[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,92,132,157,183,229,255,275,313,340],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100054099","phase-2-first-line-therapy-with-egfr-tki-combined-with-trastuzumab-rezetecan-for-advanced-nsclc-harboring-egfr-mutations-concomitant-with-her2-alterations-100054099",false,"NCT07699952","First-line Therapy With EGFR-TKI Combined With Trastuzumab Rezetecan for Advanced NSCLC Harboring EGFR Mutations Concomitant With HER2 Alterations","Inclusion Criteria:\n\n1. Aged 18-75 years, male or female without restriction;\n2. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1; Estimated survival time ≥ 3 months;\n3. Histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC);\n4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1);\n5. No prior systemic anti-tumor therapy before enrollment (oral EGFR-TKI administered within 2 weeks prior to screening is permitted);\n6. Confirmed EGFR mutations via genetic testing, including Exon 19 deletion or L858R point mutation;\n7. Presence of HER2 alterations, any of the following subtypes is acceptable: confirmed HER2 mutations or amplification by genetic testing; HER2 low expression or overexpression by immunohistochemistry (IHC 1+\u002F2+\u002F3+);\n8. Adequate laboratory parameters. No blood product transfusion or hematopoietic growth factor support administered within 14 days prior to the first study drug dose to correct lab abnormalities.\n9. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the initial study drug administration. 10. They must agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for 180 days after the last dose of study drug. Male subjects with female partners of childbearing potential must be surgically sterilized or agree to effective contraception during the study and for 180 days after the last study drug administration.\n\n11\\. Voluntarily participate in this trial, sign written informed consent, demonstrate good treatment compliance, and agree to complete all scheduled visits and study-related procedures.\n\n12\\. Estimated survival time ≥ 3 months.\n\nExclusion Criteria:\n\n1. Histologically confirmed tumor containing small cell lung cancer components.\n2. Medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid intervention, or any clinical evidence of active ILD.\n3. Symptomatic or actively progressive central nervous system (CNS) metastases or leptomeningeal metastases confirmed by CT\u002FMRI during screening and prior to radiological assessment.\n\n   Asymptomatic patients with stable CNS lesions who have received local therapy may be enrolled only if all of the following criteria are simultaneously met:\n\n   Fewer than 5 brain metastatic lesions; At least one measurable lesion per RECIST v1.1 exists outside the CNS; No history of intracranial or spinal hemorrhage; No neurosurgical resection within 28 days prior to the first study treatment dose, no whole-brain radiotherapy within 14 days, and no stereotactic radiotherapy within 7 days; Imaging confirms lesion stability for at least 4 weeks before enrollment, and systemic steroid therapy has been discontinued for more than 2 weeks (equivalent to ≤10 mg prednisone per day or equivalent steroids); Metastases do not involve the midbrain, pons, medulla oblongata, or spinal cord.\n4. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days before the first study drug administration. 5. Nasal\u002Finhaled corticosteroids or physiological doses of systemic steroids (i.e., ≤10 mg prednisolone per day or equivalent physiological doses of other corticosteroids) are excluded from this restriction.\n\n6\\. Received systemic anti-tumor vaccines, anti-tumor traditional Chinese herbal medicines, or immunomodulatory drugs (including thymopeptides, interferons, interleukins, excluding local administration for pleural effusion control) within 4 weeks prior to the first dose.\n\n7\\. Prior anti-HER2 therapy or anticipated need for any other anti-tumor treatment during the study.\n\n8\\. History of other malignant tumors within 5 years before enrollment, except for in situ carcinomas that have achieved complete remission after treatment and require no additional therapy during the trial.\n\n9\\. Received live attenuated vaccines within 4 weeks before the first dose or planned to receive such vaccines during the study.\n\n10\\. Currently receiving treatment in another interventional clinical trial, or administered any other investigational product\u002Fdevice within 4 weeks before the first study dose.\n\n11\\. Complicated with severe infection, localized infection within 4 weeks prior to the first dose (including but not limited to infectious complications requiring hospitalization or ≥2 weeks of intravenous antibiotics, bacteremia, severe pneumonia, etc.), or any active infectious disease.\n\n12\\. History of active tuberculosis infection within 1 year before the first dose.\n\nDiagnosis of any active, known or suspected autoimmune disease, or past medical history of autoimmune disease. Subjects with stable disease not requiring systemic immunosuppressants are eligible for enrollment.