in Part A is no more than 30 months old at the time of screening or in Part B is no more than 30 months old at time of pre-screening. If an archival tumor sample is not available or is older than 30 months, then the patient must consent to provide a fresh biopsy during screening.\n5. Part A: Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid malignancies that have progressed after all available standard therapy for the specific tumor type, or for which no standard therapy exists. Patients for whom standard therapies are intolerable or considered inappropriate by the Investigator are eligible.\n\n   Part B: Patients with histologically or cytologically confirmed, locally advanced (unresectable) or metastatic urothelial carcinoma exhibiting high levels of PPARG protein expression will be prospectively enrolled in this study. Eligibility will require a Tumor Positivity Score (TPS) of ≥ 60%, as determined by an investigational immunohistochemistry (IHC) assay for PPARG.\n\n   • Treated with ≤ 4 prior therapies for advanced or metastatic disease Patients in Part B must have progressed after all available standard therapy, been unable to tolerate standard therapy, or be considered inappropriate for standard therapy by the Investigator.\n6. Part A: Patients with or without measurable disease (as defined by RECIST version 1.1) will be eligible for enrollment.\n\nPart B: Patients must have measurable disease per RECIST version 1.1 with ≥ 1 site of measurable disease that has not been previously irradiated or has progressed after radiation therapy.\n\n7\\. Screening laboratory values meet the criteria outlined in Table 8.\n\no Hematologic criteria may be met with transfusion of blood products or administration of G-CSF, provided they are not given within 7 days prior to enrollment. Hematologic parameters must meet the inclusion criteria prior to dosing on Cycle 1 Day 1.\n\nPart A\u002FB Exclusion Criteria:\n\n1. Female patients who are pregnant (confirmed with a positive pregnancy test) or breastfeeding.\n2. Prior anticancer chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug administration. When the most recent therapy was a biological therapy (including antibody-drug conjugates), an immune-checkpoint inhibitor (eg, anti-PD(L)1 or anti-CTLA4), or immune agonist, patients should wait 4 weeks before starting therapy with FX-909. (See Exclusion Criterion 6 for required radiotherapy windows.)\n3. Prior therapy directly inhibiting PPARG or RXRA.\n4. Adverse events from prior therapy that have not returned to baseline or stabilized at Grade 1 (except alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade ≤ 2 neuropathy) prior to study drug administration.\n5. Prior major surgery (excluding placement of vascular access) within 4 weeks before study drug administration.\n6. Prior radiation therapy with an inadequate washout between the last dose and the start of study drug, defined as follows: 1) at least 2 weeks for palliative radiation to the extremities for osseous bone metastases is required; and 2) at least 4 weeks for radiation to non-extremity sites is required.\n7. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, melanoma in situ status-post full-thickness resection without recurrence, Stage 1 uterine cancer, localized prostate cancer that has been treated surgically with curative intent and presumed cured, or other malignancies with an expected curative outcome. Patients requiring adjuvant therapy within the past 2 years for another malignancy will not be considered to have been cured.\n8. QT interval corrected using Fridericia's Formula (QTcF) \\>470 msec in screening, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives.\n9. Known active diagnosis of lipodystrophy\u002Flipoatrophy, or an ongoing need to receive medications known to cause lipodystrophy\u002Flipoatrophy.\n10. Any active uncontrolled systemic bacterial, viral, or fungal infection requiring treatment.\n11. Known history of HIV seropositivity. Those who have no detectable viral load on highly active antiretroviral therapy (HAART) are permitted.\n12. Patients with chronic hepatitis B virus (HBV) infection. Patients are permitted with either universal prophylaxis or a pre-emptive treatment approach consistent with regional or national guidelines for patients who receive anticancer therapies.\n13. Active hepatitis C virus (HCV) infection. Those who have completed curative therapy for HCV and have no detectable viral load are permitted.\n14. Prior diagnosis of chronic or recurrent (\\> 1 episode) pancreatitis at any time or a diagnosis of acute pancreatitis within the 6 months prior to screening.\n15. Significant impairment of lung function indicated by resting oxygen saturations below 92% on room air or requiring chronic use of ambulatory supplemental oxygen.\n16. Uncontrolled or symptomatic central nervous system (CNS) metastases, leptomeningeal disease, or carcinomatous meningitis. Asymptomatic brain metastasis is allowed if they have been stable after appropriate radiotherapy for 1 month.\n17. Need for treatment with high doses of oral or intravenous steroids (\\> 10 mg\u002Fday prednisone or equivalent). Physiologic doses of corticosteroids for treatment of endocrinopathies may be continued if the patient is on a stable dose for at least 1 month.\n18. Need or anticipated need for treatment with a prohibited therapy during the treatment phase of this study.\n19. Concurrent participation in any other investigational therapeutic study.\n20. History of any of the following cardiovascular diseases:\n\n    o Recent history (within the 6 months prior to screening) of serious uncontrolled cardiac arrhythmia (including atrial fibrillation without adequate rate control) or clinically significant ECG abnormalities including second-degree (Type II) or third-degree atrioventricular node block\n\n    o Documented cerebrovascular event (stroke or transient ischemic attack), cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the 6 months prior to enrollment\n    * Congestive heart failure (Class III or IV) as defined by the New York Heart Association functional classification system\n    * Recent history (within the past 6 months) of symptomatic pericarditis\n21. Thromboembolic events and\u002For bleeding disorders ≤ 28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug.\n22. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the study or would jeopardize compliance with the protocol.\n23. Patients with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and\u002For injectable agents other than insulin (as defined by HbA1c and fasting plasma glucose criteria in Table 8. Patients taking insulin are excluded from the study. Medication for type 2 diabetes mellitus should have remained stable for the past 14 days prior to screening).\n24. Known hypersensitivity to FX-909 or any of its excipients.\n25. Patients with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication.\n26. Patient is or has an immediate family member (eg, spouse, parent\u002Flegal guardian, sibling, or child) who is a member of the study site or Sponsor staff directly involved with this study, unless prospective Institutional Review Board (IRB) or Ethics Committee (EC) approval (by chair or designee) is given allowing exception to this criterion for a specific patient.\n27. Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before study entry.\n28. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.