[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urothelial-carcinoma-uc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urothelial-carcinoma-uc":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,53,83,135,167,194,215,237,268,298,319,347,380,410,440,463,495,517,537,562],{"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":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100640859","non-invasive-urinary-genomics-based-risk-assessment-for-early-urothelial-carcinoma-diagnosis-100640859",false,"NCT07614594","Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis","Non-invasive Urinary Genomics-Based Risk Assessment for Early Diagnosis of Urothelial Carcinoma","Inclusion Criteria:\n\nPatients are eligible if they meet all of the following criteria:\n\n1. Age ≥ 18 years.\n2. Presence of gross or microscopic hematuria.\n3. Imaging (B-ultrasonography, CT, or MRI) showing a renal pelvic, ureteral, or bladder lesion.\n4. Scheduled for surgery for tissue histopathological diagnosis.\n5. Able to provide written informed consent.\n\nExclusion Criteria\n\n1. Inadequate urine sample (poor quality or insufficient volume).\n2. Lack of final histopathological diagnosis.","ALL","18 Years",{"count":19,"type":20},800,"ESTIMATED","OBSERVATIONAL","This is a two-stage, prospective, single-center observational diagnostic accuracy study evaluating noninvasive urine testing for the detection of urothelial carcinoma (UC). The study enrolls adult patients presenting with gross or microscopic hematuria and imaging evidence of a space-occupying lesion in the renal pelvis, ureter, or bladder, who are scheduled for diagnostic cystoscopy and\u002For surgical tissue sampling. Histopathological examination serves as the reference standard.\n\nStage 1 (Completed, 8th October 2019 - 31st December 2023):\n\nA total of 113 participants have been enrolled. Owing to sufficient research funding, all participants in this stage underwent four urine-based tests: cytology, fluorescence in situ hybridization (FISH), DNA methylation, and a 17-gene mutation panel.\n\nStage 2 (Ongoing, from 1st January 2024):\n\nThe testing protocol was refined to focus on urine DNA methylation alone, owing to limited research funding and the lower cost of DNA methylation compared with the 17-gene mutation panel. As of registration (May 2026), approximately 330 participants have been enrolled.\n\nAll enrolled participants are categorized into two groups based on histopathology: a UC group (including upper tract urothelial carcinoma \\[UTUC\\] and bladder cancer \\[BC\\]) and a non-UC control group. The primary outcome is the diagnostic accuracy (area under the receiver operating characteristic curve \\[AUC\\] with 95% confidence interval, sensitivity, and specificity) of the four urine-based tests in the Stage 1 cohort. The key secondary outcome is the diagnostic accuracy of urine DNA methylation in the Stage 2 cohort. Other secondary outcomes include paired comparisons of AUCs among the four tests in the Stage 1 cohort. Exploratory analyses will include the diagnostic performance of urine cytology in a subset of Stage 2 participants with UTUC, as well as subgroup analyses by tumor site (UTUC vs. BC).\n\nBecause this study is purely observational and non-interventional, prospective registration was not a regulatory or institutional requirement when enrollment began in 2019. This record is being submitted prior to any data analysis to ensure consistency with current research transparency standards.",[24,25,26,27],"Urothelial Carcinoma (UC)","Upper Tract Urothelial Carcinoma","UTUC","Bladder Cancer (BC)",[29,30,31,32,33,34,35,36,37,38,39],"urothelial carcinoma","upper tract urothelial carcinoma","DNA methylation","17 genes mutation","diagnosis","bladder cancer","diagnostic efficacy","urine sample","cytology","fluorescence in situ hybridization","non-invasive detection","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":44},"2019-10-08",{"date":48,"type":20},"2030-12-31",{"name":50,"class":51},"Henan Provincial People's Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100644810","specimen-collection-for-validation-of-uroamp-a-next-generation-sequencing-platform-for-detection-and-surveillance-of-bladder-cancer-100644810","NCT07673016","Specimen Collection for Validation of UroAmp: A Next Generation Sequencing Platform for Detection and Surveillance of Bladder Cancer","INSITE","Inclusion Criteria:\n\nGROUP 1: Bladder Cancer and\u002For Upper Tract UCC\n\n* Male or female ≥ 18 years of age who are scheduled for transurethral resection of bladder tumor (TURBT) and\u002For biopsy of urinary tract or\n* Patients on surveillance who are negative for recurrence or tumor at the time of study enrollment but have had previous urothelial cell carcinoma (UCC) or\n* Patients with muscle invasive bladder cancer (MIBC) or non-muscle invasive bladder cancer (NMIBC) scheduled for NAC and\u002For subsequent radical cystectomy (RC)\n* Able to provide consent prior to diagnostic TURBT, nephroureterectomy, or administration of NAC and\u002For RC\n* Able to provide at least 20cc urine. If patient cannot void sufficient volume of urine, urologist can pull urine from the bladder via catheter or cystoscope. Urine should not be collected immediately after resection\n* Participation in other bladder cancer studies is allowed. Experimental therapy must be documented in the case report forms\n\nGROUP 2: Hematuria Controls\n\n* Male or female ≥ 18 years of age presenting with gross or microscopic hematuria as defined by standard of care\n* No evidence of and\u002For history of bladder cancer, upper tract UCC, kidney cancer and\u002For prostate cancer at the time of collection\n* Able to provide consent\n* Able to provide at least 20cc urine\n* Participation in other studies is allowed. Experimental therapy must be documented in the case report forms\n\nExclusion Criteria:\n\nGROUP 1: Bladder Cancer and\u002For Upper Tract UCC\n\n* Clinical, symptomatic urinary tract infection at time of initial urine collection\n* Unable to provide adequate urine sample\n\nGROUP 2: Hematuria Controls\n\n\\- Evidence and\u002For History of bladder cancer, upper tract UCC, kidney cancer and\u002For prostate cancer at the time of collection",{"count":61,"type":20},2500,"This is a prospective, multicenter observational study designed to collect urine and tumor biospecimens and associated clinical data from patients undergoing evaluation, treatment, or surveillance for urothelial carcinoma.",[64,24,65,66],"Bladder Cancer","Hematuria","Upper Tract Urothelial Cancer",[68,69,70,71],"Non-muscle invasive bladder cancer","Muscle invasive bladder cancer","Upper tract urothelial carcinoma","Urine tumor DNA","2026-06-24",{"date":74,"type":44},"2026-06-29",{"date":76,"type":44},"2019-10-15",{"date":78,"type":20},"2034-12",{"name":80,"class":81},"Convergent Genomics, Inc.","NETWORK",23,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":108,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270","NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease",{"count":91,"type":20},260,"INTERVENTIONAL",[94],"PHASE1","This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[97,98,99,100,101,24,64,102,103,104,105,106,107],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[109,110,111,112,113,114,115,116,117,118,119,120,121,122,123],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","2026-06-19",{"date":126,"type":44},"2026-06-23",{"date":128,"type":44},"2026-03-04",{"date":130,"type":20},"2028-04-30",{"name":132,"class":133},"IDEAYA