[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasm-metastasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasm-metastasis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,47,77,92,104,126,154,176,223,251,275,305,333,363,395,432,457,482,512,533,562],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053764","phase-3-a-study-of-vepugratinib-ly3866288-in-participants-with-cancer-in-the-urinary-tract-100053764",false,"NCT07218380","A Study of Vepugratinib (LY3866288) in Participants With Cancer in the Urinary Tract","FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined With Enfortumab Vedotin and Pembrolizumab in Adults With Untreated Locally Advanced or Metastatic Urothelial Carcinoma With an FGFR3 Genetic Alteration","FORAGER-2","Inclusion Criteria:\n\n* Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present.\n* Have a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration determined via molecular testing from a tumor or blood sample obtained at or any time after diagnosis of advanced or metastatic urothelial cancer.\n* Have measurable disease by investigator assessment defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Have adequate laboratory parameters\n\nExclusion Criteria:\n\n* Have received prior systemic therapy for locally advanced or metastatic urothelial cancer (mUC).\n* Have any unresolved toxicities greater than Grade 1 Common Terminology Criteria for Adverse Events (\\[CTCAE\\] version 5.0) from prior neoadjuvant or adjuvant systemic therapy.\n* Have ongoing sensory or motor neuropathy of Grade 2 or higher\n* Have untreated or uncontrolled central nervous system (CNS) involvement or any history of leptomeningeal disease.\n* Current evidence corneal keratopathy or retinal disorder confirmed by ocular examination at screening.","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread.\n\nVepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab.\n\nStudy participation could last up to approximately 6 years.",[27,28,29],"Carcinoma, Transitional Cell","Urinary Bladder Neoplasms","Neoplasm Metastasis",[31,32,33],"FGFR3","Advanced Urothelial Carcinoma","Metastatic Urothelial Carcinoma","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2025-12-12",{"date":42,"type":21},"2033-05",{"name":44,"class":45},"Eli Lilly and Company","INDUSTRY",286,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100053259","pluvicto-real-world-investigation-in-survival-in-metastatic-crpc-100053259","NCT07697989","Pluvicto Real-world Investigation in Survival in Metastatic CRPC","Real World Clinical Effectiveness of [177Lu]Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients: A Non-Interventional Study","PRISM","Inclusion criteria:\n\n1. Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \\[ICD-10-CM\\]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date.\n2. Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date.\n3. Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.\n4. Patients with evidence of treatment with \\[177Lu\\]Lu-PSMA-617 after the mCRPC diagnosis date. The date of \\[177Lu\\]Lu-PSMA-617 administration will be considered as the index date.\n5. Patients ≥18 years of age on metastatic diagnosis date.\n6. Patients who are male.\n7. Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap).\n\nExclusion criteria:\n\n1. Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis.\n2. Patients enrolled in a current clinical trial\u002Finvestigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6).\n3. Patients with missing age and gender information.","MALE",{"count":57,"type":21},1085,"OBSERVATIONAL","This study aims to evaluate the various aspects of treatment effectiveness of \\[177Lu\\]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.",[61,29],"Prostatic Neoplasms, Castration-Resistant",[63,64,65,66,67],"Pluvicto","177Lu-PSMA-617","Metastatic Castration Resistant Prostate Cancer","Effectiveness","Survival","NOT_YET_RECRUITING","2026-07-06",{"date":37,"type":38},{"date":72,"type":21},"2026-06-30",{"date":74,"type":21},"2026-10-31",{"name":76,"class":45},"Novartis Pharmaceuticals",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":91,"locationsCount":4},"100644897","expanded-access-for-vepugratinib-ly3866288-in-participants-with-fibroblast-growth-factor-receptor-3-fgfr3-altered-solid-tumors-100644897","NCT07675057","Expanded Access for Vepugratinib (LY3866288) in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Expanded Access for Vepugratinib in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors","Inclusion Criteria:\n\n* Have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration.\n* Have exhausted other approved treatments, including erdafitinib for UC.\n* Are not eligible for an ongoing vepugratinib clinical trial\n\nExclusion Criteria:\n\n* Currently enrolled in an ongoing clinical study of vepugratinib\n* Have a known severe (greater than or equal to (≥) Grade 3) hypersensitivity to any component or excipient of vepugratinib.\n* Current evidence of corneal keratopathy or retinal disorder confirmed by ocular examination. Exception: Individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk.\n* Significant cardiovascular disease:\n* Are pregnant, breastfeeding, or intent to become pregnant during the study or within 6 months of the last dose of study intervention.","EXPANDED_ACCESS","The treating physician\u002Finvestigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.",[28,29,27],[33],"AVAILABLE","2026-06-23",{"date":72,"type":38},{"name":44,"class":45},{"id":93,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":25,"conditions":96,"keywords":97,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":102,"locationsCount":103},"100609730",{"count":20,"type":21},[24],[27,28,29],[31,32,33],"2026-06-19",{"date":89,"type":38},{"date":40,"type":38},{"date":42,"type":21},{"name":44,"class":45},284,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":125},"100606344","phase-3-a-study-of-tersolisib-ly4064809stx-478-with-other-anti-cancer-treatments-in-participants-with-advanced-breast-cancer-with-a-genetic-change-pik3ca-100606344","NCT07174336","A Study of Tersolisib (LY4064809\u002FSTX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4\u002F6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)","Inclusion Criteria:\n\n* Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* If assigned female at birth, pre-\u002Fperi- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.\n* If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.\n* Have histologically or cytologically confirmed breast cancer, defined as individuals with\n\n  * locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and\n  * hormone receptors (HR)+\u002Fhuman epidermal growth factor receptor 2 (HER2)- or HR+\u002FHER low defined by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Guidelines\n\n    * HR status: Documented ER+ and\u002For progesterone receptor-positive (PR+) tumor according to ASCO\u002FCAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally\n    * HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO\u002FCAP Guidelines\n* Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.