\n\nPart 1A1 Inclusion Criteria:\n\n1\\. Able to understand and willing to sign an informed consent 2. Aged 18 years or older on the day written informed consent is given 3. ECOG performance status 0 or 1 4. Histologically or cytologically confirmed, locally advanced (unresectable) or metastatic urothelial carcinoma by pathology report.\n\n5\\. Participants must have received and progressed after all available standard therapies known to confer clinical benefit, been unable to tolerate standard therapy, or be considered inappropriate for standard therapy by the Investigator.\n\n6\\. Must have progressed on treatment with an anti-PD-1\u002FL1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:\n\n1. Received at least 2 doses of an approved anti-PD-1\u002FL1 mAb.\n2. Documented disease progression after anti-PD-1\u002FL1 treatment (consistent with the principles of RECIST v1.1). The initial evidence of disease progression is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression (as defined in 2.c).\n3. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb.\n\n   1. Progressive disease is determined consistent with the principles of RECIST v1.1.\n   2. This determination is made by the investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.\n\n   7\\. Measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n\n   8\\. Archival tumor tissue sample within 30 months of enrollment or newly obtained \\[core, incisional, OR excisional\\] biopsy of a tumor lesion not previously irradiated has been provided.\n\n   9\\. Participants who have AEs due to previous anticancer therapies (with the exception of alopecia or peripheral sensory neuropathy) must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible, as are participants with ≤Grade 2 neuropathy, hearing loss, or alopecia.\n\n   10\\. If male, agrees to use an adequate method of contraception starting with the first dose of study drug through 90 days after the last dose of study drug. Please see Section 10.3 for a list of acceptable birth control methods. Male participants must not donate sperm throughout the study period and for 90 days after the last dose of the study treatment.\n\n   11\\. Female participants of childbearing potential must have a negative serum pregnancy test at screening within 7 days of the Cycle 1 Day 1 dosing. Female participants of childbearing potential must agree to use a highly effective form of contraception, as defined in the protocol (Section 10.3), during the study and for 120 days after the last dose of study drug. To be considered NOT of childbearing potential, female participants must have had a hysterectomy or bilateral oophorectomy or be 1-year post-menopause or have had amenorrhea for a period of 12 months or longer in the absence of chemotherapy, anti-estrogens, or ovarian suppression.\n\n   12\\. HIV-infected participants must have well controlled HIV on ART, defined as:\n\n\u003C!-- -->\n\n1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n2. Participants on ART must have achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months\n4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study.\n5. Participants with HIV should continue ongoing management by their health care provider(s), including monitoring of HIV viral load, CD4+ T-cell count, and appropriate supportive care measures.\n\n   13\\. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.\n\na. Hepatitis B screening tests are not required unless:\n\n1. Known history of HBV infection\n2. As mandated by local guidelines\n\n14\\. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization.\n\n1. Hepatitis C screening tests are not required unless:\n\n   3\\. Known history of HCV infection 4. As mandated by local guidelines 15. Adequate organ function as defined in Table 20.\n\nPart 1A1 Exclusion Criteria:\n\n1. HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n2. Participants with type 1 diabetes mellitus, or type 2 diabetes mellitus that is not adequately controlled with diet, exercise, or oral hypoglycemic agents and\u002For injectable agents other than insulin (as defined by HbA1c and fasting plasma glucose criteria in Table 20. Participants taking insulin are excluded from the study. Medication for type 2 diabetes mellitus should have remained stable for the past 14 days prior to screening).\n3. Participants with gastrointestinal disorders that may interfere with the ability to swallow tablets or absorb study medication.\n4. Thromboembolic events and\u002For bleeding disorders ≤28 days (eg, deep vein thrombosis or pulmonary embolism) prior to the first dose of study drug.\n\n   Prior\u002FConcomitant Therapy\n5. Prior therapy inhibiting PPARG or RXRA.\n6. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n7. Received prior systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) before the start of study drug administration. When the most recent therapy was a biological therapy (including antibody-drug conjugates), an immune-checkpoint inhibitor (eg, anti-PD(L)1 or anti-CTLA4), or immune agonist, participants should wait 4 weeks before starting therapy with FX-909.\n8. Note: If participant underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n9. Received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids.\n10. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n11. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n\n    Prior\u002FConcurrent Clinical Study Experience\n12. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n\n    Diagnostic Assessments\n13. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n14. Prior diagnosis of chronic or recurrent (\\> 1 episode) pancreatitis at any time or a diagnosis of acute pancreatitis within the 6 months prior to screening,\n15. Significant impairment of lung function indicated by resting oxygen saturations below 92% or requiring chronic use of ambulatory supplemental oxygen.\n16. Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n17. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n18. Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n19. Active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine or physiologic corticosteroid).\n20. History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n21. Any active bacterial, viral, or fungal infection requiring systemic therapy.\n22. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n23. Severe hypersensitivity (≥Grade 3) to FX-909 and pembrolizumab and\u002For any of its excipients.\n\n    Other Exclusions\n24. History of stem cell\u002Fsolid organ transplant.\n25. Participants who have not adequately recovered from major surgery or have ongoing surgical complications.\n26. Need or anticipated need for treatment with a prohibited therapy described in Section 21.11.2 during the treatment phase of this study\n27. If female, is pregnant, breastfeeding, or expecting to conceive, or if male, expect to father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.\n28. Participant is or has an immediate family member who is a member of the study site or Sponsor staff directly involved with this study, unless prospective IRB or EC approval is given allowing exception to this criterion.\n29. Participants with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n30. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the participant's safety or study results.",{"count":77,"type":20},120,[79],"PHASE1","The goal of this clinical trial is to study the safety and tolerability in all advanced solid tumors, including advanced urothelial carcinoma.