\n\nHBsAg positive with HBV DNA above the upper limit of normal (1000 copies\u002FmL or 500 IU\u002FmL); HCV positivity indicating acute or chronic HCV infection via HCV RNA or HCV antibody testing; active hepatitis B or C; known HIV positivity or AIDS diagnosis.\n\n13\\. Received major surgery within 4 weeks before the first dose; invasive minor procedures (catheter placement, biopsy, bronchoscopy) within 7 days before the first dose; non-thoracic radiotherapy \\>30 Gy within 4 weeks before the first dose; thoracic radiotherapy \\>30 Gy within 24 weeks before the first dose; or palliative radiotherapy \\\u003C30 Gy within 2 weeks before the first dose.\n\n14\\. Have not fully recovered from toxicities and\u002For complications induced by any prior interventions before the first dose (i.e., residual toxicity \\> Grade 1 or not returned to baseline; fatigue and alopecia are exempted).\n\n15\\. Grade ≥2 myocardial ischemia or myocardial infarction; uncontrolled arrhythmia (QTc interval ≥450 ms for males, ≥470 ms for females); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n\n16\\. History of severe bleeding events, arterial\u002Fvenous thrombosis, or pulmonary embolism.\n\n17\\. Patients at risk of gastrointestinal perforation. 18. History of allogeneic solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n19\\. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.\n\n20\\. Known allergy, hypersensitivity or intolerance to the study drug or its excipients.\n\n21\\. Diagnosed with psychiatric disorders or substance abuse; female patients who are pregnant, breastfeeding, or planning pregnancy during the trial.\n\n22\\. Any medical condition that, in the Investigator's judgment, may harm the subject or prevent the subject from complying with study requirements and procedures.","ALL","18 Years","75 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To explore the efficacy and safety of first-line EGFR-TKI combined with Trastuzumab Rezetecan in advanced NSCLC patients harboring EGFR mutations with concomitant HER2 genomic alterations or HER2 protein expression (1+\u002F2+\u002F3+)",[26,27,28],"Lung Cancer (NSCLC)","EGFR Activating Mutation","HER2",[30],"EGFR；HER2；TKI;ADC","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":20},"2026-07-09",{"date":39,"type":20},"2029-03",{"name":41,"class":42},"Yongsheng Wang","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":68,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":51,"type":20},383,[53],"PHASE1","This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[56,28,57,58,59,60,61,62,63,64,65,66,67],"HER2 Mutation-Related Tumors","HER2-positive Breast Cancer","HER2 + Breast Cancer","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","NSCLC (Non-small Cell Lung Cancer)","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[69,70,71,72,73,74,75,76,77,78,28,79],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","RECRUITING","2026-06-02",{"date":83,"type":35},"2026-06-04",{"date":85,"type":35},"2024-03-25",{"date":87,"type":20},"2028-12",{"name":89,"class":90},"Iambic Therapeutics, Inc","INDUSTRY",53,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":108,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100579768","early-phase-1-pilot-study-of-68gaga-aby-025-imaging-in-patients-undergoing-treatment-with-her2-targeted-therapy-100579768","NCT06828588","Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment.\n3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type.\n4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver.\n5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study.\n\nExclusion Criteria:\n\n1. Measurable sites of disease only in the liver.\n2. Inability to comply with study procedures.\n3. Hypersensitivity or allergy to any component of \\[68Ga\\]Ga-ABY-025.\n4. Pregnant or breastfeeding.\n5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy.\n6. Inability to lie flat for 30 minutes during an imaging session.\n7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.",{"count":99,"type":20},30,[101],"EARLY_PHASE1","The purpose of this study is to determine if the radiotracer, \\[68Ga\\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.",[104,105,28,106,107],"Locally Advanced Cancer","Metastatic Cancer","HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma","HER 2 Low-expressing Breast Cancer",[28,109,110,111,112,113,114,115,116,117,118,119,120,121],"cancer","advanced cancer","metastatic","IHC","FISH","trastuzumab","T-DM1","Pertuzumab","Margetuximab","Neratinib","Lapatinib","Tucatinib","Everolimus","2026-05-06",{"date":124,"type":35},"2026-05-08",{"date":126,"type":35},"2026-04-16",{"date":128,"type":20},"2029-12",{"name":130,"class":42},"Vanderbilt-Ingram Cancer Center",1,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":131},"100631851","phase-2-trastuzumab-in-combination-with-serplulimab-and-chemotherapy-for-the-treatment-of-her2-overexpressing-unresectable-locally-advanced-or-metastatic-biliary-tract-cancer-or-urothelial-carcinoma-after-failure-of-standard-therapy-100631851","NCT07506057","Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy","An Open-label, Single-arm Phase II Clinical Study of Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy","SHIELD","Inclusion Criteria:\n\n* Age 18 to 75 years, male or female.