[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her-2-protein-overexpression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her-2-protein-overexpression":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,97,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":38,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100569561","phase-2-a-phase-2-study-of-zanidatamab-in-patients-with-her2-expressing-tumors-100569561",false,"NCT06695845","A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors","A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)","Inclusion Criteria:\n\n1. Is at least 18 years of age inclusive at the time of signing the informed consent\n2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.\n3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.\n4. All participants must have adequate tumor sample for submission to allow central HER2 testing.\n5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Has a life expectancy of at least 3 months, in the opinion of the investigator.\n8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:\n\n   1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.\n   2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \\\u003C Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment \\> 7 days prior to Cycle 1 Day 1.\n   3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.\n9. Adequate organ functions.\n10. Females of childbearing potential must have a negative pregnancy test result.\n11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.\n\nExclusion Criteria:\n\n1. Has known or suspected leptomeningeal disease and\u002For untreated brain metastasis.\n2. Has uncontrolled or significant cardiovascular disease\n3. Has ongoing toxicity related to prior cancer therapy\n4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.\n5. Has known Human Immunodeficiency Virus (HIV) infection.\n6. Has active hepatitis B or C infection.\n7. Has an active SARS-CoV-2 infection.\n8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.\n9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.\n10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.\n11. Prior treatment with HER2-targeted therapy (Cohort 1 only).\n12. Has a history of trauma or major surgery\n13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n14. Received zanidatamab at any time prior to the current study.\n15. Colorectal Cancer (CRC) participants with known KRAS\u002FNRAS and BRAF mutations.\n16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.\n17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.\n18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.",[26,27,28,29,30,31,32,33,34,35,36,37],"Breast Cancer","Gastric Cancer","Esophageal Cancer","Gastroesophageal Cancer","Colorectal Cancer","Endometrial Cancer","Non-small Cell Lung Cancer","Ovarian Cancer","Urothelial Carcinoma","Salivary Gland Cancer","Pancreatic Cancer","HER-2 Protein Overexpression",[39,40,41],"JZP598","ZW25","HER2 IHC 3+ Overexpression Solid Tumors","RECRUITING","2026-06-05",{"date":45,"type":46},"2026-06-09","ACTUAL",{"date":48,"type":46},"2025-01-14",{"date":50,"type":20},"2027-12-31",{"name":52,"class":53},"Jazz Pharmaceuticals","INDUSTRY",28,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":77,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100438877","phase-1-her2-chimeric-antigen-receptor-car-t-cells-in-combination-with-checkpoint-blockade-in-patients-with-advanced-sarcoma-100438877","NCT04995003","HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma","Phase I Study of HER2 Chimeric Antigen Receptor (CAR) T Cells in Combination With Checkpoint Blockade in Patients With Advanced Sarcoma (HEROS 3.0)","Procurement Inclusion Criteria:\n\n* Diagnosis of a HER2-positive sarcoma. Immunohistochemistry (IHC) will be used to determine HER2 expression. Standard HER2 positive breast cancer density gradient tissue microarrays will be used as positive controls. HER2 expression will be graded for percent positive tumor cells (Grade 0: no staining; Grade 1: 1-25%; Grade 2: 26-50% and Grade 3: 51-100%) and intensity of staining (Negative; 1+; 2+; and 3+). For the patient to meet eligibility, tumors are required to have at least ≥ grade 1 and ≥ 1+ intensity score for HER2 staining.\n* Age between 1 to 25 years\n* Karnofsky or Lansky performance score of ≥ 60\n* Informed consent explained to, understood by, and signed by patient\u002Fguardian. Patient or guardian given copy of informed consent.