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Is FX-909 safe and tolerable, as a monotherapy and in combination with Pembrolizumab\n* What is the right dose level for patients\n\nParticipants will be asked to take FX-909 daily in tablet form, or FX-909 daily and Pembrolizumab every 3 weeks, and record any outcomes from taking the drug. Participants will also be asked to return for multiple site visits for various blood tests and to collect blood and tumor samples as well as have regular CT\u002FMRI scans.",[26,82,83],"Oral Drug Administration","Open Label","2026-04-16",{"date":86,"type":31},"2026-04-20",{"date":88,"type":31},"2023-08-24",{"date":90,"type":20},"2028-01-30",{"name":92,"class":93},"Flare Therapeutics Inc.","INDUSTRY",12,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100610004","phase-2-pembrolizumab-maintenance-after-enfortumab-vedotin-evpembro-induction-in-front-line-metastatic-urothelial-carcinoma-100610004","NCT07221942","Pembrolizumab Maintenance After Enfortumab Vedotin (EV)\u002FPembro Induction in Front-Line Metastatic Urothelial Carcinoma","Pembrolizumab Maintenance After Enfortumab Vedotin\u002FPembrolizumab Induction in Front-Line Metastatic Urothelial Carcinoma","IMPROEV","Inclusion Criteria:\n\n* Patients must have histologically and radiographically confirmed locally advanced, unresectable urothelial carcinoma.\n* Patients should not have received prior systemic therapy for metastatic disease.\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria v1.1\n* Patients may have received prior neoadjuvant or adjuvant immune checkpoint inhibitor therapy for localized disease and are eligible if they completed the treatment ≥12 months prior to initiating treatment on this clinical trial.\n* ECOG performance status 0-2\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n* Archival tumor biospecimen (when available) must be procured for correlative evaluation. If tumor tissue is not available or accessible despite good faith efforts, patient may still be treated on study. Formalin fixed, paraffin embedded (FFPE) tissue block(s) or at least 25 unbaked, unstained slides are required. Tissue samples taken from a metastatic lesion prior to the start of screening are acceptable.\n* Normal organ and marrow function as defined below.\n\n  * Absolute neutrophil count \\> 1,000\u002Fmm3 unless patient has constitutional neutropenia\n  * Platelets \\> 100,000\u002Fµl\n  * Hemoglobin \\> 8.0 g\u002FdL\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5 x upper limit of normal (ULN) or \\\u003C3.5 x ULN if liver metastases\n  * Creatinine Clearance \\>20 ml\u002Fmin\n\nExclusion Criteria:\n\n* Patients who have received prior monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs) for urothelial cancer.\n* Grade 2 or higher baseline sensory or motor neuropathy.\n* Uncontrolled diabetes (HbA1c \\>8%)\n* Patients with uncontrolled and untreated central nervous system (CNS) metastases.\n\n  * Prior radiation to CNS metastases is permitted.\n  * Prior history of CNS disease that has responded to previous systemic therapy is permitted only if no recurrence.\n  * Patient should not have leptomeningeal disease\n  * CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged metastasis.\n  * If requiring steroid treatment for CNS metastases, the patient is on stable dose \\\u003C 10 mg\u002Fday of prednisone or equivalent for at least 2 weeks prior to starting treatment\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active untreated infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic uncontrolled cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, would substantially impair the patient's ability to comply with study requirements. Efforts should be made to provide reasonable accommodations before determining exclusion based on social limitations.\n* Subjects with a history of another invasive malignancy within 3 years before the first dose of study drug that cannot be watched and requires treatment, or any evidence of residual disease from a previously diagnosed malignancy that cannot be watched and requires treatment. Adjuvant hormonal therapy for breast cancer is allowed.\n* Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.\n* Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with enfortumab vedotin.\n* History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Prior allogeneic stem cell or solid organ transplant.\n* Other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up; any known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.\n* Patients with active tuberculosis.\n* Pregnant or breast feeding\n* History of autoimmune diseases. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n\n  * Patients with vitiligo or residual autoimmune hypothyroidism on stable doses of hormone replacement are permitted to enroll.\n  * Patients with type 1 diabetes mellitus (T1DM) on a stable dose of insulin are permitted to enroll.\n  * Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* On high dose steroids at the time of study enrollment, defined as \\>10 mg prednisone (or bioequivalent), including steroids used for management of intracranial lesions. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n* Patients who received prior immunotherapy for mUC or for an alternative malignancy are eligible unless they developed an immune related adverse event while on therapy requiring cessation of therapy or use of disease modifying agents, corticosteroids, or immunosuppressive drugs.",{"count":104,"type":20},97,[23],"This is a single-arm, open-label, non-randomized Phase II trial evaluating the efficacy of induction therapy with enfortumab vedotin (EV) plus pembrolizumab (P) for 18 weeks (6 cycles), followed by maintenance pembrolizumab in treatment-naïve patients with metastatic urothelial carcinoma (mUC). Approximately 97 patients will be enrolled. Induction consists of EV (1.25 mg\u002Fkg IV on Days 1 and 8 of each 21-day cycle; starting dose of 1 mg\u002Fkg allowed) and P (200 mg IV on Day 1 of each cycle). Radiographic assessments occur after 3 and 6 cycles. Patients achieving complete or partial response transition to maintenance P (400 mg IV every 6 weeks or 200 mg IV every 3 weeks) for up to 2 years. Dose modifications for EV are permitted per protocol; no dose adjustments for P. Treatment continues until disease progression, unacceptable toxicity, or completion of maintenance therapy. Patients will enter long-term or survival follow-up as applicable.",[108,109,26],"Metastatic Urothelial Carcinoma","Unresectable Urothelial Carcinoma",[55],"2026-02-17",{"date":113,"type":31},"2026-02-19",{"date":115,"type":31},"2026-01-23",{"date":117,"type":20},"2029-09-03",{"name":119,"class":38},"Fox Chase Cancer Center",1,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100621740","phase-2-sys6002-vs-padcev-in-patients-with-advanced-urothelial-carcinoma-100621740","NCT07374549","SYS6002 vs PADCEV in Patients With Advanced Urothelial Carcinoma","A Randomized, Open-Label, Controlled, Multicenter Phase 2 Trial of SYS6002 Versus PADCEV in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n* 1\\. Patients aged 18-80 years (inclusive);\n* 2\\. Pathologically confirmed patients with advanced urothelial carcinoma who have received a platinum-based chemotherapy with anti-PD-(L)1 agent. For those who received these therapies in the adjuvant or neoadjuvant setting, disease progression must have occurred during treatment or within 12 months of treatment completion;\n* 3 An archival tumor tissue sample or a fresh tissue sample should be provided;\n* 