\n* Histologically or cytologically confirmed recurrent and\u002For metastatic advanced biliary tract cancer or urothelial carcinoma.\n* Disease progression after at least one prior line of systemic antitumor therapy. For patients who received systemic antitumor therapy during adjuvant therapy or concurrent chemoradiotherapy, progression occurring within 6 months after completion of therapy is considered as one prior line of therapy.\n* HER2 overexpression confirmed by immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH)+.\n* Left ventricular ejection fraction (LVEF) ≥ 50%.\n* No prior anti-HER2 therapy.\n* At least one measurable lesion according to RECIST version 1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Adequate organ reserve function:\n* Urine protein ≤ 1+ on urinalysis or 24-hour urine protein \\\u003C 1.0 g, and albumin \\> 2.7 g\u002FdL.\n* Life expectancy ≥ 3 months as judged by the investigator.\n* Ability to provide written informed consent and understand and agree to comply with study requirements and assessment schedule.\n* Female patients of childbearing potential must agree to use highly effective contraception during the treatment period and for 12 weeks after the last dose; male patients must agree to use highly effective contraception during the treatment period and for 6 months after the last dose.\n\nExclusion Criteria:\n\n* Known HER2-negative or HER2-low expression.\n* Active autoimmune disease or history of autoimmune disease with potential for relapse. Patients with the following conditions are not excluded and may proceed to further screening\n* Presence of other malignancies within the past 2 years or currently, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta, Tis, and T1).\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (at least once per month) within 14 days prior to enrollment.\n* Weight loss ≥ 20% within 2 months prior to enrollment.\n* Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA \\> 500 IU\u002FmL, or patients positive for HCV RNA. Patients with inactive HBsAg carriers, those with hepatitis B who have been treated and are stable (HBV DNA \\\u003C 500 IU\u002FmL), and those who have been cured of hepatitis C may be enrolled.\n* Known allergy to any study drug or excipient.\n* Palliative radiotherapy within 14 days prior to enrollment.\n* Prior anti-HER2 therapy.\n* Major surgery within 28 days prior to enrollment, except for minimally invasive procedures such as peripherally inserted central catheter (PICC) placement.\n\nMajor surgery within 28 days prior to enrollment, except for minimally invasive procedures such as peripherally inserted central catheter (PICC) placement.\n\n* Any underlying medical condition, or alcohol\u002Fdrug abuse or dependence, that in the investigator's opinion would interfere with study drug administration or affect the interpretation of drug toxicity or adverse events.\n* Concurrent participation in another therapeutic clinical study.","85 Years",{"count":142,"type":20},20,[23],"his single-center phase II clinical study enrolls patients with unresectable locally advanced or metastatic HER2-overexpressing biliary tract cancer or urothelial carcinoma who have failed standard treatment. Participants receive trastuzumab in combination with serplulimab and chemotherapy. The study aims to evaluate the efficacy and safety of this regimen in this patient population. The primary endpoint is objective response rate (ORR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), and safety.",[146,147,28],"Urothelial Carcinoma","Biliary Tract Cancer","2026-03-26",{"date":150,"type":35},"2026-04-01",{"date":152,"type":35},"2025-07-15",{"date":154,"type":20},"2029-07",{"name":156,"class":42},"Xiujuan Qu",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100620355","observational-prospective-multi-centric-study-exploring-her2-mutations-incidence-and-therapeutic-management-in-ansclc-100620355","NCT07356544","Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC","HER2 in Advanced NSCLC: an Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in Italy. The HEROS Study - GOIRC-01-2022","HEROS","Inclusion Criteria:\n\nCohort 1 (Prevalence study population)\n\n1. Male or female, aged at least 18 years.\n2. Pathologically confirmed diagnosis of NSCLC from September 2024 to September 2025.\n3. Locally advanced (IIIC), not amenable to multimodal approach (chemo-radiotherapy), or metastatic (IV) NSCLC according to TNM VIII edition.\n4. Enrolled in ATLAS project. Cohort 2 (HER2 mutations study population)\n5. Included in Cohort 1.\n6. Presence of HER2 mutation.\n7. Enrolled in ATLAS project. Cohort 3 (Prospective Biomarker Analysis population)\n8. Included in Cohort 2.