\n\nTreatment Inclusion Criteria:\n\n* Diagnosis of a HER2 positive sarcoma with active disease progression or recurrence after at least one prior systemic therapy\n* At least 4 weeks from and having recovered from acute toxic effects of all prior cytotoxic chemotherapy. Those receiving targeted (non-cytotoxic) drugs must be at least 7 days or 3 drug half-lives, whichever is greater, from last receipt of said drug and must have recovered from all acute toxic effects of that drug.\n* Normal cardiac left ventricular end diastolic function (LVEF) as measured by echocardiogram (normal per institutional limits)\n* Karnofsky or Lansky performance score of ≥60\n* Total bilirubin ≤1.5x upper limit of normal (ULN) for age AND direct bilirubin ≤ULN for age\n* AST\u002FALT ≤ 2.5x ULN\n* Serum creatinine ≤1.5x ULN for age\n* Hgb ≥ 7.0 g\u002FdL (transfusion allowed)\n* WBC \\> 2,000\u002Fµl\n* ANC \\>1,000\u002Ful\n* Platelets \\>75,000\u002Ful (not transfused)\n* Pulse oximetry of ≥ 90% on room air\n* Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. Non-childbearing potential is defined as pre-menarche, greater than 1-year post-menopausal, or surgically sterilized.\n* Available autologous transduced cytotoxic T lymphocytes with ≥ 15% expression of HER2 CAR and killing of HER2-positive targets ≥ 20% in cytotoxicity assay\n* Informed consent explained to, understood by, and signed by patient or guardian. Patient or guardian given copy of informed consent.\n\nProcurement Exclusion Criteria:\n\n* Known HIV positivity\n* Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic reaction, or grade 4 hemorrhagic cystitis\n* Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of hemolytic anemia, or development of a secondary malignancy\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients\n* History of allergic reactions attributed to murine protein containing products, DMSO or dextran 40\n* Known, active cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York Heart Association (NYHA) functional class III or IV or clinically significant cardiac arrhythmia.\n\nNote: A new echocardiogram or EKG is not required to make this determination.\n\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* History of non-infectious pneumonitis that required steroids or current pneumonitis\n* Known history of active tuberculosis\n* Has undergone solid organ transplantation at any time\n* Has a diagnosis of immunodeficiency or is receiving any other form of immunosuppressive therapy aside from cytotoxic chemotherapy\n* Presence of bulky tumor at the primary or metastatic site\n* Has a history or current evidence of any condition, therapy, or laboratory or radiologic abnormality that is not in the best interest of the subject to participate, as determined by the treating investigator\n\nTreatment Exclusion Criteria:\n\n* Known HIV positivity\n* Intercurrent infection\n* Pregnant or lactating\n* History of hypersensitivity to murine protein-containing products, DMSO or dextran 40\n* Severe previous toxicity from cyclophosphamide including, but not limited to, decreased heart function, abnormal heart rhythms, severe allergic reaction, or grade 4 hemorrhagic cystitis\n* Severe previous toxicity from fludarabine including, but not limited to, neurotoxicity, coma, renal injury requiring dialysis, development of hemolytic anemia, or development of a secondary malignancy\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab or nivolumab or any of their excipients\n* Cardiac disorder defined as left ventricular ejection fraction below the institution normal as determined by echocardiogram or New York Heart Association (NYHA) functional class III or IV or clinically significant cardiac arrhythmia\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of non-infectious pneumonitis that required steroids or current pneumonitis\n* Known history of active tuberculosis\n* Has received a live virus vaccine within previous 30 days\n* Has undergone solid organ transplantation at any time\n* Has a diagnosis of immunodeficiency or is receiving any other form of immunosuppressive therapy\n* Presence of bulky tumor at the primary or metastatic site\n* Has received radiotherapy within 14 days of start of trial treatment with the exception that those who have received palliative radiation (≤ 10 days of radiotherapy) to non-central nervous system disease within 7 days are permitted. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has a history or current evidence of any condition, therapy, or laboratory or radiologic abnormality that is not in the best interest of the subject to participate, as determined by the treating investigator","1 Year","25 Years",{"count":65,"type":20},25,[67],"PHASE1","The purpose of this study is to learn whether it is safe to give HER2-CAR T cells in combination with an immune checkpoint inhibitor drug (pembrolizumab or nivolumab), to learn what the side effects are, and to see whether this therapy might help patients with sarcoma.\n\nAnother goal of this study is to study the bacteria found in the stool of patients with sarcoma who are being treated with HER2 CAR T cells and immune checkpoint inhibitor drugs to see if the types of bacteria influence how well the treatment works.\n\nThe investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. They now want to see if they can put a new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new gene that the investigators will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor Receptor 2) that binds to sarcoma cells. In addition, it contains CD28, which stimulated T cells and make them last longer. After this new gene is put into the T cell, the T cell becomes known as a chimeric antigen receptor T cell or CAR T cell.\n\nIn another clinical study using these CAR T cells targeting HER2 as well as other studies using CAR T cells, investigators found that giving chemotherapy before the T cell infusion can improve the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of the patient's lymphocytes first should allow the infused T cells to expand in the body, and potentially kill cancer cells more effectively.\n\nThe chemotherapy used for lymphodepletion is a combination of cyclophosphamide and fludarabine.\n\nAfter the patient receives the lymphodepletion chemotherapy and CAR T cells during treatment on the study, they will receive an antibody drug called an immune checkpoint inhibitor, pembrolizumab or nivolumab. Immune checkpoint inhibitors are drugs that remove the brakes on the immune system to allow it to act against cancer.",[70,37,71,72,73,74,75,76],"Sarcoma","Osteosarcoma","Rhabdomyosarcoma","Ewing Sarcoma","Synovial Sarcoma","Soft Tissue Sarcoma","Undifferentiated Sarcoma",[70,78,79,80,81,71,72,82,83,84,85],"Her-2 Positive Sarcoma","autologous T cells","HER2 positive recurrent or progressive sarcoma","HER2 CAR T cells","Ewing sarcoma","Synovial sarcoma","Soft tissue sarcoma","Undifferentiated sarcoma","2026-01-21",{"date":88,"type":46},"2026-01-22",{"date":90,"type":46},"2021-12-07",{"date":92,"type":20},"2043-06-30",{"name":94,"class":95},"Baylor College of Medicine","OTHER",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":130,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen",{"count":106,"type":20},124,[67],"I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[110,111,112,113,114,115,37,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic Breast Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER2-negative Breast Cancer","Triple Negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":167,"type":46},"2025-04-04",{"date":169,"type":46},"2023-02-15",{"date":171,"type":20},"2029-12-30",{"name":173,"class":95},"QuantumLeap Healthcare Collaborative",7,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":96},"100530494","phase-2-disitamab-vedotin-combined-with-bcg-therapy-in-her2-expressing-high-risk-non-muscle-invasive-bladder-cancer-100530494","NCT06187506","Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer","A Prospective, Open, Single-center Clinical Study of Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n1. Age≥18 years;\n2. Histologically confirmed non-muscle-invasive urothelial cell carcinoma (UCC) of the bladder; A.Histopathology: any variant of UCC, The presence of any lymphovascular infiltration (LVI) was considered evidence of high risk. B. Confined to the mucosal (Ta, Tis) and lamina propria layers (T1) of the bladder. In addition, subjects had all visible tumors removed as completely as possible prior to the first dose of study drug and documented at baseline cystoscopy. C. CIS(Carcinoma in situ) does not require complete resection, but coexisting papillary carcinoma must be removed as completely as possible prior to enrollment and documented at baseline cystoscopy. Negative urine cytology results against malignant tumor cells are not required.