4 Subjects must have measurable disease according to RECIST (version 1.1);\n* 5 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n* 6 Life expectancy of ≥ 3 months;\n* 7 Major organ function must meet the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment;\n* 8Sexually active fertile subjects must agree to use methods of contraception during the study and at least 7 months after termination of study therapy and have a negative urine or serum pregnancy test within 7 days prior to randomization;\n* 9.Willing to participate in the study, understand the study procedures, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1.Active central nervous system metastases or leptomeningeal metastasis;\n* 2.Adverse events from prior anti-tumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk)；\n* 3.Any serious and\u002For uncontrolled concurrent illness that may interfere with patient's participation in the study:\n\n  1. Participants with a history of severe cardiovascular disease within 6 months prior to randomization, including but not limited to:\n\n     Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia and third-degree atrioventricular block requiring clinical intervention; corrected QT interval \\> 480 ms by Fridericia method (Fridericia formula: QTcF = QT\u002FRR\\^0.33, RR = 60\u002Fheart rate); With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; New York Heart Association (NYHA) classification Grade III and above heart failure, and left ventricular ejection fraction (LVEF) \\\u003C 50% in the tests and examinations during the screening period; cerebrovascular accidents; pulmonary embolisms;\n  2. Other clinically significant diseases:\n\nHbA1c \\> 8%; Participants with active keratitis and corneal ulcer, or fundus lesions with a risk of blindness; Grade ≥2 neuropathy prior to randomization; Severe infection within 4 weeks prior to randomization; active infection requiring systemic antibiotics, antiviral, or antifungal therapy within 2 weeks prior to randomization; Active HBV or HCV infection; History of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; History of another malignancy within 3 years prior to randomization; History of interstitial lung disease (ILD) \u002F non-infectious pneumonia, or current ILD\u002Fnon-infectious pneumonia, or imaging findings at screening that cannot rule out these conditions, except for those who are determined to be risk-free after discussion between the investigator and the sponsor; Pleural effusion, ascites or pericardial effusion with symptoms or requiring puncture or drainage within 2 weeks prior to randomization;\n\n* 4.Use of other unmarketed clinical investigational drugs or treatments, chemotherapy, radiotherapy targeted therapy within 4 weeks prior to randomization; use of traditional Chinese medicine with anticancer indication, oral fluoropyrimidine drugs, small molecule targeted drug within 2 weeks prior to randomization; use of palliative radiation or local therapy within 2 weeks prior to randomization;with major surgery within 4 weeks prior to randomization;\n* 5.Allergy to any component of SYS6002, or humanized monoclonal antibodies; investigator-determined ineligibility for enfortumab vedotin therapy.\n* 6\\. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.","80 Years",{"count":130,"type":20},100,[23],"This study is a randomized, open-label, controlled, multicenter phase II clinical trial, which aims to evaluate the safety and efficacy of SYS6002 versus enfortumab vedotin in the treatment of participants with advanced urothelial carcinoma.\n\nThis study has not yet been submitted for ethical review. The current registration is a pre-registration. Recruitment will be initiated only after formal approval is obtained from the relevant Ethics Committee or Institutional Review Board.",[26],"2026-01-21",{"date":136,"type":31},"2026-01-29",{"date":138,"type":20},"2026-06-20",{"date":140,"type":20},"2028-12-01",{"name":142,"class":93},"CSPC Megalith Biopharmaceutical Co.,Ltd.",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":120},"100572821","phase-3-a-phase-iii-study-of-shr-a2102-versus-investigator-selected-therapy-in-advanced-urothelial-carcinoma-100572821","NCT06738251","A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma","A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A2102 for Injection Versus Investigator-selected Therapy in Locally Advanced or Metastatic Urothelial Carcinoma Previously Treated With Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors and With or Without ADC","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.\n2. 18 to 80 years old (including boundary value), gender is not limited.\n3. ECOG performance status score of 0 or 1.\n4. Estimated survival ≥ 3 months.\n5. Pathologically confirmed urothelial carcinoma confirmed by imaging or other methods as locally advanced unresectable or metastatic disease.\n6. Patients with locally advanced or metastatic disease who have previously received both a platinum-based chemotherapy regimen and a PD-(L)1 inhibitor; patients who received platinum-based chemotherapy and\u002For a PD-(L)1 inhibitor as neoadjuvant or adjuvant therapy and experienced recurrence or progression during treatment or within 6 months after completing treatment will be considered to have received these therapies in the locally advanced\u002Fmetastatic setting.\n7. Imaging-confirmed disease progression during or after treatment with the most recent regimen.\n8. Able to provide preserved or fresh tumor tissue.\n9. Must be present with at least one measurable lesion according to RECIST v1.1 criteria.\n10. Good level of organ function.\n11. Male subjects whose partners are women of childbearing potential and female subjects of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 8 months after the last dose of the trial drug.\n\nExclusion Criteria:\n\n1. Planned to receive any other anti-tumor therapy during this trial.\n2. Receipt of other unmarketed clinical trial drugs or treatments within 4 weeks prior to randomization.\n3. Received systemic anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to randomization, and palliative radiotherapy or local therapy within 2 weeks prior to the first use of the investigational drug.\n4. Prior receipt of antibody-drug conjugates containing topoisomerase I inhibitors in the composition.\n5. For locally advanced or metastatic disease: patients who have previously received more than three lines of systemic therapy in this setting.For neoadjuvant or adjuvant therapy: if the disease recurs or progresses during treatment or within 6 months after its completion, the patient is considered to have received first-line systemic therapy for locally advanced or metastatic disease.\n6. Prior treatment with more than 1 antibody-drug conjugate.\n7. Major surgery other than diagnosis or biopsy within 4 weeks prior to randomization that requires elective surgery during the trial.\n8. Received systemic glucocorticoids (prednisone \\> 10 mg\u002Fday or equivalent dose) or other immunosuppressants within 14 days prior to the first use of investigational drug or randomization for immunosuppressive purposes.\n9. Adverse events from prior antineoplastic therapy did not recover to Grade ≤1 according to NCI-CTCAE v5.0.\n10. Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active central nervous system metastases. CNS metastases that have been adequately treated and whose neurological symptoms are able to return to baseline at least 4 weeks prior to randomization (with the exception of residual signs or symptoms associated with CNS treatment) may be enrolled in the study.