\n* Have measurable disease or non-measurable, evaluable bone disease\n* Part 1:\n\n  * Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Up to 1 of these prior systemic treatments may contain chemotherapy\n* Part 2:\n\n  * Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Individuals who are eligible are either\n\n    * Population 1 (P1): Endocrine sensitive\n\n      * newly diagnosed with advanced breast cancer (de novo)\n      * relapsed with documented evidence of progression greater than (\\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitor, or\n    * Population 2 (P2): Endocrine resistant\n\n      * relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4\u002F6 inhibitor.\n      * if a CDK4\u002F6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \\>12 months since completion of CDK4\u002F6 inhibitor portion of neoadjuvant or adjuvant therapy.\n\nExclusion Criteria:\n\n* Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg\u002FdL) (7.7 millimoles per liter \\[mmol\u002FL\\]), or requiring insulin.\n* Have inflammatory or metaplastic breast cancer.\n* History of leptomeningeal disease or carcinomatous meningitis.\n* Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.\n* Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.\n* Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \\[mg\\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and\u002For CDK4\u002F6 inhibitor after the final administration of study treatment.",{"count":112,"type":21},920,[24],"The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809\u002FSTX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.",[116,29],"Breast Neoplasms",[118,119],"STX-478","PI3K",{"date":89,"type":38},{"date":122,"type":38},"2025-12-22",{"date":42,"type":21},{"name":44,"class":45},330,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":138,"conditions":139,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100601754","phase-1-a-study-of-ly4257496-in-participants-with-cancer-omniray-100601754","NCT07114601","A Study of LY4257496 in Participants With Cancer (OMNIRAY)","A Phase 1a\u002Fb Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","OMNIRAY","Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)\u002Fhuman epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+\u002FHER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO\u002FCAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection\u002Fdisease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\\u003C400 copies\u002FmL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells\u002FmL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.",{"count":135,"type":21},421,[137],"PHASE1","The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.",[116,140,141,142,29,143,144],"Colorectal Neoplasms","Prostate Neoplasm","Endometrial Neoplasms","Stomach Neoplasms","Esophageal Neoplasms",[146],"GRPR-positive",{"date":89,"type":38},{"date":149,"type":38},"2025-08-06",{"date":151,"type":21},"2035-04",{"name":44,"class":45},32,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100596550","phase-1-a-study-of-ly4175408-in-participants-with-advanced-cancer-100596550","NCT07046923","A Study of LY4175408 in Participants With Advanced Cancer","A First-in-Human, Phase 1a\u002F1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Have one of the following advanced or metastatic solid tumor cancers:\n\n  * Non-small cell lung cancer (NSCLC)\n  * Small cell lung cancer (SCLC)\n  * Endometrial cancer\n  * Triple negative breast cancer (TNBC) (characterized by HR-negative disease and HER2-negative expression according to American Society of Clinical Oncology (ASCO) - College of American Pathologists guidelines).\n* Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator (except in Cohort B1 and B2 expansion, which require participants who are treatment naive in the advanced metastatic setting); OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of greater than or equal to (≤) 1.\n* For dose optimization\u002Fdose and expansion cohorts (Cohort A2, Cohort B\u002FC): Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Cohorts B1\u002FB2: NSCLC with no known actionable genomic alterations. ≤2 prior lines of systemic therapy for advanced or metastatic disease in safety lead-in; no prior systemic therapy in expansion\n\nExclusion Criteria:\n\n* Prior treatment with a protein tyrosine kinase 7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor as payload (prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted). Prior topoisomerase I-based ADCs are not allowed in cohorts A2, B1 or B2.\n* Any serious unresolved toxicities from prior therapy.\n* Individual with known or suspected history of uncontrolled central nervous system (CNS) metastases.\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.\n* Significant cardiovascular disease.\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 milliseconds (ms)\n* History of pneumonitis\u002Finterstitial lung disease.\n* Individuals who are pregnant, breastfeeding, or plan to breastfeed during the trial or within 30 days of the last dose of trial intervention.",{"count":162,"type":21},240,[137],"The purpose of this study is to measure the safety and efficacy of LY4175408 in participants with selected advanced cancer. In addition, this study will evaluate how much LY4175408 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. Participation could last up to 4 years.",[166,167,142,29,168],"Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","Triple Negative Breast Cancer",{"date":89,"type":38},{"date":171,"type":38},"2025-07-28",{"date":173,"type":21},"2030-07",{"name":44,"class":45},27,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":185,"type":21},1264,[24],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[166,29],[190,191,192,193,194,195,196,197,198,199,200,201,202,29,203,204,205,206,207,208,209,210,211,212,213],"Advanced Non-Small Cell Lung Cancer","KRAS G12 Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Lung Diseases","Neoplastic Processes","Pathologic Processes","Non-Small Cell Lung Cancer","Non-Small Cell Lung Cancer (NSCLC)","Antineoplastic Agents","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms","Lung Neoplasms","2026-06-17",{"date":216,"type":38},"2026-06-18",{"date":218,"type":38},"2023-12-21",{"date":220,"type":21},"2031-01",{"name":44,"class":45},420,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},"100486489","phase-1-forager-1-a-study-of-loxo-435-ly3866288-in-participants-with-cancer-with-a-change-in-a-gene-called-fgfr3-100486489","NCT05614739","FORAGER-1: A Study of LOXO-435 (LY3866288) in Participants With Cancer With a Change in a Gene Called FGFR3","FORAGER-1: A Phase 1, Open-Label, Multicenter Study of LOXO-435 (LY3866288) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer With FGFR3 Alterations","FORAGER-1","Inclusion Criteria:\n\n* Have solid tumor cancer with an FGFR3 pathway alteration on molecular testing in tumor or blood sample that is deemed as actionable\n\n  * Cohort A1: Presence of an alteration in FGFR3 or its ligands\n  * Cohort A2, B2, B3, and B5: Histological diagnosis of urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration\n  * Cohorts B1 and B4: Histological diagnosis of urothelial cancer that is locally advanced or metastatic\n  * Cohort C1: Must have histological diagnosis of a non-urothelial solid tumor malignancy that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration\n* Measurability of disease:\n\n  * Cohort A1 and B3: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1)\n  * Cohorts A2, B1, B2, B4, B5, and C1: Measurable disease required as defined by RECIST v1.1\n* Have adequate tumor tissue sample available. Participants with inadequate tissue sample availability may still be considered for enrollment upon review\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Cohorts A1, A2, B3, and B5\n\n  * Less than or equal to 2 for Cohorts B1, B2, B4, and C1\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC1: Participant has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating Investigator; OR the participant is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies.\n  * Cohort A2, B2, B3 participants must have received at least one prior regimen, and cohorts B1 and B4 participants at least 2 prior regimens, in the locally advanced or metastatic setting\n  * There is no restriction on number of prior therapies\n* Cohort B5: Participants have not received prior systemic therapy for locally advanced or metastatic UC\n* FGFR inhibitor specific requirements:\n\n  * Cohort A1\u002FA2\u002FB3: Prior FGFR inhibitor treatment is permitted but not required\n  * Cohort B1\u002FB4: Participants must have been previously treated with erdafitinib\n  * Cohort B2, B5, and C1: Participants must be FGFR inhibitor naïve\n\nExclusion Criteria:\n\n* Participants with primary central nervous system (CNS) malignancy\n* Untreated or uncontrolled CNS metastases\n* Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)\n* Active uncontrolled systemic infection or other clinically significant medical conditions\n* Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled",{"count":232,"type":21},535,[137],"The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-435 by itself or when it is combined with other standard medicines that treat cancer. LOXO-435 may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Participation could last up to 30 months (2.5 years) and possibly longer if the disease does not get worse.",[28,29,236],"Ureteral Neoplasms",[238,239,240,241,242,243],"Bladder Cancer","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Renal Pelvis Cancer","Ureter Cancer",{"date":216,"type":38},{"date":246,"type":38},"2023-01-12",{"date":248,"type":21},"2027-06",{"name":44,"class":45},82,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100641305","early-phase-1-inhaled-mrna-immunotherapy-for-patients-with-advanced-lung-cancer-or-pulmonary-metastatic-solid-tumors-100641305","NCT07657611","Inhaled mRNA Immunotherapy for Patients With Advanced Lung Cancer or Pulmonary Metastatic Solid Tumors","A Platform Study of In Vivo Inhaled mRNA Technology for Multi-Target Immunotherapy Against Solid Tumors","BMD-PLAT","Inclusion Criteria:\n\n1. Male or female patients aged ≥ 18 years.\n2. Confirmed diagnosis of advanced lung cancer (driver gene negative or targeted therapy failed) or pulmonary metastatic solid tumors, with no standard treatment options available or who have failed prior standard therapies.\n3. Presence of at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function, including hematologic, hepatic, and renal function.\n6. Ability to understand and sign the informed consent form.\n7. Expected survival of at least 12 weeks.\n\nExclusion Criteria:\n\n1. History of severe hypersensitivity to mRNA-based therapies or components of the study drug.\n2. Uncontrolled active infection or severe underlying respiratory disease (e.g., severe COPD, asthma requiring high-dose steroids).\n3. Prior allogeneic stem cell or solid organ transplantation.\n4. Current use of other investigational agents within 4 weeks before the first dose of study treatment.\n5. Active autoimmune disease requiring systemic immunosuppressive therapy.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, would interfere with study compliance or safety.",{"count":260,"type":21},60,[262],"EARLY_PHASE1","This is an open-label phase I master platform study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of multiple inhaled in-vivo mRNA immunotherapies in adult patients with advanced solid tumors. Subjects will receive inhalation mRNA formulations at ascending dose levels following a 3+3 dose-escalation design to determine maximum tolerated dose and recommended phase II dose.",[209,265,29],"Solid Tumors","2026-06-14",{"date":216,"type":38},{"date":269,"type":21},"2026-06-10",{"date":271,"type":21},"2029-12",{"name":273,"class":274},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100609378","phase-3-a-three-part-phase-3-study-of-sofetabart-mipitecan-in-participants-with-platinum-resistant-part-a-and-platinum-sensitive-parts-b-and-c-ovarian-cancer-100609378","NCT07213804","A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer","FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.","FRAmework-01","Inclusion Criteria:\n\nPart A, B, and C:\n\n* Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.\n* Have confirmed availability of tumor tissue block or slides\n* Have radiographic progression on or after most recent line of systemic anticancer therapy\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Have measurable disease per RECIST v1.1\n\nPart A:\n\n* Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.\n* Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.\n* Have received prior bevacizumab treatment, unless documented contraindication or intolerance.\n* Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.\n\nPart B and C:\n\n* Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\\>)6 months of their last administration of platinum therapy\n* Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy\n\nPart B:\n\n\\- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.\n\nPart C:\n\n\\- Have not previously received a PARPi treatment.\n\nExclusion Criteria:\n\nParts A, B and C:\n\n\\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.\n\nPart A:\n\n* Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.\n\nPart B and C:\n\n\\- Have clinically significant proteinuria\n\nPart C:\n\n\\- Have a known pathogenic BRCA1\u002F2 gene alteration (somatic or germline).",{"count":284,"type":21},1630,[24],"This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.",[288,289,290,29],"Ovarian Neoplasms","Fallopian Tube Neoplasms","Peritoneal Neoplasms",[292,293,294,295],"Folate Receptor Alpha","Antibody-drug Conjugate","Platinum-Resistant","Platinum-Sensitive","2026-06-11",{"date":298,"type":38},"2026-06-15",{"date":300,"type":38},"2025-10-22",{"date":302,"type":21},"2031-08",{"name":44,"class":45},261,{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":332},"100483350","providence---prospective-non-interventional-study-nis-to-examine-patient-reported-outcomes-and-real-world-clinical-data-in-patients-with-her2-positive-her2-low-or-her2-ultralow-unresectable-or-metastatic-breast-cancer-treated-with-trastuzumab-deruxtecan-100483350","NCT05573893","PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan","Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan","PROVIDENCE","Inclusion Criteria:\n\n1. Adults ≥ 18 years old\n2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that:\n\n   * is unresectable or metastatic\n   * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology\n   * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR\n   * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR\n   * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low.