\n3. Presence of HER2 expression (IHC 1+\u002F2+\u002F3+) by IHC in our pathology department;\n4. VHR(Very high risk) NMIBC, defined as having at least 1 of the following: Multiple and\u002For large (greater than \\[\\>\\] 3 centimeters \\[cm\\]) T1, (HG\u002FG3) tumors; T1, (HG\u002FG3) tumor with concurrent CIS; T1, G3 with CIS in prostatic urethra; Micropapillary variant of non-muscle invasive urothelial carcinoma;\n5. Received first dose of medication ≤ 12 weeks from first TURBT;\n6. Refusal or unsuitability for radical cystectomy;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\\\u003C\u002F=) 1;\n8. Adequate hematologic and end-organ function, Creatinine clearance \\>\u002F=30 milliliters per minute (mL\u002Fmin) (calculated using the Cockcroft-Gault formula);\n9. Subjects (or their legal representatives) must sign an informed consent form (ICF);\n10. Females of childbearing potential must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days prior to the first dose of study drug.\n\nExclusion Criteria:\n\n1. Evidence of locally advanced, metastatic, muscle-invasive, and\u002For extravesical bladder cancer;\n2. Upper urinary tract urothelial carcinoma(UTIC), except 2 years without recurrence after previous radical UTUC;\n3. Histopathologic examination reveals any small cell component of the bladder, simple adenocarcinoma, simple squamous cell carcinoma or simple squamous CIS;\n4. Previously received other anti-HER-2 therapy;\n5. Active malignancy outside of the disease being treated by the study (i.e., disease progression or need for change in therapy within the past 24 months);Only the following special cases are allowed: a. Skin cancer treated within the last 24 months and completely cured; b. Adequately treated lobular carcinoma in situ (LCIS) and ductal CIS; c. History of localized breast cancer and receiving anti-hormonal drugs or history of localized prostate cancer (N0M0) and receiving androgen blockade therapy.\n6. History of uncontrolled cardiovascular disease, Included: 1) presence of any of the following in the past 3 months: unstable angina, myocardial infarction, ventricular fibrillation, torsional 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 intervals confirmed by ECG evaluation during screening(Fridericia; QTc\\>480 ms). 3) Pulmonary embolism or other venous thromboembolism within the past 2 months.\n7. Pregnant or lactating women;\n8. Known infection with human immunodeficiency virus (HIV), unless the subject has been on stable antiretroviral therapy for the past 6 months or longer and has not had an opportunistic infection in the past 6 months and has had a CD4 count \\>350 in the past 6 months;\n9. Evidence of active hepatitis B or C infection (e.g., subjects with hepatitis B who have a history of hepatitis C but have a normal polymerase chain reaction test result for hepatitis C virus and who are positive for antibodies to hepatitis B surface antigen may be enrolled in the study);\n10. Have not recovered from toxic effects of previous anticancer therapy (except for toxic effects of no clinical significance, such as alopecia, skin discoloration, neuropathy and hearing impairment).\n11. Delayed wound healing, defined as skin\u002Fdecubitus ulcers, chronic leg ulcers, known gastric ulcers, or non-healing incisions;\n12. Major surgery within 4 weeks prior to day 1 of cycle 1 (TURBT not considered major surgery);\n13. Other patients assessed by the investigator to be unsuitable for participation in this study.",{"count":183,"type":20},20,[23],"This is a prospective, open, single-center clinical study of the anti-HER2(Human epidermal growth factor receptor-2) ADC(antibody-drug conjugate) drug Disitamab Vedotin in combination with BCG(bacillus Calmette-Guerin) therapy in very high-risk NMIBC(Non-muscle invasive bladder cancer) patients with HER2 expression (IHC 1+\u002F2+\u002F3+), which is being conducted in accordance with the Good Clinical Practice for Pharmaceutical Trials (GCP). Approximately 20 subjects will be enrolled in this study to evaluate the efficacy and safety of Disitamab Vedotin (2.0 mg\u002Fkg, administered intravenously every three weeks) in combination with BCG therapy.",[187,37],"Non-muscle Invasive Bladder Cancer","2024-07-11",{"date":190,"type":46},"2024-07-12",{"date":192,"type":46},"2023-12-18",{"date":194,"type":20},"2027-01",{"name":196,"class":95},"Fudan University"]