\n9. Availability of tissue sample from the first 50 patients enrolled in cohort 2.\n10. Written informed consent (HEROS project) must be obtained before any study-related procedure.\n\nExclusion Criteria:\n\n\\-",{"count":166,"type":20},50,"OBSERVATIONAL","The HEROS study is an Italian observational multicenter prospective study aimed to investigate the current diagnostic and therapeutical approach towards HER2 mutated NSCLC in clinical practice. The enrolment will start in September 2024 until September 2025. A 12-months follow-up window will be performed.",[170,28],"NSCLC (Advanced Non-small Cell Lung Cancer)",[172],"HER2 mutated","2026-03-04",{"date":175,"type":35},"2026-03-05",{"date":177,"type":35},"2025-08-12",{"date":179,"type":20},"2027-01-31",{"name":181,"class":42},"Gruppo Oncologico Italiano di Ricerca Clinica",22,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":200,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100620741","phase-1-a-study-of-a-selective-erbb2-inhibitor-cgt4255-in-patients-with-advanced-solid-tumors-100620741","NCT07361562","A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors","A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression","Inclusion Criteria:\n\n1. Have histologically confirmed diagnosis of:\n\n   1. Part A: Locally advanced, metastatic, and\u002For unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and\u002For tumor or HER2 overexpression in tumor\n   2. Part B: Locally advanced, metastatic, and\u002For unresectable NSCLC with documented ERBB2 mutation in blood and\u002For tumor\n   3. Part C: Locally advanced, metastatic and\u002For unresectable breast cancer with documented ERBB2 mutation in blood and\u002For tumor or HER overexpression in tumor\n2. Have measurable disease per RECIST v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2.\n4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.\n3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease.\n5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug.\n6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.",{"count":191,"type":20},100,[53],"This is an open-label, phase 1\u002F1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.",[195,196,197,198,199,28],"Advanced Solid Tumor, Adult","ERBB2 Altered Breast Cancer","ERBB2 Gene Amplification","HER2 Overexpression","Non-Small Cell Lung Cancer",[201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,28],"ERBB2 genetic alterations","Investigational Drug","Advanced Solid Tumors","ERBB2 Mutated Non Small Cell Lung Cancer","Mutated Advanced Solid Tumors","ERBB2 Brain Metastases","ERRB2 Point Mutations","ERBB2 Gene Short Variants","ERBB2 Gene Rearrangements","ERBB2 activation alteration","ERBB2 gene copy number amplifications","ERBB2 gene insertions","ERRB2 gene deletions","ERBB2 gene fusions","NRG1 gene fusions","ERBB2 indel","Phase 1\u002F1b","HER2 Protein Overexpression","2026-02-25",{"date":221,"type":35},"2026-02-27",{"date":223,"type":35},"2025-12-30",{"date":225,"type":20},"2028-11",{"name":227,"class":90},"Cogent Biosciences, Inc.",6,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100620295","phase-2-ma-crc-ii-016-shr-1811-100620295","NCT07355764","MA-CRC-II-016 SHR-1811","SHR-1811 Combined With Bevacizumab as Second-line Treatment in Patients Metastatic CRC","Inclusion Criteria:\n\n-Provide a written informed consent form to voluntarily participate in this study.\n\nMale or female subjects aged 18-75 years.\n\n* Patients with histologically or cytologically confirmed recurrent or metastatic colorectal adenocarcinoma that is not amenable to curative resection.\n* Patients who have experienced disease progression following first-line standard therapy with oxaliplatin combined with fluoropyrimidine-based drugs.\n* Patients with disease progression within 12 months after completion of neoadjuvant or adjuvant therapy are eligible for inclusion.\n* Patients who have previously received irinotecan as part of first-line therapy may be included if investigators from the leading center determine through discussion that the patient is likely to benefit from treatment in the control group.\n* HER2 expression status: Includes patients with HER2 overexpression (IHC 3+ \u002F IHC 2+ with FISH positivity) or HER2 low-to-moderate expression (IHC 2+ with FISH negativity or IHC 1+).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.\n* Ability to provide a report documenting RAS\u002FBRAF gene status.\n* Expected survival time of at least 6 months.\n* Presence of radiologically assessed measurable lesions at baseline (per RECIST 1.1 criteria). Measurable lesions should not have received prior local therapy such as radiotherapy. Lesions located within previously irradiated areas may be selected as target lesions if disease progression in these lesions is confirmed.