\n11. Subject has a serous effusion with clinical symptoms or requiring puncture and drainage.\n12. Any malignancy diagnosed within 5 years prior to randomization (calculated from the date of the last anti-tumor treatment), except:Localized, low-risk prostate cancer.Papillary thyroid carcinoma, basal-cell carcinoma, or squamous-cell carcinoma of the skin that has been adequately treated and shows no evidence of disease.Other carcinomas in situ that have been adequately treated and show no evidence of disease recurrence.\n13. History of interstitial pneumonitis\u002Finterstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required systemic corticosteroid therapy.Current evidence, in the investigator's judgment, of uncontrolled interstitial pneumonitis\u002Finterstitial lung disease, non-infectious pneumonitis, or any other active pneumonitis.\n14. Severe infections requiring intravenous antibiotics, antivirals, or antifungals for control.\n15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n16. Has a history of immunodeficiency or organ transplantation.\n17. Any serious arterial or venous thrombotic event within 6 months before randomization.\n18. Those who have had significant clinically significant bleeding symptoms within 3 months before the first study drug.\n19. Glycosylated hemoglobin (HbA1c) ≥8%.\n20. Have severe cardiovascular and cerebrovascular diseases.\n21. Allergic reaction to any component of this study treatment.\n22. Female subjects who are pregnant or plan to become pregnant during the study.\n23. According to the judgment of the investigator, there are concomitant diseases (such as thyroid disease and mental illness, etc.) or any other conditions that seriously endanger the safety of the patient, or affect the patient's completion of this study.\n24. Prior treatment for urothelial carcinoma with all chemotherapy agents included in the control-arm regimen.",{"count":151,"type":20},402,[153],"PHASE3","To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.",[26],"2025-07-16",{"date":158,"type":31},"2025-07-17",{"date":160,"type":31},"2025-02-12",{"date":162,"type":20},"2027-09",{"name":164,"class":93},"Shanghai Hengrui Pharmaceutical Co., Ltd.",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":120},"100595561","phase-1-clofarabine-therapy-in-locally-advanced-or-metastatic-urothelial-carcinoma-100595561","NCT07034053","Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma","Clofarabine Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1\u002F2 Dose-Escalation Study","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease\n* Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) greater than or equal to 1500.\n* White blood cell (WBC) count greater than 3.0.\n* Platelets greater than or equal to 100.\n* Hemoglobin greater than 9.0 g\u002FdL.\n* Adequate hepatobiliary function as indicated by the following laboratory values: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Adequate renal function as indicated by the following laboratory values: Serum creatinine ≤ 1.0 mg\u002FdL; if serum creatinine \\> 1.0 mg\u002FdL, then the estimated glomerular filtration rate (GFR) must be \\> 60 mL\u002Fmin\u002F1.73 m\\^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation\n* Adequate cardiac function (NYHA cardiac III-IV excluded)\n* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Received previous treatment with clofarabine\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy\n* Prior radiation therapy to the pelvis\n* Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days\n* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. In particular: a) New York Heart Association classification stage II, III, or IV congestive heart failure; b) Coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infraction) within 3 months of first dose of study drug; c) Any other primary cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.\n* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).\n* Any medical condition that requires chronic use of oral high-dose corticosteroids (in excess of 1 mg\u002Fkg\u002Fday) (low-dose corticosteroid for pre-medication purposes are allowed).\n* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results\n* Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed\n* Had currently active gastrointestinal disease, or prior surgery that might affect the ability of the participants to absorb oral Clofarabine.\n* Had prior treatment with a known nephrotoxic drug within 2 weeks of the first dose of study drug, unless the participants had a calculated GFR \\>30 at 2 time points no \\\u003C7 days apart during the 2- week period prior to the first dose of study drug.\n* Positive human immunodeficiency virus (HIV) test.\n* Female patients who are pregnant\u002Fbreastfeeding.",{"count":173,"type":20},50,[79,23],"This phase 1\u002F2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.",[26,177],"Metastatic Urothelial Cancer","2025-06-23",{"date":180,"type":31},"2025-06-26",{"date":182,"type":31},"2023-10-24",{"date":184,"type":20},"2028-11",{"name":186,"class":38},"Ekaterina Laukhtina",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":120},"100531203","phase-3-a-study-to-evaluate-9mw2821-versus-chemotherapy-in-subjects-with-previously-treated-locally-advanced-or-metastatic-urothelial-cancer-100531203","NCT06196736","A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer","An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Have Previously Received PD-(L)1 Inhibitor and Platinum-containing Chemotherapy","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Male or female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed locally advanced or metastatic urothelial cancer, not amenable to resection with curative intent.\n5. Subject must have received a platinum containing chemotherapy and PD-(L)1 inhibitor in the metastatic\u002Flocally advanced setting. If platinum and\u002For PD-(L)1 inhibitor was administered in the adjuvant\u002Fneoadjuvant setting subject must have progressed during treatment or within 12 months of completion.\n6. Subject must have experienced radiographic progression during or after the last treatment regimen.\n7. An archival tumor tissue sample or a fresh tissue sample should be provided.\n8. Life expectancy of ≥ 12 weeks.\n9. Subjects must have measurable disease according to RECIST (version 1.1).\n10. Adequate organ functions.\n11. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n12. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received prior chemotherapy with all available study therapies in the control arm, any strong CYP3A4 inducers\u002Finhibitors within 14 days prior to the first dose of study drug.\n2. Preexisting treatment related toxicity Grade ≥ 2 (except alopecia and grade 2 endocrine system toxicity with stable replacement therapy).\n3. Major surgery within 28 days prior to first dose of study drug.\n4. Hemoglobin A1C (HbA1c) ≥ 8%.\n5. Preexisting peripheral neuropathy Grade ≥ 2.\n6. Any live vaccines within 28 days before first dose of study drug or during the study.\n7. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n8. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.\n9. Central nervous system metastases.\n10. History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.\n11. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.\n12. Has ocular conditions that may increase the risk of corneal epithelium damage.