Biosciences","INDUSTRY",14,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":92,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":144,"type":20},1314,[94],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[148,149,24,150,151,152,153,154,155,156],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Non-small Cell Lung Cancer (NSCLC)","Colorectal Cancer (CRC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)","2026-06-17",{"date":159,"type":44},"2026-06-22",{"date":161,"type":44},"2021-12-14",{"date":163,"type":20},"2030-06-28",{"name":165,"class":133},"Exelixis",122,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":92,"phases":175,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100643025","phase-2-neoadjuvant-enfortumab-vedotin-plus-pembrolizumab-in-muscle-invasive-bladder-cancer-and-upper-tract-urothelial-carcinoma-100643025","NCT07643519","Neoadjuvant Enfortumab Vedotin Plus Pembrolizumab in Muscle-Invasive Bladder Cancer and Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* Adults ≥ 18 years of age.\n* ECOG Performance Status of 0-2\n* For Cohort A, a clinical or pathological diagnosis consistent with muscle-invasive urothelial carcinoma of the bladder (locoregional), with a clinical staging of T2 or higher, N0 to N2, and M0.\n\nFor Cohort B, a clinical or pathological diagnosis of upper tract urothelial carcinoma, with high-intermediate risk or higher per NCCN guidelines, planned for definitive surgery.\n\n* High-intermediate: High grade + Unifocal \\\u003C1.5 cm\n* High: High grade + Multifocal or \\>1.5 cm or high-grade renal obstruction or invasion on axial imaging Any proportion of divergent differentiation is permitted across all histologies (except neuroendocrine - see exclusion criteria), as long as a urothelial component is identified.\n\n  * Eligible to receive enfortumab vedotin plus pembrolizumab (EV-P) in the opinion of the investigators.\n  * Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n  * Subjects must not have more than one active malignancy at the time of enrollment.\n\nNote: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen or primary endpoint (as determined by the treating physician) are eligible for this trial.\n\n\\- Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 months after the last dose of EV-P to minimize the risk of pregnancy. Prior to study enrollment, subjects of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.\n\nSOCBP includes any subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:\n\n* Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or\n* For subjects with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU\u002FmL.\n\n  * Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 4 months following the last dose of EV-P.\n\nExclusion Criteria:\n\n* Histology that contains any component of neuroendocrine carcinoma.\n* Any known contraindications to enfortumab vedotin plus pembrolizumab.\n* Subjects who are confirmed to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.",{"count":174,"type":20},39,[176],"PHASE2","Radical cystectomy remains the standard curative-intent treatment for most patients with muscle-invasive bladder cancer, but it is associated with significant morbidity and long-term quality-of-life implications. Trimodality therapy is an accepted standard-of-care alternative for carefully selected patients who wish to preserve their bladder; however, optimal patient selection remains challenging.\n\nThe combination of enfortumab vedotin plus pembrolizumab (EV-P) has demonstrated remarkable activity in urothelial carcinoma, including in the perioperative setting, with pathologic complete response rates of approximately 50-60%. These results generate the hypothesis that a subset of patients may achieve sufficiently deep responses to allow selective deferral of cystectomy. Cohort A of this trial prospectively evaluates the use of multimodal response assessment (pelvic MRI and TURBT, ctDNA) to guide individualized decisions regarding cystectomy versus bladder preservation.\n\nRadical nephroureterectomy (RNU) remains the standard curative-intent treatment for high-risk upper tract urothelial carcinoma (UTUC), but recurrence rates after surgery alone are high. Neoadjuvant cisplatin-based chemotherapy improves pathologic outcomes and is supported by phase II data, but its delivery is constrained by baseline renal dysfunction and the further decline in glomerular filtration that follows RNU - historically, only about 20% of patients remain cisplatin-eligible postoperatively, which is the principal rationale for delivering platinum in the neoadjuvant rather than adjuvant setting. A large fraction of patients with UTUC are cisplatin-ineligible at baseline, and no level 1 evidence supports a specific neoadjuvant regimen in this population.\n\nEV-P is not constrained by renal function and has produced unprecedented activity in urothelial carcinoma. In the EV-302 upper tract subgroup, EV-P achieved an objective response rate of 67.7% and a complete response rate of 28.6%, with survival benefit preserved relative to platinum-based chemotherapy. In the perioperative bladder cancer setting, EV-P has yielded pathologic complete response rates of approximately 50-60%. However, available data on EV-P in UTUC are restricted to the metastatic setting, and prospective evaluation in the neoadjuvant setting is lacking. Cohort B of this trial addresses this gap by prospectively evaluating neoadjuvant EV-P followed by RNU in patients with high-risk UTUC, with pathologic complete response as the primary endpoint.",[24],[34,180,181,182,183,29,30],"cystectomy","enfortumab vedotin","muscle invasive bladder cancer","pembrolizumab","NOT_YET_RECRUITING","2026-06-08",{"date":187,"type":44},"2026-06-11",{"date":189,"type":20},"2026-10",{"date":191,"type":20},"2030-10",{"name":193,"class":51},"University of Florida",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":92,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":52},"100643574","phase-2-a-phase-ii-study-of-ak146d1-mono-or-combined-with-ak112-in-advanced-urothelial-carcinoma-100643574","NCT07636772","A Phase II Study of AK146D1 Mono or Combined With AK112 in Advanced Urothelial Carcinoma","A Phase II Clinical Study to Evaluate the Safety，Tolerability，Pharmacokinetics and Anti-tumor Efficacy of AK146D1 Monotherapy or Combined With AK112 in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n* Be able to understand and voluntarily sign the written informed consent form.\n* Age 18-75.\n* ECOG PS 0 or 1.\n* Expected lifespan ≥3 months.\n* Histologically or cytologically documented Urothelial carcinoma.\n* At least one measurable lesion according to RECIST v1.1.\n* Sufficient organ function.\n\nExclusion Criteria:\n\n* Having other active malignancies within 3 years.\n* Currently participating in another interventional clinical study.\n* Presence of active metastases to the central nervous system.\n* Prior chemotherapy agent targeting topoisomerase I .\n* Receipt of systemic anti-tumor therapy within 4 weeks prior to the first dose.\n* Patients with clinically significant cardiovascular or cerebrovascular diseases or risks.\n* Patients with active autoimmune diseases requiring systemic treatment within 2 years.