\n* Adequate function of major organs, meeting the following requirements (administration of blood components or cell growth factors for corrective treatment is not allowed within 14 days prior to the first dose of study medication):\n* Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum albumin ≥ 30 g\u002FL Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \\> 60 mL\u002Fmin (calculated by the Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) and International Normalized Ratio (INR) ≤ 1.5 × ULN. Patients receiving stable-dose anticoagulant therapy (e.g., low-molecular-weight heparin or warfarin) with INR within the expected therapeutic range for anticoagulants are eligible for screening.\n* For female subjects of childbearing potential:\n\nA negative serum pregnancy test result is required within 3 days prior to the first dose, and the subject must not be breastfeeding.\n\nMust agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\n-For male subjects whose partners are of childbearing potential: The subject must have undergone surgical sterilization, or agree to use effective contraceptive measures during the study period and for at least 7 months after the last dose of SHR-A1811, or for at least 6 months after the last dose of other study medications.\n\nSperm donation is prohibited during the study period.\n\nExclusion Criteria:\n\n* Toxicities from prior anti-tumor therapies have not resolved to ≤ Grade 1 per the CTCAE v5.0 criteria (except for toxicities deemed to pose no safety risk by the investigator, e.g., alopecia) or to the levels specified in the inclusion\u002Fexclusion criteria.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Subjects with a history of treated brain metastases may be enrolled provided that their brain metastases are stable, and they have not received steroid therapy for brain metastases for at least 28 days prior to study initiation. This exception does not apply to carcinomatous meningitis, as patients with carcinomatous meningitis are excluded regardless of clinical stability.\n* Known microsatellite instability-high (MSI-H) status confirmed by genetic testing or deficient mismatch repair (dMMR) status confirmed by immunohistochemistry.\n* A history of hypersensitivity to monoclonal antibodies, the formulation components of SHR-A1811, or anti-angiogenic agents.\n* Prior treatment with HER2-targeted antibody-drug conjugates (ADCs).\n* Major surgery, open biopsy, or severe trauma within 28 days prior to the first study drug administration.\n* Patients with any severe and\u002For uncontrolled diseases, including:\n\nPatients with inadequately controlled hypertension; Myocardial ischemia or myocardial infarction of Grade ≥1, cardiac arrhythmias (including QT interval ≥ 480 ms), or cardiac insufficiency of Grade ≥1; Active or uncontrolled severe infections; Hepatic diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL or 2000 IU\u002FmL) or active hepatitis C (positive for hepatitis C antibody with HCV-RNA level above the lower limit of quantification of the assay); Subjects with urine protein ≥ ++ on routine urinalysis and confirmed 24-hour urine protein quantification \\> 1.0 g.\n\n* Clinically significant bleeding symptoms or confirmed bleeding diathesis (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, or vasculitis) within 3 months prior to the first study drug administration.\n* Arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction; deep vein thrombosis; pulmonary embolism) within 6 months prior to the first study drug administration. Subjects with superficial venous thrombosis may be enrolled at the investigator's discretion.\n* Presence of another concurrent progressive malignancy requiring active treatment, with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix that have undergone potential curative treatment.\n* Any other factors judged by the investigator that may force the subject to discontinue the study prematurely, including severe concurrent illnesses (including mental illnesses) requiring concomitant treatment, severely abnormal laboratory test results, family or social factors that may affect subject safety or the collection of trial data.",{"count":237,"type":20},80,[23],"A randomized, controlled, multicenter clinical study of SHR-A1811 combined with bevacizumab for the second-line treatment of metastatic colorectal cancer",[241,28,242,243],"mCRC","Targeted Therapy","Antibody-drug Conjugates",[245,241,246],"SHR-1811","second-line","2026-01-12",{"date":249,"type":35},"2026-01-21",{"date":223,"type":20},{"date":252,"type":20},"2028-01-31",{"name":254,"class":42},"Peking Union Medical College Hospital",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":261,"minAge":4,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":131},"100614926","phase-2-efficacy-and-safety-of-distamab-vedotin-combined-with-carboplatin-for-advanced-ovarian-cancer-in-the-first-line-treatment-100614926","NCT07285941","Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment","Inclusion Criteria:\n\n* Stage II-IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer confirmed by histopathological examination;\n* Received the first tumor cell debulking surgery before enrollment and