\n13. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n14. Uncontrolled tumor-related bone pain or spinal cord compression. Patients requiring pain medication must be on a stable regimen for at least 2 weeks before the first dose of study drug.\n15. Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.\n16. Condition or situation which may put the subject at significant risk.","75 Years",{"count":196,"type":20},432,[153],"The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.",[26],"2025-04-10",{"date":202,"type":31},"2025-04-13",{"date":204,"type":31},"2023-12-29",{"date":206,"type":20},"2027-07",{"name":208,"class":93},"Mabwell (Shanghai) Bioscience Co., Ltd.",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100585608","phase-2-probiotics-in-advanced-urothelial-carcinoma-100585608","NCT06904573","Probiotics in Advanced Urothelial Carcinoma","A Multicenter, Randomized Controlled Phase II Study of Evaluating the Efficacy and Safety of Immunotherapy Combined With Oral Probiotics Compound (Biolosion) in Patients With Advanced Urothelial Carcinoma","IMPROVE","Inclusion Criteria:\n\n* Patients included in this study must meet all of the following criteria:\n\n  1. Aged 18 or above;\n  2. Histologically or cytologically confirmed locally advanced inoperable (such as T4b, or N2-3) or metastatic urothelial carcinoma, including bladder, ureter, renal pelvis and urethra;\n  3. Patients who have received previous treatment with immune checkpoint inhibitors (PD-1\u002FPD-L1 monoclonal antibodies) are allowed;\n  4. According to RECIST1.1 standard, there is at least one measurable target lesion;\n  5. ECOG score ≤2;\n  6. Good bone marrow, kidney (serum creatinine clearance calculated by CG formula\\> 30 mL\u002Fmin), liver and coagulation function:\n  7. Expected survival period ≥ 6 months;\n  8. The patient understands the research procedures and signs the informed consent form in writing to indicate his\u002Fher agreement to participate in the study;\n  9. Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 7 days before the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required.\n  10. If there is a risk of pregnancy, male and female patients should use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue for at least 180 days after stopping the trial treatment.\n\nExclusion Criteria:\n\n* Any of the following will be considered as meeting the exclusion criteria of the study:\n\n  1. Patients with locally advanced disease may receive local radical treatment;\n  2. History of clinically symptomatic cardiovascular, liver, respiratory, renal, hematoendocrine, or neuropsychiatric diseases;\n  3. Clear brain\u002Fmeningeal metastasis;\n  4. Peripheral neuropathy \\>1 degree;\n  5. Patients who have received anti-tumor monoclonal antibody treatment within 4 weeks before the start of the study, or have received other anti-tumor drug treatment and have not recovered from adverse events\u002Freactions;\n  6. Participated in any investigational drug treatment within 4 weeks before the start of treatment;\n  7. Patients who had received axial bone radiotherapy within 4 weeks before the start of the study or had not recovered from adverse reactions caused by previous radiotherapy;\n  8. Known severe allergic reaction to the study drug, its active ingredients and\u002For any excipients;\n  9. Patients diagnosed with immunodeficiency or receiving systemic glucocorticoids or any other form of immunosuppressive therapy within 7 days before the first dose of the study; physiological doses of glucocorticoids (≤10 mg\u002Fday of prednisone or equivalent drugs) are allowed;\n  10. Active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years before the first dose. Replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose or current interstitial lung disease;\n  11. Received solid organ or blood system transplantation;\n  12. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive). Untreated active hepatitis B;\n  13. Untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: HBV viral load must be \\\u003C1000 copies\u002Fml (200 IU\u002Fml) before the first dose, and subjects should receive anti-HBV treatment during the entire study chemotherapy treatment to avoid viral reactivation. For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), preventive anti-HBV treatment is not required, but viral reactivation needs to be closely monitored;\n  14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit) received live vaccine within 30 days before the first dose (Cycle 1, Day 1);\n  15. A history of other malignant tumors in the past 5 years, excluding cured non-malignant melanoma of the skin, cervical carcinoma in situ, and incidentally discovered prostate cancer (stage lower than T2N0M0, Gleason score \\\u003C7, or undetectable PSA);\n  16. Medical history or disease evidence, abnormal treatment or laboratory test values, or other conditions that the researcher considers unsuitable for enrollment that may interfere with the trial results or prevent the subject from fully participating in the study;\n  17. Breastfeeding women\n  18. People with chronic diseases who need to take antibiotics for a long time.",{"count":218,"type":20},222,[23],"This is a multicenter, randomized, controlled phase II Study of evaluating the efficacy and safety of immunotherapy combined with probiotics compound (Biolosion) in patients with advanced urothelial carcinoma.",[26,222,223],"Probiotics","Immunotherapy","2025-03-28",{"date":226,"type":31},"2025-04-01",{"date":228,"type":31},"2025-01-01",{"date":230,"type":20},"2028-01-01",{"name":67,"class":38},3,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":120},"100565220","phase-1-a-trial-of-shr-a2102-with-antitumor-therapy-in-advanced-urothelial-carcinoma-100565220","NCT06639347","A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma","An Open Label, Multicenter, Phase Ib\u002FIl Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an informed consent form.\n2. Male or female subjects must be age 18 or older.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Subjects must have histologically documented, unresectable locally advanced or\n5. Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.\n6. An archival tumor tissue sample or a fresh tissue sample should be provided.\n7. Subjects must have measurable disease according to RECIST (version 1.1).\n\nExclusion Criteria:\n\n1. Subjects with not adequately treated, or uncontrollable , or active CNS metastases.\n2. Subjects who have previously received TOPO1-based ADCs.\n3. Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.\n4. Subjects who have received radiotherapy within 14 days , or chest radiotherapy \\> 30Gy within 6 months prior to the first dose of study drug.\n5. Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.\n6. Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.\n7. Subjects who have known or suspected interstitial pneumonitis.\n8. Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.\n9. Subjects who have any active, known or suspected autoimmune diseases.\n10. Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.\n11. Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.",{"count":241,"type":20},90,[79,23],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.",[26],"2024-11-15",{"date":247,"type":31},"2024-11-18",{"date":249,"type":31},"2024-11-04",{"date":251,"type":20},"2027-05-31",{"name":164,"class":93},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":260,"targetDuration":4,"studyType":262,"phases":4,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100562099","postoperative-adjuvant-immunotherapy-combined-with-radiotherapy-versus-surgery-alone-in-locally-advanced-utuc-100562099","NCT06598761","Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC","Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced Upper Tract Urothelial Carcinoma: a Prospective Observational Cohort Study","Inclusion Criteria:\n\n* 1\\) Patients after radical nephroureterectomy with full-length nephroureterectomy and pathologically confirmed cancer of the renal pelvis or ureter, AJCC staging (8th edition) containing one of the following factors: pT3-4, pN+; 2) Patients with creatinine eGFR \\\u003C60 min\u002FL. or underlying disease refusing to tolerate chemotherapy.\n\n3)18≤age≤80 years old; 4)Completion of abdominopelvic CT 4 weeks prior to enrolment. 5)Except for cutaneous non-melanoma and ductal carcinoma in situ of the breast, the patient has not suffered from any other malignant disease within the last 5 years; 6)Willing to participate in perfecting the necessary examinations and follow-up visits for the sake of the study, and willing to provide written informed consent.\n\nAll of the above need to be fulfilled:\n\nExpected survival \\> 6 months; KPS \\> 70 points; Leukocytes ≥ 3.5 x 109\u002Fl,Neutrophils ≥ 1.5 x 109\u002Fl, Platelets ≥ 100.0 x 109\u002Fl, Haemoglobin ≥ 90g\u002Fl.\n\nExclusion Criteria:\n\n* 1\\) Distant metastases already found at the time of surgery; non-R0 resected patients 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; (3) Pregnant or breastfeeding women; or women of childbearing potential who are not using reliable contraception; (4) History of malignant tumour (except skin cancer that is not malignant melanoma and cervical cancer in situ, tumours that have been cured for more than 5 years) 5) weight loss \\> 10% within 6 months 6) Presence of active infections in those with pre-existing or co-existing bleeding disorders 7) clinically significant cardiac disease (e.g., hypertension controlled by medication, unstable angina pectoris, New York Heart Association (NYHA) class ≥ II congestive heart failure, unstable symptomatic arrhythmia, or class ≥ II peripheral vascular disease); 8) Psychological, family, and social factors leading to lack of informed consent.",{"count":261,"type":20},60,"OBSERVATIONAL","This is a prospective cohort study to analyse the safety and efficacy of postoperative adjuvant radiotherapy combined with immunotherapy versus surgery alone group of UTUC patients with T3-4 stages or lymph nodes metastasis(N+) status.",[265,266,26],"Ureter Cancer","Renal Pelvic Carcinoma",[268,269,223,270,271],"upper tract urothelial carcinoma","Radiotherapy","Combined therapy","Prospective cohort study","2024-11-03",{"date":274,"type":31},"2024-11-05",{"date":276,"type":31},"2022-01-01",{"date":278,"type":20},"2027-08-30",{"name":280,"class":38},"Peking University First Hospital",2,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":128,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":120},"100522168","phase-1-9mw2821-combined-with-toripalimab-injection-in-subjects-with-local-advanced-or-metastatic-urothelial-cancer-100522168","NCT06079112","9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","A Phase Ib\u002FII, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","Inclusion Criteria:\n\n* Sign and date the informed consent form e approved by independent ethics committe.\n* Male or female subjects aged 18 to 80 years (including 18 and 80 years).\n* ECOG status of 0 or 1.\n* Histologically or cytologically confirmed local advanced or metastatic urothelial cancer\n* Subjects have received at least 1 line advanced standard therapy or were not treated before\n* Subjects must submit tumor tissues for test\n* Life expectancy of ≥ 12 weeks.\n* Subjects must have measurable lesions according to RECIST (version 1.1).\n* Adequate organ functions\n* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n* Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.\n* Major surgery within 28 days prior to first dose of study drug.\n* PD-1\u002FPD-L1\u002FPD-L2 inhibitors used in the previous treatment for La\u002Fm UC.\n* Previous treatment with ADCs conjugated with MMAE payload.\n* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.\n* Peripheral neuropathy Grade ≥ 2.\n* Poorly controlled blood sugar.\n* Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.\n* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n* Active infections, such as uncontrolled HBV\u002FHCV\u002FHIV\u002FTB infection, etc.\n* Other serious or uncontrolled diseases, such as serious interstitial pneumonia\u002Fasthma, serious thromboembolic events, etc.\n* Poorly controlled central nervous system metastases.\n* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* History of drug abuse or mental illness.\n* Known allergic sensitivity to any of the ingredients of the study drug.\n* Any P-glycoprotein (P-gp) inducers\u002Finhibitors or potent CYP3A4 inducers\u002Finhibitors within 14 days prior to the first dose of study drug.\n* History of autoimmune disease requiring systemic treatment within 2 years before the first dose.\n* Any live vaccines within 4 weeks before first dose of study drug or during the study.\n* Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.\n* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.\n* Other conditions unsuitable into the study.",{"count":130,"type":20},[79,23],"This is a phase Ib\u002FII, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.",[26],"2024-09-09",{"date":295,"type":31},"2024-09-19",{"date":297,"type":31},"2023-09-27",{"date":299,"type":20},"2027-12-31",{"name":208,"class":93},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":21,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":348,"leadSponsor":350,"locationsCount":120},"100495576","phase-2-cpi-613-devimistat-in-combination-with-hydroxychloroquine-and-5-fluorouracil-or-gemcitabine-in-treating-patients-with-advanced-chemorefractory-solid-tumors-100495576","NCT05733000","CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors","Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers","Inclusion Criteria:\n\n* Patients must have histologically confirmed cancer for which standard-of-care curative measures are no longer effective or be intolerant to those agents. Patients in cohort 1 must have colorectal cancer. Patients in cohort 2 must have pancreatic cancer. Patients in cohort 3 may have any of the following cancers:\n\n  * Biliary\n  * Gastroesophageal\n  * Urothelial\n  * Ovarian\n  * Non-small cell lung (adenocarcinoma only)\n* Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 disease.\n* Patients must have radiographic documentation of metastatic disease with imaging within =\\\u003C 6 weeks prior to registration.\n* Patients must be age \\>= 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Performance Status of 2 will be allowed with approval from principle investigator (PI) on a case-by case basis.\n\n  * Note: Performance status of 2 will be allowed with approval from PI on a case-by case basis. Documentation of PI approval in these cases will be stored with inclusion\u002Fexclusion signed checklist for patient and\u002For in patient's shadow chart.\n* Patients must have exhausted all available molecularly targeted therapies (e.g., anti-PD-1\u002Fanti-PD-L1 agents where indicated).