\n* Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose.\n* Previous history of severe hypersensitivity reactions.\n* Patients with a history of mental illness and incapacitated or limited capacity.\n* Any disease or condition that, in the opinion of the investigator, would compromise patient safety or interfere with study assessments.","75 Years",{"count":203,"type":20},132,[176],"This is a Phase II clinical study aimed at evaluating the safety, tolerability, antitumor efficacy, PK and immunogenicity of AK146D1 monotherapy or combined with AK112 in advanced Urothelial carcinoma.",[24],"2026-06-04",{"date":209,"type":44},"2026-06-09",{"date":159,"type":20},{"date":212,"type":20},"2028-08-24",{"name":214,"class":133},"Akeso",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":92,"phases":225,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100643694","study-of-peripheral-neuropathy-in-patients-with-advanced-urothelial-cancer-treated-with-enfortumab-vedotin-and-pembrolizumab-with-supportive-neuridase-endeavor-100643694","NCT07629700","Study of Peripheral Neuropathy in Patients With Advanced Urothelial Cancer Treated With Enfortumab Vedotin and Pembrolizumab With Supportive Neuridase (ENDEAVOR)","ENDEAVOR Study: A Prospective Exploratory Study Describing the Course of Peripheral Neuropathy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With Enfortumab Vedotin in Combination With Pembrolizumab and Supportive Neuridase","ENDEAVOR","IInclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed locally advanced or metastatic urothelial carcinoma\n* Candidate for treatment with enfortumab vedotin in combination with pembrolizumab according to clinical practice\n* Ability to provide written informed consent\n* Adequate clinical conditions to participate in the study according to investigator judgment\n\nExclusion Criteria:\n\n* Pre-existing severe peripheral neuropathy that may interfere with study assessments\n* Contraindications to enfortumab vedotin or pembrolizumab according to clinical practice\n* Known hypersensitivity to components of Neuridase\n* Pregnancy or breastfeeding\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, may interfere with study participation or interpretation of results",{"count":224,"type":20},40,[226],"NA","his prospective exploratory study aims to describe the course of peripheral neuropathy in patients with locally advanced or metastatic urothelial carcinoma treated with enfortumab vedotin in combination with pembrolizumab and receiving supportive Neuridase.\n\nPeripheral neuropathy is a common adverse event associated with enfortumab vedotin and may negatively affect treatment tolerability, quality of life, and treatment continuation. Neuridase is a non-pharmacological supportive product intended to support peripheral nervous system function; however, its role in this clinical setting has not yet been established.\n\nParticipants enrolled in this single-arm study will receive standard-of-care treatment with enfortumab vedotin plus pembrolizumab, together with supportive Neuridase according to clinical practice. The study will prospectively assess neuropathy symptoms and severity using clinical evaluations and patient-reported outcome measures, including quality-of-life questionnaires, over the course of treatment.\n\nThe objective of the study is to explore neuropathy patterns and treatment tolerability in this patient population.",[24,229],"Peripheral Nerve Disease",{"date":185,"type":44},{"date":232,"type":20},"2026-09-01",{"date":234,"type":20},"2028-09-01",{"name":236,"class":51},"University of Florence",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":92,"phases":245,"briefSummary":246,"conditions":247,"keywords":257,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":4},"100643560","phase-2-an-exploratory-study-of-zanidatamab-in-her2-positive-advanced-tumor-after-at-least-one-line-of-standard-therapy-100643560","NCT07631871","An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years old.\n2. Subjects with locally advanced, unresectable or metastatic solid tumors who have progressed after ≥1 prior systemic therapy for advanced\u002Fmetastatic disease, or have no available optimal alternative treatments. Qualified tumor types include but are not limited to endometrial carcinoma, urothelial carcinoma, pancreatic cancer, colorectal carcinoma (CRC), head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary of the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Biliary tract malignancy, lung cancer and breast cancer are excluded. For CRC patients: documented RAS status (wild-type or mutant) and wild-type BRAF; prior treatment regimen should contain fluoropyrimidine, oxaliplatin and irinotecan unless contraindicated; anti-VEGF therapy when clinically indicated; anti-PD-L1 therapy for MSI-H\u002FdMMR tumors if clinically indicated.\n3. ECOG Performance Status 0, 1 or 2.\n4. Confirmed HER2 positivity defined as IHC 3+, or IHC 2+ with positive FISH amplification (per GC criteria).\n5. Willing and capable of providing adequate tumor specimens for central pathological re-assessment of HER2 status at institutional pathology department. Patients previously treated with HER2-ADC must provide FFPE tumor samples collected after last HER2-ADC administration. Specimens with insufficient tumor cellularity and fine-needle aspiration samples are not acceptable for HER2 testing.\n6. At least one measurable lesion at baseline per RECIST 1.1 criteria.\n7. Adequate bone marrow and organ function confirmed within 14 days prior to enrollment: Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 75,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1000\u002Fmm³; Serum albumin ≥ 2.5 g\u002FdL; PT, aPTT and INR ≤ 1.5 × ULN; AST\u002FALT ≤ 3 × ULN; ≤5 × ULN for subjects with liver metastasis; Total bilirubin ≤1.5 × ULN (no liver metastasis); ≤3 × ULN (baseline Gilbert syndrome or liver metastasis); Creatinine clearance ≥30 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. LVEF ≥50% evaluated via echocardiogram (ECHO) or MUGA scan within 28 days before enrollment.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible:\n\n1. Documented spinal cord compression, leptomeningeal disease or clinically active central nervous system (CNS) metastasis.\n2. Active primary immunodeficiency, confirmed HIV infection, active HBV or HCV infection.\n3. History of non-infectious interstitial lung disease (ILD)\u002Fnon-infectious pneumonia requiring steroid therapy, ongoing active ILD\u002Fnon-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by screening imaging.\n4. History of myocardial infarction, symptomatic congestive heart failure (CHF, NYHA Class II-IV), unstable angina, or any cardiovascular event (including stroke) within 6 months prior to enrollment.\n5. Pulmonary exclusion items: (a) Clinically significant underlying pulmonary disorders, including but not limited to pulmonary embolism within 3 months before screening, severe asthma, severe COPD, restrictive lung disease, recurrent pleural effusion; (b) Confirmed autoimmune, connective tissue or inflammatory diseases (rheumatoid arthritis, Sjögren's syndrome, sarcoidosis etc.), or suspected pulmonary involvement at screening; full disease details shall be recorded in eCRF for enrolled subjects; (c) Previous total pneumonectomy.