\n3. Has documented radiologic progression (during or after most recent treatment)\n4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \\*\n5. Patient is able to read and understand either German or English\n6. Signed written informed consent\n\n   * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.\n\nExclusion Criteria:\n\n1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)\n2. Known hypersensitivity to T-DXd or any of the excipients of the drug\n3. Pregnancy or breast feeding\n4. Current or planned participation in an interventional clinical trial\n5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC\n\nPatients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.","130 Years",{"count":315,"type":21},800,"This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).",[116,318,29],"Breast Cancer",[320,321,322,323],"Trastuzumab-Deruxtecan,","Human epidermal growth factor receptor 2 Positive Breast Cancer,","Human epidermal growth factor receptor 2 Low Breast Cancer,","Human epidermal growth factor receptor 2 Ultralow Breast Cancer,",{"date":325,"type":38},"2026-06-12",{"date":327,"type":38},"2023-09-12",{"date":329,"type":21},"2031-12-31",{"name":331,"class":45},"AstraZeneca",107,{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":343,"conditions":344,"keywords":348,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100309067","phase-3-a-study-of-2nd-line-folfiri--bevacizumab-vs-irinotecan--bevacizumab-in-mcrc-100309067","NCT03303495","A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC","A Multinational, Randomized, Phase III Study of FOLFIRI With\u002FWithout Bevacizumab Versus Irinotecan With\u002FWithout Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Histologically-confirmed inoperable colorectal adenocarcinoma excluding vermiform appendix cancer and anal canal cancer.\n2. Age ≥18 years at the time of informed consent\n3. ECOG performance status (PS) of 0-2\n4. Written informed consent prior to study-specific screening procedures\n5. Life expectancy of at least 90 days\n6. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy.\n7. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: ≥1500\u002Fmm3 Platelet count: ≥10.0 x 104\u002Fmm3 Hemoglobin: ≥9.0 g\u002FdL Total bilirubin: ≤1.5 mg\u002FdL AST, ALT: ≤100 IU\u002FL (≤200 IU\u002FI if liver metastases present) Serum creatinine: ≤1.5 mg\u002FdL\n\nExclusion Criteria:\n\n1. History of other malignancy with a disease-free interval \\\u003C5 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection)\n2. With massive pleural effusion or ascites requiring intervention\n3. Radiological evidence of brain tumor or brain metastases\n4. Active infection including hepatitis\n5. Any of the following complication:\n\n   i) Gastrointestinal bleeding or gastrointestinal obstruction (including paralytic ileus) ii) Symptomatic heart disease (including unstable angina, myocardial infarction, and heart failure) iii) Interstitial pneumonia or pulmonary fibrosis iv) Uncontrolled diabetes mellitus v) Uncontrolled diarrhea (that interferes with daily activities despite adequate therapy)\n6. Any of the following medical history:\n\n   Myocardial infarction: History of one episode within one year before enrollment or two or more lifetime episodes i) Serious hypersensitivity to any of the study drugs ii) History of adverse reaction to fluoropyrimidines suggesting dihydropyrimidine dehydrogenase (DPD) deficiency\n7. Previous treatment with irinotecan hydrochloride\n8. Current treatment with atazanavir sulfate\n9. Previous treatment with tegafur, gimeracil, and oteracil potassium within seven days before enrollment\n10. Pregnant or lactating females, and males and females unwilling to use contraception\n11. Requires continuous treatment with systemic steroids\n12. Psychiatric disability that would preclude study compliance\n13. Otherwise determined by the investigator to be unsuitable for participation in the study\n14. Concurrent gastrointestinal perforation or history of gastrointestinal perforation with 1 year before enrollment\n15. History of pulmonary hemorrhage\u002Fhemoptysis ≥ Grade 2 (defined as bright red blood of at least 2.5mL) within 1 month prior to enrollment.\n16. History of laparotomy, thoracotomy, or intestinal resection within 28 days before enrollment\n17. Unhealed wound (except suture wounds from implantation of a central venous port), gastrointestinal ulcer, or traumatic fracture\n18. Current or recent (within 1 year) thromboembolism or cerebrovascular disease\n19. Currently receiving or requires anticoagulation therapy (\\> 325 mg\u002Fday of aspirin)\n20. Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within 14 days before enrollment)\n21. Uncontrolled hypertension\n22. Urine dipstick for proteinuria \\>+2",{"count":341,"type":21},280,[24],"The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.",[140,29,345,346,347],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms",[349,350,351,352],"FOLFIRI","CPT-11","Bevacizumab","2nd-line metastatic colorectal cancer","2026-06-03",{"date":355,"type":38},"2026-06-05",{"date":357,"type":38},"2011-11-14",{"date":359,"type":21},"2026-12-31",{"name":361,"class":274},"Sun Yat-sen University",1,{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":373,"conditions":374,"keywords":379,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":362},"100441087","laser-interstitial-thermal-ablation-and-stereotactic-radiosurgery-for-patients-with-spine-metastases-100441087","NCT05023772","Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases","A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases","Inclusion Criteria:\n\n* Age \\> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)\n* Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.\n* Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.\n* The vertebral body site to be treated must be located from T2 to L1\n* No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.\n* Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).\n* ECOG performance status \\\u003C2 or Karnofsky performance status (KPS) \\>50\n* Life expectancy \\>3 months.\n* Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Requires open spinal procedure or a percutaneous procedure without the use of image guidance.\n* Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.\n* Unable to tolerate general anesthesia and prone position.\n* Unable to undergo MRI scan of the spine.\n* Inability to lie flat on a treatment table for \\>60 minutes.\n* Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)\n* Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.