achieved R0 or R1 resection;\n* HER2 expression: IHC 2+ or 3+;\n* Had not received chemotherapy before enrollment;\n* ECOG PS ≤ 2;\n* Expected survival period ≥ 3 months;\n* Adequate organ function. During the screening period, the following criteria should be met (normal values are based on the clinical trial center): Left ventricular ejection fraction ≥ 50%; Hemoglobin ≥ 9 g\u002FdL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelets ≥ 100 × 109\u002FL; Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); When there is no liver metastasis, ALT and AST ≤ 2.5 × ULN, and when there is liver metastasis, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance rate (CrCl) ≥ 50 mL\u002Fmin according to the Cockcroft-Gault formula;\n* Non-pregnant women;\n* Signed a written informed consent form before the trial.\n\nExclusion Criteria:\n\n* Within one month prior to the start of treatment, the subject had received other anti-tumor treatments (such as radiotherapy, immunotherapy);\n* The subject had central nervous system diseases or brain metastases;\n* Had previously experienced grade II or above peripheral neuropathy;\n* Had an uncontrolled serious disease that would affect the subject's ability to receive treatment according to the study protocol: such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;\n* Had a history of other malignant tumors within the past 5 years (excluding cured skin basal cell carcinoma and cervical cancer);\n* Had known allergies to the study-related drugs or their excipients or was intolerant to them;\n* Was participating in other clinical trials at the same time;\n* Subjects judged by the researcher to be unsuitable for this study.","FEMALE",{"count":142,"type":20},[23],"Ovarian cancer exhibits the highest mortality rate among gynecological malignancies. Currently, the combination of paclitaxel and carboplatin remains the standard first-line chemotherapy regimen for neoadjuvant or postoperative treatment of ovarian cancer. However, conventional paclitaxel, due to the addition of polyoxyethylated castor oil solubilizer, may induce various adverse reactions beyond chemotherapeutic toxicity, such as hypersensitivity, toxic renal injury, neurotoxicity, and cardiovascular toxicity. Therefore, exploring optimized treatment regimens to provide patients with new therapeutic options is imperative.\n\nHER2 is a protein encoded by the ERBB2 gene that regulates cell survival, proliferation, and differentiation. HER2 gene amplification and\u002For protein overexpression are observed in 18%-35% of mucinous ovarian cancers. A meta-analysis involving over 5,000 ovarian cancer cases revealed that HER2 overexpression correlates with reduced overall survival (OS) and progression-free survival (PFS), suggesting its potential as a biomarker for poor prognosis.\n\nThe emergence of novel antibody-drug conjugates (ADCs) has brought new hope for anti-HER2 therapy in ovarian cancer, such as Disitamab Vedotin (RC48). Preliminary results from the PRaG3.0 trial presented at the 2023 ASCO Annual Meeting showed an ORR of 66.7% in six HER2-expressing gynecological cancer patients treated with RC48 combined with radiotherapy and immune checkpoint inhibitors (ICIs). Updated data from the RC48-C018 study demonstrated an ORR of 36.4%, median duration of response (mDoR) of 5.52 months, mPFS of 4.37 months, and 12-month OS rate of 66% in 22 cervical cancer patients. RC48 exhibited promising efficacy and manageable safety in recurrent\u002Fmetastatic HER2-expressing (IHC 1+\u002F2+\u002F3+) cervical cancer.\n\nRegarding safety, the GOG-158 study reported pronounced hematologic toxicity with carboplatin-paclitaxel in advanced ovarian cancer: grade 3\u002F4 leukopenia (\\>50%), thrombocytopenia (\\>30%), and neutropenia (\\>80%). Conversely, a retrospective study of RC48 combined with platinum ± bevacizumab in HER2-mutated NSCLC patients showed an ORR of 71.4% with no dose reductions or discontinuations due to adverse events. Thus, RC48-platinum combinations may offer a lower-toxicity alternative. Thus the investigators designed this trial to evaluate the efficacy and safety of RC48 combined with carboplatin in HER2-expressing advanced ovarian cancer.",[266,28],"Ovarian Cancer","2025-12-02",{"date":269,"type":35},"2025-12-16",{"date":271,"type":35},"2025-01-04",{"date":252,"type":20},{"name":274,"class":42},"Zhejiang Cancer Hospital",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":167,"phases":4,"briefSummary":284,"conditions":285,"keywords":299,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":131},"100595293","radiomics-to-predict-her2-status-and-t-dxd-efficacy-in-metastatic-breast-cancer-the-radiospher2-study-100595293","NCT07030569","RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study","RADIOSPHER2","Inclusion Criteria:\n\n* Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.