\n6. Confirmed presence of HER2 gene mutation.",{"count":244,"type":20},10,[176],"The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced solid tumors? Participants will receive Zanidatamab intravenously on Day 1 of each 2-week treatment cycle. The dosage is 20 mg\u002Fkg per cycle.",[248,249,250,251,24,252,253,254,255,256],"Neoplasms","Solid Tumors","HER2 Positive Solid Tumor","Endometrial Neoplasm","Pancreatic Neoplasms","Colorectal Neoplasms","Head and Neck Neoplasms","Cervical Neoplasms","Ovarian Neoplasms",[250,258,259],"Zanidatamab","Basket Study","2026-06-02",{"date":185,"type":44},{"date":263,"type":20},"2026-06-15",{"date":265,"type":20},"2029-12-31",{"name":267,"class":51},"Haihua Yuan",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":92,"phases":276,"briefSummary":277,"conditions":278,"keywords":289,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":295,"leadSponsor":297,"locationsCount":4},"100643697","phase-2-exploratory-study-on-the-efficacy-and-safety-of-trastuzumab-rezetecan-in-the-treatment-of-her2-expressiong-advanced-solid-tumor-100643697","NCT07631884","Exploratory Study on the Efficacy and Safety of Trastuzumab Rezetecan in the Treatment of HER2-Expressiong Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male and female participants aged 18 years or older.\n2. Participants with locally advanced, unresectable or metastatic solid tumors who have progressed after at least one prior systemic therapy for advanced\u002Fmetastatic disease, or have no satisfactory alternative treatment options. Eligible tumor types include but are not limited to biliary tract cancer, endometrial cancer, urothelial carcinoma, pancreatic cancer, colorectal cancer, gastric cancer, non-small cell lung cancer, head and neck adenocarcinoma (salivary gland adenocarcinoma, lacrimal gland adenocarcinoma, adenocarcinoma of unknown primary in the neck), cervical cancer, ovarian cancer and adenocarcinoma of unknown primary. Breast cancer is excluded.\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n4. Confirmed HER2 expression defined as IHC 1+, 2+ or 3+ (per GC criteria).\n5. Willing and able to provide adequate tumor specimens for central pathological re-testing of HER2 status. For participants previously treated with anti-HER2 therapy, tumor specimens obtained after the last anti-HER2 treatment are optional.\n6. At least one measurable lesion at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Adequate organ and bone marrow function within 14 days prior to enrollment, meeting the following criteria:\n\n   Hemoglobin ≥ 9 g\u002FdL; Platelet count ≥ 100,000\u002Fmm³; Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³; Serum albumin ≥ 3.0 g\u002FdL; Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International Normalized Ratio (INR) ≤ 1.5 × upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN; ≤ 5 × ULN for participants with liver metastases; Total bilirubin ≤ 1.5 × ULN for participants without liver metastases; ≤ 3 × ULN for participants with Gilbert's syndrome or liver metastases at baseline; Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula)\n8. Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days prior to enrollment.\n\nExclusion Criteria:\n\nParticipants meeting any of the following conditions are ineligible for this study:\n\n1. Presence of any severe and\u002For uncontrolled diseases:\n\n   * Poorly controlled blood pressure (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); poorly controlled diabetes (fasting blood glucose \\[FBG\\] \\> 10 mmol\u002FL).\n   * Grade ≥ 2 myocardial ischemia, myocardial infarction, arrhythmia (QTc interval ≥ 470 ms), or Grade ≥ 2 congestive heart failure (per New York Heart Association \\[NYHA\\] classification).\n   * Active or uncontrolled severe infections (Grade ≥ 2 per NCI CTCAE) requiring systemic antibacterial, antifungal or antiviral therapy, including pulmonary tuberculosis.\n   * History of active tuberculosis.\n   * Uncontrolled ascites, pericardial effusion or pleural effusion requiring repeated drainage.\n2. Active hepatitis: Liver function not meeting the inclusion criteria. Hepatitis B: HBV DNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL.Hepatitis C: HCV RNA ≥ 2000 IU\u002FmL or ≥ 10\\^4 copies\u002FmL. Participants with viral load below the above thresholds after nucleoside antiviral therapy are eligible. Chronic hepatitis B virus carriers with HBV DNA \\\u003C 10\\^4 IU\u002FmL must receive concurrent antiviral treatment throughout the study for enrollment.\n3. History of immunodeficiency diseases, including HIV positivity or other acquired\u002Fcongenital immunodeficiency disorders.\n4. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n5. Confirmed meningeal metastasis, spinal cord metastasis or spinal cord compression.\n6. Within 6 months prior to the first study drug administration, presence of esophageal gastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, acute gastrointestinal bleeding, extensive intestinal resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.\n7. Unhealed or poorly healing wounds, or active ulcers.\n8. Toxicities from prior anti-tumor therapy have not resolved to Grade 0 or 1 per NCI CTCAE version 5.0.\n9. Received major surgery, incisional biopsy or significant traumatic injury within 28 days before study treatment initiation; or with long-standing unhealed wounds or fractures.\n10. History of severe hypersensitivity reactions to monoclonal antibodies; known allergy to the active ingredients or excipients of the study drug.",{"count":275,"type":20},15,[176],"The goal of this clinical trial is to learn if Trastuzumab Rezetecan can treat advanced solid tumors with HER-2 expression in adult participants.\n\nThe main question it aims to answer is: What is the objective response rate of Trastuzumab Rezetecan in adult patients with HER-2 expressed advanced solid tumors? Participants will receive intravenous infusion of Trastuzumab Rezetecan on Day 1 of each 21-day treatment cycle. The dosage is 4.8 mg\u002Fkg per cycle; participants with a body weight of 85 kg or above will receive a fixed dose of 408 mg every 3 weeks.",[249,279,280,281,282,283,284,285,286,24,252,253,287,288,254,255],"Neoplasms (Cancer \u002F Tumors)","Advanced Malignant Solid Neoplasm","Locally Advanced Malignant Solid Neoplasm","Unresectable Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","HER2 Expression","Biliary Tract Neoplasms","Endometrial Neoplasms","Gastric Neoplasms","Non-Small Cell Lung Carcinoma (NSCLC)",[290,291,292],"HER2 expression","Trastuzumab Rezetecan","Advanced Solid Tumor",{"date":185,"type":44},{"date":263,"type":20},{"date":296,"type":20},"2028-12-31",{"name":267,"class":51},{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":92,"phases":306,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":52},"100626706","early-phase-1-safety-and-tolerability-study-of-68ga177lu-brp-020063-in-advanced-solid-tumors-100626706","NCT07439120","Safety and Tolerability Study of 68Ga\u002F177Lu-BRP-020063 in Advanced Solid Tumors","A Study Evaluating the Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga\u002F177Lu-BRP-020063 in Patients With Advanced Metastatic Solid Tumors.","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender;\n2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);\n3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);\n4. Performance status (ECOG) score of 0-1;\n5. Adequate organ function:\n\n   * Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹\u002FL, neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL, platelet count ≥ 75 × 10⁹\u002FL;\n   * Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN;\n   * Renal function: Creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula);\n   * Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN;\n6. Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females);\n7. Willing to participate in this trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Previous treatment with Nectin-4-targeted drugs (including clinical trials);\n2. Inability to complete PET\u002FCT or SPECT\u002FCT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);\n3. Participation in drug or device clinical studies within 4 weeks prior to the first dose;\n4. Presence of severe or uncontrolled underlying diseases, including but not limited to:\n\n   1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;\n   2. Severe cardiovascular\u002Fcerebrovascular or valvular diseases;\n   3. Poorly controlled diabetes or hypertension;\n5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);\n6. Active infection within 4 weeks prior to the first dose;\n7. Women who are planning pregnancy, currently pregnant, or breastfeeding;\n8. Allergy to radioactive rays or other severe allergic history;\n9. History of neurological metastasis with associated symptoms;\n10. Concurrent other malignancies;\n11. Undergone general anesthesia surgery within 4 weeks prior to the first dose;\n12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.",{"count":244,"type":20},[307],"EARLY_PHASE1","This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga\u002F¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET\u002FCT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.",[24],"2026-06-01",{"date":312,"type":44},"2026-06-03",{"date":314,"type":44},"2026-04-13",{"date":316,"type":20},"2026-08-31",{"name":318,"class":51},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":328,"conditions":329,"keywords":332,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":52},"100637474","comparison-of-ct-and-mr-vi-rads-imaging-for-local-bladder-cancer-staging-100637474","NCT07602010","Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging","Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Newly diagnosed bladder cancer on cystoscopy\n* Planned TURBT or cystectomy within 6 weeks\n* Eligible for both CT and MRI within 6 weeks\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Contraindications to MRI or iodinated contrast media\n* Prior treatment for bladder cancer\n* Pregnancy\n* Non-malignant bladder lesions\n* Tumors located in bladder diverticula",{"count":327,"type":20},150,"This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.",[64,24,330,331],"Muscle Invasive Bladder Cancer (MIBC)","Non Muscle Invasive Bladder Cancer",[333,334,335,336,337],"MRI","Computed Tomography","VI-RADS","Local Staging","Diagnostic Accuracy","2026-05-15",{"date":340,"type":44},"2026-05-22",{"date":342,"type":44},"2026-04-22",{"date":344,"type":20},"2028-10-31",{"name":346,"class":51},"Oslo University Hospital",{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":354,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":92,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":52},"100635787","18f-t2-petct-imaging-for-caix-positive-solid-tumors-100635787","NCT07557225","18F-T2 PET\u002FCT Imaging for CAIX Positive Solid Tumors","Evaluation of Diagnostic Value of 18F-T2 PET\u002F CT Imaging for Tumors Likely to Express High Levels of CAIX","Inclusion Criteria:\n\nAll participants must meet the following criteria:\n\n1. Written and voluntarily given Informed Consent.\n2. Male or female ≥18 years of age at time of consent.\n3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.\n4. Participants with histologically confirmed or suspected tumors of the following types, but not limited to:\n\nClear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.\n\nExclusion Criteria:\n\nParticipants will be excluded from participation in the study if one or more of the following criteria are met:\n\n1. Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.\n2. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.\n3. Be a female who is pregnant or breastfeeding.",true,{"count":356,"type":20},200,[226],"The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET\u002FCT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.",[360,24,361,362,363,364,151,365,366,367,368,106,369,370],"Clear Cell Renal Cell Cancer (ccRCC)","Colorectal Cancer","Cervical Cancer","Ovarian Cancer","Head and Neck Cancer","Cholangiocarcinoma","Non Small Cell Lung Cancer","Small Cell Lung Cancer","Breast Cancer","Endometrial Cancer","Von Hippel Lindau Disease","2026-05-12",{"date":373,"type":44},"2026-05-14",{"date":375,"type":44},"2026-04-27",{"date":377,"type":20},"2029-03",{"name":379,"class":51},"Peking University First Hospital",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":92,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":52},"100624737","randomized-trial-of-standard-of-care-with-or-without-metastases-directed-stereotactic-body-radiation-therapy-in-patients-affected-by-oligometastatic-urothelial-carcinoma-100624737","NCT07413523","Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA","Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA: ASTRA Trial","ASTRA","Inclusion Criteria:\n\n* Age \\> 18 years\n* WHO performance status ≤ 2\n* Pathological proven urothelial carcinoma\n* Stage IV disease at imaging\n* Maximum of 3 extracranial metastases\n* Indication to receive I or II line of standard systemic therapy\n* Adequate liver function\n* Adequate bone marrow function\n* Written informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Previous radiation therapy on the same target lesions\n* Pregnant or breastfeeding patients\n* Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)\n* Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study\n* WHO PS \\>=3",{"count":389,"type":20},44,[226],"Bladder cancer is the most common type of urothelial cancer. When the disease has spread to other parts of the body (metastatic disease), the prognosis is often poor, because there are only a few effective treatment options available.\n\nAt the moment, standard treatment mainly includes systemic therapies, such as chemotherapy and immunotherapy (immune checkpoint inhibitors). These treatments act on the whole body. However, the use of local treatments, such as stereotactic radiotherapy, has not been well studied in bladder cancer.\n\nStereotactic radiotherapy is a type of radiation treatment that delivers very high doses of radiation to the tumor in a small number of treatment sessions. This technique is already widely used to treat a limited number of metastases (called oligometastases) from other types of cancer.