\n* Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength \\\u003C4\u002F5 in extremity or extremities affected by the level of the spinal cord compression)",{"count":260,"type":21},[372],"NA","The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.",[29,375,376,377,378],"Spinal Cord Diseases","Spinal Cord Compression","Spinal Cord Tumor","Spine Metastases",[380,381,382,383,384,385,386],"Laser Ablation","Spinal Cord","Minimally Invasive Surgical Procedure","Stereotactic Radiosurgery","Pain Control","Metastasis","Epidural Tumor","2026-06-02",{"date":353,"type":38},{"date":390,"type":38},"2021-09-02",{"date":392,"type":21},"2028-06-20",{"name":394,"class":274},"Henry Ford Health System",{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":11,"sex":402,"minAge":18,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":362},"100557009","phase-2-cadonilimab-with-chemoradiation-for-recurrent-and-oligometastatic-endometrial-carcinoma-100557009","NCT06532539","Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma","A Phase II, Single-arm, Multicenter Clinical Trial of Definitive Treatment With Cadonilimab, Paclitaxel, Cisplatin and Radiation for the Treatment of Locally Recurrent and Oligometastatic Endometrial Carcinoma","Inclusion Criteria:\n\n1. A written informed consent form must be signed before the implementation of any trial-related procedures.\n2. Female, aged 18 years or older and 80 years or younger.\n3. ECOG PS 0-1.\n4. Newly diagnosed with histologically or cytologically confirmed primary endometrioid adenocarcinoma, serous carcinoma, clear cell adenocarcinoma, undifferentiated carcinoma, mixed cell adenocarcinoma, mesonephric adenocarcinoma, mucinous carcinoma, intestinal-type mesonephric-like adenocarcinoma, and carcinosarcoma, meeting the clinical diagnostic criteria for endometrial cancer.\n5. Patients with locally recurrent or oligometastatic endometrial cancer after initial treatment. The number of recurrent and metastatic lesions is ≤5. Screening criteria for oligometastasis: lymph node metastases in the same region count as one metastatic lesion; liver metastases are limited to one; lung metastases are limited to three.\n6. At least one site suitable for radiotherapy (including the primary lesion), measurable, and meeting the RECIST v1.1 criteria for evaluable lesions.\n7. Tumor samples available for biomarker assessment.\n8. Expected survival time ≥6 months.\n9. Normal major organ function (within 7 days before enrollment), meeting the following criteria:\n\n(1) Hematology standards (without blood transfusion or hematopoietic growth factor treatment within 14 days before enrollment):\n\n1. Hemoglobin (HB) ≥80 g\u002FL;\n2. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL;\n3. Platelet count (PLT) ≥50×10\\^9\u002FL; (2) No functional or organic diseases, meeting the following criteria:\n\na) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, total serum bilirubin ≤1.5×ULN, alkaline phosphatase (ALP) ≤3×ULN, serum albumin ≥30 g\u002FL; b) Serum creatinine (Cr) ≤1.5×ULN; if serum creatinine is \\>1.5×ULN, creatinine clearance (CrCl) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); c) Prothrombin time (PT) prolongation ≤6 seconds, activated partial thromboplastin time (APTT) ≤1.5×ULN; d) Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, FT3 and FT4 levels should be considered; if FT3 and FT4 levels are normal, enrollment is allowed); f) Left ventricular ejection fraction (LVEF) \\>50%. 11. Before starting the first treatment, all reversible toxic reactions from previous anti-tumor treatments must have resolved to ≤ grade 1 (based on CTCAE v5.0), excluding any grade of alopecia and pigmentation, ≤ grade 2 peripheral sensory neuropathy, and other abnormalities considered by the investigator and\u002For sponsor to pose a benefit-risk balance favoring the subject receiving the study treatment.\n\n12\\. Non-surgically sterilized or childbearing potential female patients must use medically recognized contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment. Non-surgically sterilized childbearing potential female patients must have a negative serum or urine HCG test within 7 days before enrollment and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved and does not require any intervention in adulthood may be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible).\n2. Subjects currently using immunosuppressive agents or systemic, or absorbable local corticosteroid therapy to achieve immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) and continuing use within 2 weeks prior to enrollment.\n3. Known history of grade 3 or 4 immune-related adverse events associated with previous anti-tumor immunotherapy.\n4. Poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past six months; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc \\>450 ms (males); QTc \\>470 ms (females).\n5. Coagulation dysfunction (INR \\>1.5 or PT \\>16 s), bleeding tendency, or receiving thrombolytic or anticoagulant therapy.\n6. Subjects who have received radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy within 4 weeks (or 5 drug half-lives, whichever is longer) prior to the first dose of the study drug; subjects with adverse events from previous treatments (excluding alopecia) that have not recovered to ≤CTCAE grade 1.\n7. Subjects with clinically uncontrolled third-space effusion requiring puncture drainage or other local treatment prior to the first dose of the investigational drug.\n8. Subjects with significant hemoptysis within 2 months before randomization, or hemoptysis of at least half a teaspoon (2.5 ml) per day.\n9. Known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism).\n10. Subjects with active infection or unexplained fever \\>38.5°C during the screening period or prior to the first dose.\n11. Subjects with a history of or current evidence of lung fibrosis, interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function.\n12. Subjects with congenital or acquired immune deficiencies (e.g., HIV infection) or active hepatitis (hepatitis B reference: HBV DNA exceeding the upper limit of normal; hepatitis C reference: HCV viral load or RNA exceeding the upper limit of normal).\n13. Subjects who have used other investigational drugs or similar therapeutic agents within 4 weeks prior to the first dose or who have received radiotherapy or other local treatments within 2 weeks prior to the first dose and have not recovered from the adverse effects of such treatments.\n14. Subjects with a history of or concurrent other malignancies (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n15. Subjects who may receive other systemic anti-tumor therapies during the study period.\n16. Subjects who have received or are expected to receive live vaccines within 4 weeks prior to the first dose or during the study period.\n17. Subjects with other factors that may lead to forced termination of the study as judged by the investigator, such as severe diseases (including mental disorders) requiring combined treatment, severe laboratory abnormalities, and family or social factors that may affect the safety of the subject or the collection of data and samples.","FEMALE","80 Years",{"count":405,"type":21},30,[407],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of cadonilimab in combination with paclitaxel, cisplatin, and radiation therapy for the treatment of locally recurrent and oligometastatic endometrial carcinoma. The main questions it aims to answer are:\n\n1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?\n2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy?\n\nParticipants will:\n\n* Receive cadonilimab, paclitaxel, cisplatin, and radiation therapy according to a specified protocol.\n* Visit the clinic for regular checkups and tests throughout the treatment period.\n* Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety.\n* Provide hematologic and tissue samples to explore biomarkers.