\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (within the last 14 days of screening)\n* Hemoglobin (Hgb) \\>= 9 g\u002FdL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \\>= 7 days from transfusion).\n* Platelets (PLT) \\>= 100,000\u002FmcL (within the last 14 days of screening) (Transfusions permitted. Eligibility labs should be drawn \\>= 7 days from transfusion).\n* INR (international normalized ratio) =\\\u003C 1.6 (within the last 14 days of screening) (unless receiving anticoagulation therapy) If receiving anticoagulant: INR =\\\u003C 3.0 and no active bleeding, (i.e., no bleeding within 14 days prior to first dose of study therapy).\n* Total bilirubin =\\\u003C1.5 x Institutional upper limit of normal (ULN) (within the last 14 days of screening)\n\n  * Note: Patients with Gilbert's Syndrome are exempt. Patients with liver metastases with no significant bilirubin obstruction may have a total bilirubin level of =\\\u003C 2.0 mg\u002FdL.\n* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) =\\\u003C 2.5 x institutional ULN (within the last 14 days of screening)\n\n  * Note: If liver metastases are present, then =\\\u003C 5 x ULN is allowed.\n* Alanine transaminase (ALT) serum glutamic-pyruvic transaminase (SGPT) =\\\u003C 2.5 x institutional ULN (within the last 14 days of screening)\n\n  * Note: If liver metastases are present, then =\\\u003C 5 x ULN is allowed.\n* Serum albumin \\> 3.0 g\u002FdL (within the last 14 days of screening)\n* Creatinine =\\\u003C 1.5 x ULN OR glomerular filtration rate (GFR) \\>= 50 mL\u002Fmin\u002F1.73 m\\^2 (within the last 14 days of screening)\n\n  * eGFR is estimated GFR calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation\n* The effects of combination treatment of CPI-613, 5-FU, gemcitabine, and HCQ on the developing human fetus are unknown. For this reason and because antineoplastic agents as well as other therapeutic agents used in this trial are known to be teratogenic, patients of child-bearing potential (POCBP) regardless of gender must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 180 days following completion of therapy. Patients who can impregnate their partners regardless of gender must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 180 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n\n  * Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n  * Note: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative pregnancy test prior to registration on study.\n\n  * Note: If negative pregnancy test result is \\>7 days from first dose of study treatment it must be repeated at time of first dose of study treatment (with any of the four drugs used in this study).\n* For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.\n* For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment, must have an undetectable HCV viral load. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardio toxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Patients must be class 2B or better.\n\n  * Note: Patients with pacemakers where corrected QT interval (QTc) is not a reliable measure will require an evaluation by a cardiologist to exclude co-existing cardiac conditions which would prohibit safe participation in the study.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document for the duration of the entirety of the study.\n* Patients must be reliable, willing to make themselves available for the duration of the entire study and willing to follow screening procedures.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1).\n\n  * Note: Patients who experience adverse events of alopecia and peripheral neuropathy that have not recovered are eligible; patients with any lab abnormality that is above grade 1 related to previous therapy found to be not clinically significant will also be eligible.\n* Patients with symptomatic brain metastases currently using corticosteroids.\n\n  * Note: Patients with brain metastases who are asymptomatic and off corticosteroids for at least one week are eligible.\n* Patients with severe obstructive pulmonary disease or interstitial lung disease.\n* Patients with a history of myocardial infarction that is \\\u003C90 days prior to registration.\n* Patients using concomitant medications that prolong the QT\u002FQTc intervals. For example, patients receiving amiodarone. Using amiodarone together with hydroxychloroquine can increase the risk of long QT syndrome that although rare, may be serious, and potentially life-threatening.\n* Patients with a history of additional risk factors for drug-induced QT prolongation or Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT syndrome).\n* Patients with major surgery or significant traumatic injury =\\\u003C 21 days prior to registration.\n* Patients receiving treatment with low dose chemotherapy concurrent with radiation =\\\u003C 21 days prior to registration.\n\nOR patients who have had chemotherapy or radiotherapy =\\\u003C 21 days (42 days for nitrosoureas or mitomycin C) prior to registration.\n\n* Note: Palliative radiation before and during study participation is permissible providing it is not to a target lesion.\n\n  * Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\n* Ongoing or active infection requiring systemic treatment.\n* Clinically significant complications such as perforation, gastrointestinal bleeding, or diverticulitis within 42 days prior to registration.\n* Symptomatic congestive heart failure; symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction.\n* Unstable angina pectoris.\n* Unstable cardiac arrhythmia.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Active substance abuse.\n* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.\n\n  * Patients who are pregnant or nursing.\n  * Patients with Fridericia-corrected QT interval (QTcF) \\> 470 msec (female) or \\> 450 (male), or history of congenital long QT syndrome. Any electrocardiogram (ECG) abnormality that in the opinion of the investigator would preclude safe participation in the study.\n  * Patients who have pre-existing retinopathy of the eye.\n  * Patients who are unable to swallow or retain and absorb oral medication\n  * Patients with known hypersensitivity to any of the following: CPI or its inactive components, 4-aminoquinoline compounds, or quinine.\n  * Patients with poorly controlled diabetes mellitus (glycosylated hemoglobin (HbA1c) of \\> 7%, pre-prandial capillary plasma glucose \\> 130mg\u002Fdl, and peak postprandial capillary plasma glucose of \\> 180mg\u002Fdl).",{"count":309,"type":20},94,[23],"This phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.",[313,314,315,316,317,318,319,26,320,321,322,323,324,325,326,327,108,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343],"Advanced Biliary Tract Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Advanced Lung Adenocarcinoma","Advanced Malignant Solid Neoplasm","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Biliary Tract Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Lung Adenocarcinoma","Metastatic Ovarian Carcinoma","Metastatic Pancreatic Carcinoma","Refractory Biliary Tract Carcinoma","Refractory Colorectal Carcinoma","Refractory Gastroesophageal Junction Adenocarcinoma","Refractory Lung Adenocarcinoma","Refractory Ovarian Carcinoma","Refractory Pancreatic Carcinoma","Refractory Urothelial Carcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Colorectal Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","2023-03-08",{"date":346,"type":31},"2023-03-10",{"date":344,"type":31},{"date":349,"type":20},"2030-03-04",{"name":351,"class":38},"Northwestern University"]