\n\nExclusion Criteria:\n\n* Not available imaging (CT scan and\u002For PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;\n* Unknown HER2 status;\n* Node, soft tissue or other visceral as biopsy site.",{"count":283,"type":20},500,"RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.",[286,287,288,289,290,291,292,293,294,295,28,58,296,57,297,298],"Radiomic","Radiomics","Breast Cancer Metastatic","Breast Cancer Stage IV","Breast Carcinoma","Breast Neoplasms","Breast Cancer","Breast Cancer With Bone Metastasis","Breast Cancer With Metastatic Bone Disease","Trastuzumab","HER2 Positive Breast Carcinoma","Her2\u002FNeu Positive Advanced Solid Tumors","HER2\u002FNeu-positive Breast Cancer",[287,300,301,302,303],"HER2 expression","Trastuzumab Deruxtecan","Pathomics","HER2 heterogeneity","2025-06-12",{"date":306,"type":35},"2025-06-22",{"date":308,"type":35},"2024-02-01",{"date":310,"type":20},"2027-01-01",{"name":312,"class":42},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":320,"targetDuration":322,"studyType":167,"phases":4,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100574722","a-composite-assay-for-her2-positive-early-stage-breast-cancer-management-100574722","NCT06762977","A Composite Assay for HER2-positive Early-stage Breast Cancer Management","HERCard","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Operable breast cancer (stage I-III)\n3. Any status of hormone receptor in the primary tumor, according to institutional guidelines\n4. HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH)\n5. Neoadjuvant and\u002For adjuvant therapy based on trastuzumab ± pertuzumab\n6. Written informed consent from patients\n\nExclusion Criteria:\n\n1. Patient in follow-up for less than 3 years after surgery\n2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer",{"count":321,"type":20},180,"3 Years","The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S\\*) in women with early-stage HER2-positive breast cancer. The study aims to determine whether these tools can predict event-free (EFS) and disease-free survival (DFS) in patients treated with neoadjuvant and\u002For adjuvant trastuzumab-based therapies.",[325,28],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[327,328,329,330],"HER2-positive","operable breast cancer","gene-expression based classifier","prognosis","2025-01-07",{"date":333,"type":35},"2025-01-08",{"date":335,"type":35},"2024-11-13",{"date":337,"type":20},"2026-08",{"name":312,"class":42},2,{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":347,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":131},"100512846","phase-2-rc48-combined-with-tislelizumab-for-bladder-sparing-treatment-in-nmibc-with-bcg-treatment-failure-and-her2-expression-100512846","NCT05957757","RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression","RC48 Combined With Tislelizumab for Bladder Sparing Treatment in High-risk Non-muscular Invasive Bladder Cancer (NMIBC) With BCG Treatment Failure and HER2 Expression","Inclusion Criteria:\n\n1. ≥18 years old\n2. Histologically confirmed recurrent, non-muscle invasive bladder cancer;\n\n   1. Histopathology: Patients with any variant urothelial cell carcinoma (UCC) (i.e., squamous and\u002For glandular epithelial differentiation UCC, UCC with micropapillary changes, nest variant UCC, plasmacytoid UCC, neuroendocrine UCC, and sarcomatoid UCC) were enrolled. The presence of any lymphatic infiltration (LVI) is considered evidence of high risk.\n   2. Papillary carcinoma must be a high-risk disease defined as a high grade Ta\u002FT1 lesion. In addition, subjects must have all visible tumors completely removed prior to initial administration of the study drug, as documented at baseline cystoscopy. Cytological results for high-grade urothelial carcinoma must be negative prior to initial administration of the investigational drug.\n   3. CIS does not require complete excision, but must be completely excised with coexisting papillary carcinoma prior to enrollment and documented at baseline cystoscopy. Negative urine cytology for malignant cells is not required.\n3. When BCG recurred after treatment, the presence of HER2 expression was detected by IHC in the pathology department of our hospital\n4. BCG treatment failure included no response to BCG treatment and relapse after inadequate BCG treatment\n\n   1. Subjects without response after adequate BCG treatment must meet at least one of the following criteria: 1) Persistent or recurrent simple CIS with or without recurrent Ta\u002FT1 (non-invasive papillary carcinoma\u002Ftumor invasion of subepithelial connective tissue) disease within 12 months after completion of adequate BCG treatment; 2) Recurrent high-grade Ta\u002FT1 disease occurred within 6 months after completion of adequate BCG treatment; 3) T1 high-grade disease was present at the first disease assessment after completion of a BCG induction course. Adequate BCG treatment (minimum treatment requirement) : at least 5 out of 6 full dose treatments were received during the initial induction course and at least 1 maintenance treatment within 6 months (one full dose per week and 2 out of 3 completed treatments); Or received at least 5 out of 6 full doses in the initial induction course and at least 2 out of 6 full doses in the second induction course.