\n\nThis study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic endometrial carcinoma, as well as identify biomarkers to better guide treatment strategies.",[142,410,29],"Neoplasm Recurrence, Local",[412,413,414,415,416,417,418,419,420,421,422],"Immunotherapy","Cadonilimab","Paclitaxel","Cisplatin","Radiation Therapy","Combined Modality Therapy","Clinical Trials, Phase II as Topic","Progression-Free Survival","Biomarkers, Tumor","Treatment Outcome","Safety","2026-04-21",{"date":425,"type":38},"2026-04-24",{"date":427,"type":38},"2024-06-13",{"date":429,"type":21},"2026-09",{"name":431,"class":274},"Shandong Cancer Hospital and Institute",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":362},"100586185","phase-1-dose-finding-study-of-zanzalintinib-with-pembrolizumab-and-cetuximab-in-head-and-neck-scc-100586185","NCT06912087","Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC","A Phase I Study of Zanzalintinib With Pembrolizumab and Cetuximab in Patients With Recurrent and\u002For Metastatic Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC), which is considered incurable by local therapies.\n* Primary tumor locations: oropharynx, oral cavity, hypopharynx, larynx, nasopharynx, and sinonasal. Unknown primary is also eligible.\n* Age: Participants must be at least 18 years old.\n* ECOG Performance Status: Must be 0-1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.\n* For oropharyngeal cancer: HPV (p16) testing is required. p16 Immunohistochemistry (IHC) is sufficient for Human Papillomavirus (HPV) testing.\n* Programmed cell death ligand 1 (PD-L1) combined positive score (CPS) : For patients with previously untreated R\u002FM disease, a combined positive score (CPS) of 1 or greater is required. There is no PD-L1 restriction for patients who have previously received anti-PD(L)1 therapy.\n* Recovery to baseline or ≤ Grade 1 severity (CTCAE v5) from any adverse events (AEs), including immune-related AEs from prior treatments.\n* Adequate organ and marrow function, including:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n* Platelets ≥ 100,000\u002Fmm3.\n* Hemoglobin ≥ 9 g\u002FdL.\n* Normal liver and kidney function.\n* Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n* Contraception: Sexually active fertile subjects must agree to use a highly effective method of contraception during the study and for 2 months after the last dose of cetuximab and 4 months after the last dose of pembrolizumab.\n\nExclusion Criteria:\n\n* Prior treatment with Zanzalintinib or other vascular endothelial growth factor receptor (VEGFR)-targeted therapies, -Cetuximab, or other epidermal growth factor receptor (EGFR) inhibitors.\n* More than two prior lines of systemic therapy in the recurrent\u002Fmetastatic setting.\n* Relapsed disease within 3 months of definitive therapy.\n* Prior treatment with small molecule kinase inhibitors, chemotherapy, biologic, or other anticancer therapies within certain time frames (2-4 weeks before the first dose of study treatment).\n* Brain metastases or cranial epidural disease unless stable after treatment for at least 4 weeks.\n* Concomitant anticoagulation with oral anticoagulants or platelet inhibitors, unless on stable doses of acceptable anticoagulants.\n* Active infection requiring systemic treatment or significant cardiovascular, gastrointestinal, or other serious health issues that may affect study participation.\n* Known or suspected autoimmune disease, except for specific conditions like type I diabetes or controlled skin disorders.\n* Pregnancy or breastfeeding: Women must not be pregnant or breastfeeding at screening.\n* Other malignancies within the past 2 years (except for certain low-grade cancers like localized skin cancers).",{"count":440,"type":21},36,[137],"This Phase I clinical trial evaluates the safety, tolerability, and optimal dosing of Zanzalintinib in combination with Pembrolizumab and Cetuximab in patients with recurrent and\u002For metastatic squamous cell carcinoma of the head and neck (R\u002FM HNSCC). The study aims to establish the maximally tolerated dose (MTD) and recommended Phase II dose (RP2D) while also exploring efficacy outcomes, including progression-free survival (PFS) and overall survival (OS).",[444,445,410,29,446,447],"Head and Neck Neoplasms","Carcinoma, Squamous Cell","Recurrent Squamous Cell Carcinoma","Metastatic Squamous Cell Carcinoma","2025-12-01",{"date":450,"type":38},"2025-12-02",{"date":452,"type":38},"2025-09-29",{"date":454,"type":21},"2027-06-05",{"name":456,"class":274},"University of Chicago",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":481},"100519636","clinical-genetic-and-environmental-determinants-of-prostate-cancer-progression-100519636","NCT06046131","Clinical, Genetic and Environmental Determinants of Prostate Cancer Progression.","KP-CARAIBES","Inclusion Criteria:\n\nInclusion criteria:\n\nAdult patients with incident case of prostate cancer Patient consulting the University Hospital of Guadeloupe or the University Hospital of Rennes Patient who resides in the departments of Guadeloupe or Martinique or the community of Saint-Martin or in Britany Patient affiliated or beneficiary of the social security signed consent\n\nExclusion Criteria:\n\nPhysical or mental health judjed by the investigator as precluding participation in the research Protected adults (guardianship, curatorship, safeguard of justice).",{"count":465,"type":21},3000,[372],"The course and progression of prostate cancer is highly variable, depending on the individual characteristics, the aggressiveness of the disease at the time of diagnosis as well as the ethno-geographic origins of the individuals. The general objective of the project is to identify the clinical, genetic and environmental determinants (risk factors) of the evolution, progression and complications of the disease according to the treatment options. Identifying modifiable and non-modifiable prognostic determinants of disease progression is a major challenge. This knowledge will help guide treatment choices but also, especially in high-risk populations (high incidence of disease) to better tailor prevention policies and possibly screening .",[469,470,471,29],"Prostatic Neoplasm","Adenocarcinoma","Neoplasm Recurrence","2025-11-14",{"date":474,"type":38},"2025-11-17",{"date":476,"type":38},"2023-02-28",{"date":478,"type":21},"2039-02-28",{"name":480,"class":274},"Centre Hospitalier Universitaire de la Guadeloupe",2,{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":492,"briefSummary":493,"conditions":494,"keywords":497,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":481},"100604597","phase-2-testing-two-different-drugs-sacituzumab-govitecan-and-trastuzumab-deruxtecan-combinations-prescribed-in-an-alterning-pattern-to-patients-with-metastatic-or-locally-advanced-triple-negative-breast-cancer-100604597","NCT07151586","Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer","A Phase 2, Multicenter, Randomized, Open-label Trial Assessing Sacituzumab-govitecan and Trastuzumab-deruxtecan Combinations in an Alternating Regimen for Patients With Metastatic or Locally Advanced HER2-low Triple-negative Breast Cancer","ALTER","Inclusion Criteria:\n\n* Patient must have signed a written informed consent prior to any trial specific procedures. (Note : When the patient is physically unable to give his\u002Fher written consent, a impartial witness of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent)\n* Men or women ≥ 18 years of age\n* Histologically confirmed metastatic or locally advanced and unresectable triple-negative breast cancer, meeting both of the following criteria by local testing:\n\nHER2-low breast cancer, defined as either immunohistochemistry (IHC) 2+ \u002F in situ hybridization (ISH)-negative or IHC 1+ (ISH-negative or untested), on either the primary or any metastatic site\n\nEstrogen receptor (ER) expression \\\u003C10% and progesterone receptor (PR) expression \\\u003C10% (Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours correspond to a triple-negative breast cancer meeting the above criteria)\n\n* Patient eligible to receive sacituzumab-govitecan and T-Dxd according to their indication\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n* Women of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment for women and up to 4 months for men.