\n\nThe aim of this study is to understand whether stereotactic radiotherapy is also effective and safe for treating oligometastases coming from bladder cancer.",[64,24,393],"Oligometastasis",[395,396,397,398,399,400],"SBRT","SYSTEMIC TREATMENT","UROTHELIAL CARCINOMA","BLADDER CANCER","OLIGOMETASTASIS","RADIOTHERAPY","2026-04-24",{"date":403,"type":44},"2026-04-30",{"date":405,"type":44},"2026-02-16",{"date":407,"type":20},"2030-02",{"name":409,"class":51},"Istituto Clinico Humanitas",{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":92,"phases":419,"briefSummary":420,"conditions":421,"keywords":425,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":4},"100635675","phase-1-calcium-electroporation-for-urinary-bladder-tumors-a-first-in-human-feasibility-safety-and-early-response-trial-100635675","NCT07555769","Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial","Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial","CALCIFER","Inclusion Criteria:\n\n* Age ≥ 18 years and able to understand participant information and give informed consent\n* Histologically verified urothelial bladder tumor\n* Unfit for cystectomy and\u002For radiotherapy\n* Patients with recurrence after radiotherapy unfit for salvage cystectomy\n* Disease where other treatments are considered unsuitable or have been declined by the patient\n* The patient may receive simultaneous systemic treatment\n* Selected high-burden non-muscle-invasive bladder tumors after MDT assessment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n* Life expectancy of ≥ 3 months\n* Patients must be deemed able to tolerate general anesthesia\n* Sexually active participants in the reproductive age must use contraception. Accepted contraception includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization\n* Patients must stop treatment with anticoagulants before surgery in accordance with national guidelines\n* Plasma ionized Ca2+ must be within the normal upper limit. Correction is allowed\n* Hematology\n\n  * Thrombocytes ≥ 50 billion\u002FL\n  * International normalized ratio (INR) ≤ 1.5. Correction is allowed\n\nExclusion Criteria:\n\n* Pregnancy (confirmed by a blood sample) or lactation\n* Allergy to calcium gluconate or any of its excipients\n* Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible\n* Contraindications to treatment with calcium gluconate as described:\n\n  * Hypersensitivity to calcium gluconate or any of its excipients\n  * Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)",{"count":5,"type":20},[94],"This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in patients with limited alternative therapies. The anticipated benefits and structured safety precautions justify the ethical conduct of the investigation.",[422,423,24,424],"Bladder Tumors","Bladder Tumor","Urothelial Carcinoma Bladder",[426,427,428,429,430],"calcium electroporation","electroporation","transurethral electroporation","bladder tumors","urothelial tumor","2026-04-21",{"date":433,"type":44},"2026-04-29",{"date":435,"type":20},"2026-06",{"date":437,"type":20},"2030-04",{"name":439,"class":51},"Juan Luis Vásquez",{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":92,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":459,"leadSponsor":461,"locationsCount":4},"100632773","phase-1-a-study-of-hlx18-vs-opdivo-in-multiple-resected-solid-tumors-100632773","NCT07518043","A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetic Profile, Efficacy, Safety and Immunogenicity of HLX18 vs. OPDIVO® (US-sourced OPDIVO®) in Multiple Resected Solid Tumors","Inclusion Criteria:\n\n1. Participants must have signed and dated an IRB\u002FIEC approved written informed consent form.\n2. Aged 18 to 70 years at the time of signing the ICF.\n3. 18 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm² and 50 kg ≤ body weight ≤ 85 kg.\n4. Histologically confirmed solid tumors (EC\u002FGEJC, Melanoma, or UC) status post R0 resection.\n5. For EC\u002FGEJC: residual pathologic disease (non-pCR) following neoadjuvant chemoradiotherapy and R0 resection.\n6. For Melanoma: Stage IIB-IV after complete surgical resection with documented negative margins.\n7. For UC: High-risk muscle-invasive urothelial carcinoma (MIUC) following radical resection (R0).\n8. Documented disease-free status (no recurrence) by imaging and physical exam within 4 weeks prior to randomization.\n9. Adequate recovery from prior surgery or systemic therapy.\n10. ECOG Performance Status of 0.\n11. Adequate organ function.\n12. Agreement to use effective contraception (negative pregnancy test for WOCBP).\n\nExclusion Criteria:\n\n1. History of illicit drug use or alcohol abuse within 12 months prior to randomization.\n2. Tumor-specific exclusions: cervical esophageal cancer, Stage IV EC\u002FGEJC, or ocular melanoma.\n3. UC-specific surgical exclusions: status post partial cystectomy or partial nephrectomy.\n4. EC\u002FGEJC treatment violations: failure to receive mandatory preoperative concurrent CRT (mono-therapy is ineligible).\n5. Prior treatment with nivolumab or any other immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4).\n6. Other primary active malignancies within 5 years or history of organ\u002Fbone marrow transplantation.\n7. Significant cardiovascular disease (MI, cerebrovascular disease) or unstable arrhythmia (QTc \\> 450ms\u002F470ms) within 6 months.\n8. Chronic heart failure (NYHA Class III-IV) or LVEF \\\u003C 50% at screening.\n9. Presence of interstitial pneumonia, pneumonitis, or severe lung function abnormalities.\n10. Active autoimmune disease requiring systemic immunosuppressive therapy.\n11. Known HIV infection, active Hepatitis B\u002FC, or active pulmonary tuberculosis.\n12. Peripheral neuropathy ≥ Grade 2 or history of carcinomatosis meningitis.\n13. Use of systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent), immunosuppressants, or live vaccines within 28 days.\n14. Recent or planned participation in other investigational drug, device, or surgical studies.\n15. Severe allergic reactions to monoclonal antibodies or any condition deemed unsuitable by the investigator.\n16. The investigator has a clear reason to believe that participation in this study would be detrimental to the participant.","70 Years",{"count":449,"type":20},174,[94],"This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC\u002FGEJC), melanoma (MEL), or urothelial carcinoma (UC).",[453,454,24],"Esophageal and\u002For Cardia Cancer","Melanoma","2026-04-12",{"date":457,"type":44},"2026-04-15",{"date":41,"type":20},{"date":460,"type":20},"2028-06-13",{"name":462,"class":133},"Shanghai Henlius Biotech",{"id":464,"slug":465,"hasResults":11,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":472,"conditions":473,"keywords":477,"overallStatus":184,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":4},"100633335","immune-stromal-landscape-in-muscle-invasive-bladder-cancer-100633335","NCT07525349","Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer","The Immune-Stromal Landscape of Muscle-Invasive Urothelial Bladder Carcinoma: A Morphological Histopathological Study","Inclusion Criteria:\n\n* Patients who underwent radical cystectomy for muscle invasive urothelial carcinoma.\n* Treated at the South Egypt Cancer Institute (SECI) between 2018 and 2024.\n\nExclusion Criteria:\n\n* Cases with non-urothelial histological subtypes (e.g., pure squamous cell carcinoma).\n* Patients who received neoadjuvant chemotherapy or radiotherapy.\n* Cases with missing or inaccessible clinical follow-up data.\n* History of prior or concurrent malignancy.",{"count":471,"type":20},100,"Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy). However, even after surgery, it can be difficult for doctors to accurately predict how an individual patient's disease will progress using standard staging methods.