\n   2. Relapse after inadequate BCG treatment: Subjects must meet the following criteria: Recurrence of high-grade Ta\u002FT1 disease within 12 months of completion of BCG treatment (as defined below): Previous inadequate BCG treatment (minimum treatment requirement) included receiving at least 5 out of 6 full dose treatments during the initial induction course. Or received at least 5 out of 6 full dose treatments during the initial induction course and at least 1 maintenance treatment (once a week and 2 out of 3 completed treatments) within 6 months. One half or one third of the dose is allowed during maintenance treatment.\n5. To refuse or be unsuitable for radical cystectomy\n6. ECOG 0\\~1\n7. The major organs are functioning normally, the following criteria are met:\n\n(1) The blood routine examination criteria should meet (no blood transfusion and no treatment with granulocyte colony stimulating factor within 14 days before enrollment) : i. Absolute count of neutrophils (ANC) ≥1,000\u002Fmm3 ii. Platelet count ≥75,000\u002Fmm3 iii. Hemoglobin ≥ 8.0g \u002FdL (2) Liver function: i. Total bilirubin ≤1.5× prescribed ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels \\>1.5×ULN ii. Upper limit of normal values (ULN) ≤2.5 times of alanine Aminotransferase (ALT) and aspartate Aminotransferase (AST) Note: ≤1.5× ULN (This criterion only applies to patients who have not received anticoagulant therapy; Patients receiving anticoagulant therapy should keep anticoagulants within therapeutic limits); (3) Kidney function: The Cockcroft-Gault formula was used to determine the creatinine clearance (CrCl) \\> 30 mL\u002Fmin.\n\n8\\. Subjects (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study; 9. Fertile women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the study drug is first administered.\n\nExclusion Criteria:\n\n1. Confirmed by histology of muscular layer infiltration (T2 or higher level) bladder urothelial carcinoma.\n2. Histopathological examination revealed any bladder small cell composition, pure, pure squamous cell carcinoma or simple squamous adenocarcinoma CIS;\n3. Received other PD - 1 \u002F PD - L1 inhibitor and\u002For HER2 inhibitor;\n4. Active malignancies other than the disease being treated (i.e., disease progression within the last 24 months or requiring a change in treatment). Only the following special circumstances are allowed: i. Skin cancer that has been treated and completely cured within the last 24 months; ii. Adequately treated lobular carcinoma in situ (LCIS) and ductal CIS; iii. A history of local breast cancer and receiving antihormonal drugs or a history of local prostate cancer (N0M0) and receiving androgen blocking therapy.\n5. History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina, myocardial infarction, ventricular fibrillation, toroidal ventricular tachycardia, cardiac arrest, or known congestive New York Heart Association Class III-IV heart failure, cerebrovascular accident, or transient ischemic attack; 2) Prolonged QTc interval confirmed by ECG evaluation during screening (Fridericia; QTc \\> 480 ms); 3) Pulmonary embolism or other venous thromboembolism within the past 2 months.\n6. Pregnancy or lactation women;\n7. Known human immunodeficiency virus (HIV) infection, unless the subjects in the past six months or longer had accepted the stability of antiretroviral therapy (art), and no opportunistic infections occurred in the past 6 months, and over the past six months the CD4 count of \\> 350;\n8. Have evidence of active hepatitis B or hepatitis C infection (for example, a history of hepatitis C but hepatitis C virus polymerase chain reaction detection results and normal subjects of hepatitis B surface antigen antibody positive hepatitis B can groups);\n9. Has yet to recover from past the toxic effects of anticancer therapy (except no clinical significance of toxic effects, such as hair loss, skin discoloration, neuropathy, and hearing impairment).\n10. Wound healing delay, defined as the skin\u002Fdecubitus ulcer, chronic leg ulcer, had known gastric ulcer or incision to heal.\n11. 1 cycle day 1 major surgery within 4 weeks before (don't think TURBT belong to major surgery).\n12. Other patients assessed by the investigator as unsuitable for participation in the study.",true,{"count":142,"type":20},[23],"This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg\u002Fkg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks).\n\nSubjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue.\n\nThe study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy.\n\nSubjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.",[352,28],"Non-Muscle Invasive Bladder Cancer",[352,300,354,355],"BCG Failure","Unsuitable or refused to radical cystectomy","2023-08-29",{"date":358,"type":35},"2023-08-31",{"date":360,"type":35},"2023-08-05",{"date":362,"type":20},"2026-06-08",{"name":364,"class":42},"RenJi Hospital"]