\n\nA woman is considered to be of childbearing potential if she is not postmenopausal or has not undergone hysterectomy. Postmenopausal is defined as any of the following:\n\nAge ≥ 60 years Age \\\u003C 60 years and ≥ 12 continuous months of amenorrhea with no identified cause other than menopause Surgical sterilization (bilateral oophorectomy)\n\n\\- Adequate organ and bone marrow function within 28 days before enrollment. The most recent results available must be used for all parameters below:\n\nHemoglobin ≥ 9 g\u002FdL. Red blood cell transfusion is not allowed within 1 week prior to screening assessment\n\nAbsolute neutrophil count (ANC) ≥ 1,500\u002Fmm³. Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment\n\nPlatelet count ≥ 100,000\u002Fmm³. Platelet transfusion is not allowed within 1 week prior to registration\n\nTotal bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases, or \\\u003C 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline\n\nAlanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN, or \\\u003C 5 × ULN in patients with liver metastasis\n\nSerum albumin ≥ 2.5 g\u002FdL\n\nCreatinine clearance (CrCl) ≥ 30 mL\u002Fmin, calculated using the Cockcroft-Gault equation: CrCl (mL\u002Fmin) = \\[(140 - age in years) × weight in kg\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] (× 0.85 for females)\n\n* Adequate cardiac function, defined as a left ventricular ejection fraction ≥ 55% estimated by echocardiogram or multigated acquisition scintigraphy\n* Women of childbearing potential must have a negative serum or urine pregnancy test done within 7 days before randomization\n* Affiliated to the French Social Security System (or equivalent)\n* Patient willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n* Patient previously treated with any ADC targeting HER2 or TROP2\n* Patient with uncontrolled or significant cardiovascular disease\n* Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline\u002Fscreening brain MRI. Patients who require treatment of brain metastases are eligible after 14 days post surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening\n* Any medical history or condition that per protocol or in the opinion of the investigator is incompatible with the study\n* Patients with known allergy or severe hypersensitivity to any of the trial drugs or their excipients\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may cause misleading study interpretation or prevent completion of study procedures and followup examinations\n* Patients with any other disease or illness that requires hospitalisation or is incompatible with the trial treatment are not eligible\n* Patients enrolled in another therapeutic trial within 30 days of inclusion\n* Pregnant or breast-feeding women at the time of randomization or intention to become pregnant during the study and up to 7 months after treatment\n* Person deprived of their liberty or under protective custody or guardianship\n* Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons",{"count":491,"type":21},260,[407],"This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer.\n\nThe goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?",[495,29,496],"Triple Negative Breast Neoplasms","HER 2 Low-expressing Breast Cancer",[498,499,168,500,501,502],"Antibody-drug conjugates","HER2-low","Locally Advanced Breast Cancer","HER2-negative","Metastatic Breast Cancer","2025-08-25",{"date":505,"type":38},"2025-09-03",{"date":507,"type":21},"2025-10",{"date":509,"type":21},"2029-10",{"name":511,"class":274},"UNICANCER",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":362},"100317769","bone-metastases-database-of-patients-treated-surgically-for-impending-or-pathologic-fracture-of-long-bones-100317769","NCT03416959","Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long Bones","Prospective Bone Metastases Database","BMD","Inclusion Criteria:\n\n* Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction\n\nExclusion Criteria:\n\n* Patients with bone metastases of the spine",{"count":521,"type":21},120,"The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),",[29],"2025-07-29",{"date":526,"type":38},"2025-08-01",{"date":528,"type":38},"2018-01-01",{"date":530,"type":21},"2027-12-31",{"name":532,"class":274},"Istituto Ortopedico Rizzoli",{"id":534,"slug":535,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":542,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":561},"100452834","phase-1-emb-01-in-patients-with-advancedmetastatic-gastrointestinal-cancers-100452834","NCT05176665","EMB-01 in Patients With Advanced\u002FMetastatic Gastrointestinal Cancers","Phase Ib\u002FII, Open-Label Study of EMB-01 in Patients With Advanced\u002FMetastatic Gastrointestinal Cancers","Inclusion Criteria:\n\nMolecular Pre-screening Inclusion criteria\n\n1. cMET amplification in tumor sample; OR\n2. cMET overexpression in tumor sample; OR\n3. EGFR overexpression in tumor sample; OR\n4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA).\n\nIn Phase II, CRC patients must provide blood sample for NGS test, but may not provide tumor samples at prescreening visit. CRC patients don't need to meet the above criteria of EGFR\u002FcMET amplification, overexpression or gene aberration.\n\nScreening Inclusion Criteria\n\n1. Able to understand and willing to sign the Informed Consent Form (ICF).\n2. Histologically\u002Fcytologically confirmed advanced\u002Fmetastatic gastric cancer, HCC, BTC, and colorectal cancer with measurable disease (RECIST V1.1). To be eligible, patients must meet following criteria:\n\n   1. Have failed all standard of care therapies known to confer clinical benefit. Patients who is not tolerable on standard of care therapies, or no standard of care therapies available, or refused standard of care therapies are eligible.\n   2. Have measurable disease as defined by RESIST v 1.1.\n3. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year) or a new biopsy collected in the molecular pre-screening visit.\n4. Must have adequate organ function.\n5. Regarding prior anti-tumor therapy:\n\n   1. Patients who have received any anticancer drugs approved or investigational, including chemotherapy, immune therapy, hormonal therapy (Exceptions: hormone-replacement therapy, testosterone or oral contraceptives), biologic therapy, must have stopped treatment at least 4 weeks or within 5 half -lives whichever shorter before first dose of EMB-01.