\n\nThis retrospective observational study aims to find better ways to predict patient outcomes by examining the tumor microenvironment, which is the environment immediately surrounding the cancer cells. Specifically, researchers are looking at the relationship between the tumor cells, the surrounding supportive tissue (the stroma), and the patient's natural immune cells.\n\nThe study will review existing medical records and archived tumor tissue samples from at least 100 patients who underwent radical cystectomy at the South Egypt Cancer Institute between 2018 and 2024. Under a microscope, researchers will assess three main features:\n\n* Tumor-Stroma Ratio (TSR): The amount of tumor tissue compared to the surrounding supportive tissue.\n* Tumor-Infiltrating Lymphocytes (TILs): The number of immune cells that have moved into the tumor to try and fight it.\n* Tertiary Lymphoid Structures (TLS): Organized clusters of immune cells that form near the tumor.\n\nBy analyzing these features, the researchers hope to determine if specific patterns of immune and supportive cells are linked to better or worse survival rates, such as Overall Survival and Disease-Free Survival. Understanding this immune-stromal landscape could lead to more personalized risk assessments and better treatment plans for future bladder cancer patients.",[474,24,64,475,476],"Muscle-Invasive Bladder Carcinoma","Muscle-Invasive Urothelial Bladder Carcinoma","Urinary Bladder Neoplasms",[478,479,480,481,482,483,484,485,486],"Muscle-Invasive Bladder Cancer (MIBC)","Urothelial Carcinoma","Radical Cystectomy","Tumor Microenvironment","Tumor-Stroma Ratio (TSR)","Tumor-Infiltrating Lymphocytes (TILs)","Tertiary Lymphoid Structures (TLS)","Glasgow Microenvironment Score (GMS)","Klintrup-Mäkinen (KM) Score","2026-04-07",{"date":314,"type":44},{"date":490,"type":20},"2026-05",{"date":492,"type":20},"2027-06",{"name":494,"class":51},"Assiut University",{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":16,"minAge":502,"maxAge":4,"enrollmentInfo":503,"targetDuration":505,"studyType":21,"phases":4,"briefSummary":506,"conditions":507,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":52},"100627730","korean-prospective-upper-tract-urothelial-carcinoma-cohort-100627730","NCT07452432","Korean Prospective Upper Tract Urothelial Carcinoma Cohort","Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n* Age ≥ 19 years\n\nHistologically confirmed high-grade upper tract urothelial carcinoma (renal pelvis and\u002For ureter)\n\nClinical stage cT2-T4, cN0-1, M0\n\nPlanned neoadjuvant chemotherapy followed by radical nephroureterectomy\n\nECOG performance status 0-1\n\nAdequate hematologic, hepatic, and renal function\n\nAbility to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence of distant metastasis (M1)\n\nContraindication to cisplatin-based chemotherapy\n\nUncontrolled infection or severe comorbid medical condition\n\nPregnancy or breastfeeding\n\nAny condition that, in the investigator's judgment, makes participation inappropriate","19 Years",{"count":504,"type":20},300,"5 Years","This is a single-center, prospective, non-interventional observational cohort study designed to establish a structured recurrence monitoring platform in Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (UTUC).\n\nEligible adult patients scheduled to receive neoadjuvant chemotherapy followed by radical nephroureterectomy will undergo circulating tumor DNA (ctDNA) sampling prior to chemotherapy initiation and once between 1-6 months after surgery.\n\nClinical, imaging, pathological, and longitudinal follow-up data will be prospectively collected to enable long-term monitoring of recurrence and survival outcomes.\n\nThe primary objective is to establish a prospective cohort integrating clinical and molecular data to support future translational research and recurrence prediction modeling in UTUC.",[24],"2026-02-28",{"date":510,"type":44},"2026-03-05",{"date":512,"type":44},"2026-01-01",{"date":514,"type":20},"2030-06-01",{"name":516,"class":51},"Samsung Medical Center",{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":52},"100626889","using-liquid-biopsy-testing-to-identify-monitor-predict-recurrence-in-urothelial-carcinoma-100626889","NCT07441499","Using Liquid Biopsy Testing to Identify, Monitor, Predict Recurrence in Urothelial Carcinoma","Inclusion Criteria:\n\n* Suspected or histologically confirmed urothelial carcinoma\n\nExclusion Criteria:\n\n* History of or concurrent active malignancy other than urothelial carcinoma",{"count":504,"type":20},"Application of Multi-Component Liquid Biopsy (ctDNA, utDNA, Exosomes, and Protein Biomarkers in Blood and Urine) for Auxiliary Diagnosis, Therapeutic Response Evaluation, and Recurrence Monitoring in Urothelial Carcinoma",[24,526,527],"Bladder (Urothelial, Transitional Cell) Cancer","Liquid Biopsy","2026-02-27",{"date":530,"type":44},"2026-03-02",{"date":532,"type":20},"2026-03",{"date":534,"type":20},"2029-01-01",{"name":536,"class":51},"Tianjin Medical University Second Hospital",{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":92,"phases":546,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":560,"locationsCount":244},"100493513","phase-1-a-study-to-assess-safety-tolerability-and-imaging-characteristics-of-68gaga-dpi-4452-and-to-assess-safety-tolerability-and-efficacy-of-177lulu-dpi-4452-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100493513","NCT05706129","A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-Label, Non-Randomized Phase 1\u002F2 Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Written informed consent, dated and signed by the patient prior to any study-specific procedure.\n* Part B and C are not conducted in the United States of America.\n* Has histologically or cytologically confirmed, unresectable locally advanced or metastatic solid tumors of:\n* Clear cell renal cell cancer (ccRCC) - participants must have received at least one line containing Tyrosine kinase inhibitor (TKI) treatment and at least one line containing immune checkpoint inhibitor treatment in metastatic setting, meaning at least two lines of treatment in metastatic setting.\n* Pancreatic ductal adenocarcinoma (PDAC) - participants must have received at least one line of platinum- and\u002For gemcitabine-based regimen.\n* Colorectal cancer (CRC) - participants must have received at least one line of FOLFIRINOX or FOLFOX\u002FFOLFIRI in two lines in combination with anti-Vascular Endothelial Growth Factor (VEGF) or anti-Epidermal Growth Factor Receptor (EGFR).\n* Participants with CRC or PDAC: availability of fresh biopsy, OR an archival biopsy\u002Fsurgical specimen of the tumor (preferably, taken after last prior line of therapy).\n* For Part B and C only: Urothelial cancer (UC) patients must have received all available standard of care if eligible, including one line of platinum-based chemotherapy, enfortumab vedotin and pembrolizumab.\n* Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography \u002F magnetic resonance imaging (CT\u002FMRI)) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration.\n* Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nPart D:\n\nParticipants with imaging evidence of a single indeterminate renal mass (IDRM) of ≤ 7 cm in largest diameter (tumor stage cT1) on any conventional diagnostic imaging technique, suspicious for ccRCC and planned for total or partial nephrectomy, or interventional diagnostic (cystoscopy and retrograde pyelography or biopsy) within 90 days from planned \\[68Ga\\]Ga-DPI-4452 administration.\n\nPart E:\n\nRegardless of lines of treatment, participants with histologically or cytologically confirmed progressive, unresectable locally advanced or metastatic solid tumors of\n\n* UC, including MIBC\n* H\\&N cancer\n* TNBC\n* Squamous NSCLC\n* Any other indication with confirmed carbonic anhydrase IX (CA IX) expression excluding ccRCC, PDAC and CRC, upon Sponsor agreement.\n\nPresence of at least 1 non-irradiated tumor lesion detected at conventional imaging (CT\u002FMRI) documented within 4 weeks prior to the \\[68Ga\\]Ga-DPI-4452 administration (for scans dated more than 4 weeks prior to D1, the Sponsor should be contacted to assess conventional imaging suitability)\n\nExclusion Criteria:\n\n* Any major surgery within 12 weeks before enrolment.\n* Inability to stay in the scanner bed with the arms resting out of the thoracic and abdominal fields (i.e., arms alongside the body or raised arm position) for the duration of the scan.\n\nPart A:\n\n* Has known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, and\u002For stable Grade 2 sensory neuropathy, according to National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\]).\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Previous Carbonic anhydrase (CA) IX-targeting treatment.\n* Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow, as judged by the Investigator.\n\nPart B and Part C:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Bladder outflow obstruction or unmanageable urinary incontinence.\n* Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, active clinically significant cardiac disease, or radiotherapy to Grade ≤1 (except for laboratory parameters specified above, Grade 2 alopecia, or stable Grade 2 sensory neuropathy, according to NCI-CTCAE).\n* Administration of a radiopharmaceutical with therapeutic intent within a period of 6 months prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment for non-oncological indication within 3 months prior to the \\[177Lu\\]Lu-DPI-4452 infusion; any previous CA IX-targeting treatment for any oncological indication.\n* Participants who received any systemic antineoplastic therapy for the underlying disease and\u002For other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).\n* Inflammatory bowel disease (e.g Crohn's disease, ulcerative colitis, etc).\n\nPart D:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Any previous CA IX-targeting treatment within 3 months prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n* Ongoing treatment with sulfonamides and\u002For coumarin derivatives (e.g., acenocoumarol, warfarin, phenprocoumon) within 2 weeks (or 5 half-lives, whichever is longer) prior to the \\[68Ga\\]Ga-DPI-4452 injection.\n\nPart E:\n\n* Known hypersensitivity to the active substance, to any of the excipients of the DPI-4452, or to radiographic contrast agents.\n* Administration of a radiopharmaceutical within a period corresponding to 10 half-lives of the radionuclide used prior to injection of \\[68Ga\\]Ga-DPI-4452.\n* Any previous CA IX-targeting treatment within 3 months prior to \\[68Ga\\]Ga-DPI-4452 injection.\n* EBRT to more than 25% of the bone marrow, as judged by the Investigator.\n* Malignant disease, other than that being treated in this study. Exceptions include the following: malignancies that were treated curatively and have not recurred within 2 years prior to screening; treated basal cell or localized squamous skin carcinomas, localized or low grade (e.g., Gleason 3+3 or 3+4 with low prostate specific antigen) prostate cancer, superficial (non-muscle invasive) urothelial cancer, localized thyroid gland microcarcinoma, other in-situ carcinoma, or other malignancy for which participants are not on active antineoplastic therapy.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",{"count":545,"type":20},270,[94,176],"The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of \\[68Ga\\]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC), pancreatic ductal adenocarcinoma (PDAC), and colorectal cancer (CRC); Part B: is to determine the recommended phase 2 dose (RP2D) \\[maximum tolerated dose (MTD) or lower dose\\] for \\[177Lu\\]Lu-DPI-4452 for each tumor type such as ccRCC, PDAC, CRC, and urothelial carcinoma (UC); Part C: is to evaluate the preliminary antitumor activity of \\[177Lu\\]Lu-DPI-4452 as monotherapy for each tumor type such as ccRCC, PDAC, CRC, and UC; Part D: is to assess the diagnostic concordance between \\[68Ga\\]Ga-DPI-4452 Positron Emission Tomography (PET) and the histopathology result of the Indeterminate Renal Mass (IDRM); Part E: is to assess \\[68Ga\\]Ga-DPI-4452 uptake in each tumour type such as UC, muscle invasive bladder cancer (MIBC), head and neck cancer (H\\&N), triple negative breast cancer (TNBC), squamous non-small cell lung cancer (NSCLC), and any other tumor with locally confirmed carbonic anhydrase (CA) IX expression except ccRCC, CRC and PDAC.",[360,549,153,24,550,330,551,552,553],"Pancreatic Ductal Adenocarcinoma (PDAC)","Indeterminate Renal Mass (IDRM)","Head and Neck Cancer (H&N)","Triple Negative Breast Cancer (TNBC)","Squamous Non-Small Cell Lung Cancer (NSCLC)","2025-10-16",{"date":556,"type":44},"2025-10-20",{"date":558,"type":44},"2023-03-14",{"date":377,"type":20},{"name":561,"class":133},"ITM Oncologics GmbH",{"id":563,"slug":564,"hasResults":11,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":52},"100591620","a-patient-directed-mobile-tool-to-streamline-the-qol-assessment-and-monitoring-in-urothelial-carcinoma-100591620","NCT06982794","A Patient-Directed Mobile Tool to Streamline the QoL Assessment and Monitoring in Urothelial Carcinoma","'UROLIFE': a Patient-Directed Mobile Tool to Streamline the QoL Assessment and Monitoring in Urothelial Carcinoma","Urolife","Inclusion Criteria:\n\n* histological diagnosis of urothelial carcinoma;\n* ≥ 18 years old,\n* candidate for systemic treatment with chemotherapy, immune-checkpoint inhibitors, antibody-drug conjugates, or target therapy (patients can be enrolled also if the treatment has started),\n* possession of a mobile device (e.g., smartphone or personal computer) with the physical and psychological ability to use mobile devices,\n* understanding and speaking the Italian language,\n* ability to sign an informed consent.\n\nExclusion Criteria:\n\n* not possession of a mobile device,\n* unwillingness to give informed consent.",{"count":571,"type":20},50,"The goal of this observational study is to select contents and tools for the future development of a web app aiming to support patients' navigation for empowering decision-making through a higher awareness of urothelial carcinoma and its treatments, improving also educational aspects.\n\nThe main question it aims to answer is:\n\nWhat are the contents that patients diagnosed with urothelial carcinoma find useful to include in a web app to streamline their quality of life assessment and monitoring?\n\nParticipants candidate for systemic treatments, or already under treatment, will answer questionnaires about the tools to include in a web app designed for urothelial carcinoma.",[24],[575,576,577,578,579,580,581],"Quality of life","Self-education","Educational","Urothelial carcinoma","Web-app","Mobile tool","Design-thinking","2025-05-13",{"date":584,"type":44},"2025-05-21",{"date":586,"type":20},"2025-06-30",{"date":588,"type":20},"2025-10-31",{"name":590,"class":51},"IRCCS San Raffaele"]