\n   2. Local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.\n   3. Patients who have received prior targeted therapies must have stopped treatment for at least 4 weeks or within 5 half-lives, whichever is shorter before first dose of EMB-01.\n6. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.\n7. ECOG score ≤1.\n\nExclusion Criteria:\n\nMolecular Pre-screening Exclusion Criteria\n\nSubject who meets any of the following criteria can't be proceeded to clinical screening:\n\n1. Patients who are unwilling to sign the molecular pre-screening ICF.\n2. Patients for whom the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.\n3. Patients with a documented gene alteration including but not limited to HER2, KRAS, NRAS, BRAF, NTRK, ALK, RET, ROS1, and FGFR, etc. that is known to confer resistance to EGFR and\u002For cMET inhibitors.\\* \\* In Phase II, CRC patients with activated KRAS, NRAS or BRAF mutation should be excluded, but patients with other gene alterations do not need to be excluded.\n\nScreening Exclusion Criteria\n\n1. Life expectancy \\\u003C 3 months.\n2. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNS metastases are eligible.\n3. Pregnant or nursing females.\n4. Patients who have had major surgery within the 28 days from the screening. Surgical wounds must be completely healed.\n5. Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":541,"type":21},152,[137,407],"This study is to evaluate the safety and antitumor activity of EMB-01 in advanced\u002Fmetastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.",[209,29,545],"Metastatic Gastrointestinal Carcinoid Tumor",[547,548,549,550,29,551],"Human Bispecific antibody","Epidermal Growth Factor Receptor (EGFR)","c-Mesenchymal-Epithelial Transition (cMet)","Neoplasms， Neoplasm Metastasis","EMB-01，Tyrosine Kinase Inhibitor (TKI) Resistant","2024-08-22",{"date":554,"type":38},"2024-08-26",{"date":556,"type":38},"2021-10-21",{"date":558,"type":21},"2025-12-31",{"name":560,"class":45},"Shanghai EpimAb Biotherapeutics Co., Ltd.",14,{"id":563,"slug":564,"hasResults":11,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":22,"phases":571,"briefSummary":572,"conditions":573,"keywords":575,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":588,"locationsCount":590},"100557549","phase-2-efficacy-and-resistant-mechanism-of-eribulin-and-bevacizumab-for-advanced-her2-negative-breast-cancer-100557549","NCT06539559","Efficacy and Resistant Mechanism of Eribulin and Bevacizumab for Advanced HER2 Negative Breast Cancer","Efficacy, Adverse Events and Resistant Mechanism of Eribulin Combined With or Without Bevacizumab for Advanced HER2 Negative Breast Cancer Patients, an Open-label, Randomized, Multi-center PhaseⅡ Clinical Trial.","Inclusion Criteria:\n\n1. Age ≥18 years old，and ≤75 years old.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n3. Expected survival period not less than 12 weeks.\n4. At least 1 measurable lesion according to RECIST 1.1 standard.\n5. previously treated with taxanes and\u002For anthracycline drugs in any stage of breast cancer.\n6. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) validated HER2 negative, including IHC- and IHC 1+\u002F2+ with FISH negative.\n7. at least prior 1 line of chemotherapy in the advanced stage.\n8. The organ function must meet the following requirements：\n\n(1). Blood Routine\n\n* ANC≥1.5×109\u002FL；\n* PLT≥90×109\u002FL；\n* Hb≥90 g\u002FL；\n\n  (2). Blood Biochemistry\n* TBIL≤1.5×ULN；\n* ALT and AST≤2×ULN；ALT和AST≤5×ULN for patients with liver metastasis；\n* BUN and Cr≤1.5×ULN and the Creatinine Clearance Rate ≥50 mL\u002Fmin (Cockcroft-Gault formula calculated)；\n\n  (3). Echocardiogram\n* LVEF≥50%；\n\n  (4). electrocardiogram\n* The QT interval (QTcF) corrected by Fridericia method less than 450 ms for male and less than 470 ms for female.\n\n  9\\. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. There is a third interstitial fluid accumulation that cannot be controlled by drainage or other methods (such as a large amount of hydrothorax and ascites).\n2. Symptomatic or uncontrolled brain or meningeal metastases.\n3. Patients with only bone or skin metastasis as the assessable lesion.\n4. Previously suffered from other malignant tumors.\n5. Those who have used Eribulin during the advanced disease stage.\n6. Individuals with a known history of allergies to the components of the interventions; History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases and a history of organ transplantation.\n7. Any heart disease or other conditions evaluated unsuitable by the researcher.\n8. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of reproductive age who are unwilling to take effective contraceptive measures throughout the trial period.\n9. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including severe bleeding tendency, history of surgery within 2 weeks, hypertension beyond drug control, serious diabetes, active infection, thyroid disease, etc.).\n10. Having a clear history of neurological or mental disorders, including epilepsy or dementia.\n11. According to the RECIST 1.1 criteria, researchers determined that patients who received the last anti-tumor regimen before enrollment did not experience disease progression.","75 Years",{"count":260,"type":21},[407],"This study is a prospective, multicenter, phase II randomized clinical trial. It is planned to enroll 60 patients with advanced HER2 negative breast cancer, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. The participants will receive either eribulin combined with bevacizumab or eribulin monotherapy. Every treatment cycle will last for 21 days, with weekly monitoring of blood routine, blood biochemistry and other indicators. Imaging examinations will be conducted every two cycles and the efficacy will be evaluated according to RECIST 1.1 standard. The life quality questionnaire is arranged at baseline and every 3 months after enrollment, and the long-time survival will be followed every 3 months after treatment. The primary endpoint is progression-free survival (PFS), the secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS). The investigators will also focus on the treatment-related adverse events (TRAE) and quality of life (QoL) assessment.\n\nAt the same time, this study also aims to explore the resistant mechanisms of anti-angiogenic drugs. The investigators plan to collect peripheral venous blood samples at 3 time points: baseline, during treatment, and end of treatment. All the dynamic samples will be used for transcriptome sequencing to obtain the gene sets. And based on the optimal therapeutic efficacy, all the participants will be divided into response group and non-response group. GO and KEGG enrichment analysis will be subsequently performed between different therapeutic efficacy groups to draw gene interaction networks, identify key action nodes and explain the mechanism of anti-angiogenic drug resistance.",[116,29,574,351],"Drug Therapy",[576,577,578,579,580,581],"breast cancer","HER2 negative","eribulin","bevacizumab","efficacy","resistant mechanism","2024-08-01",{"date":584,"type":38},"2024-08-06",{"date":582,"type":21},{"date":587,"type":21},"2026-08-01",{"name":589,"class":274},"Wang Jiayu",3]