[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-overexpression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-overexpression":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"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":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100591052","phase-1-clinical-trial-of-yh32364-in-patients-with-locally-advanced-or-metastatic-egfr-overexpressing-solid-tumors-100591052",false,"NCT06975410","Clinical Trial of YH32364 in Patients With Locally Advanced or Metastatic EGFR Overexpressing Solid Tumors","A Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32364 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Must sign an informed consent form (ICF) prior to any study specific procedures\n* ECOG performance status 0 or 1\n* Estimated life expectancy of at least 3 months\n* A woman must not be breastfeeding\n* Have at least one measurable lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline ≥10 mm in the longest diameter (except lymph nodes which must have a short axis of ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), are suitable for accurate repeated measurements.\n\n\\[Dose Escalation Only\\] Locally advanced or metastatic EGFR overexpressing solid tumor\\* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy\n\n\\* One of the following pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+) tumors.\n\n* Head and neck squamous cell carcinoma (HNSCC)\n* Non-small cell lung cancer (NSCLC): squamous cell carcinoma (SqCC)\n* Esophageal squamous cell carcinoma (ESCC)\n* Biliary tract cancer (BTC)\n* Uterine cervical cancer\n* Vulvar cancer\n* Urothelial cancer\n* Squamous cell carcinoma of other origin of tumor (e.g., skin squamous cell tumor)\n\n\\[Dose Expansion Only\\] Cohort 1: Pathologically confirmed EGFR overexpressing (IHC3+ or IHC2+), locally advanced or metastatic HNSCC other than nasopharyngeal carcinoma (NPC)\\* that is refractory or intolerable on all available standard therapy and that is considered uncurable by local therapy.\n\nExclusion Criteria:\n\n* Known uncontrolled central nervous system (CNS) metastases, spinal cord compression, and\u002For carcinomatous meningitis\n* Have history of a second primary cancer with the exception of\n\n  * curatively treated non-melanomatous skin cancer\n  * curatively treated cervical or breast carcinoma in situ, or\n  * other malignancy with no known active disease present and no treatment administered during the last 2 years\n* Have history of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA)\n* Have history of acute coronary syndromes, including myocardial infarction, coronary artery bypass graft, unstable angina, coronary angioplasty or stenting within past 24 weeks\n* Have history of (non-infectious) interstitial lung disease (ILD) or pneumonitis that required steroids, or any evidence of current ILD or pneumonitis\n* Have autoimmune disease that has required systemic treatment\n* Infection with human immunodeficiency virus (HIV)\n* Active chronic hepatitis B or chronic hepatitis C\n\n\\[Prior\u002FConcomitant Therapy\\]\n\n* Have received systemic steroid therapy\n* Previous treatment with a 4-1BB\u002FCD137-modulating agent\n* Have used a live vaccine within 4 weeks\n* Have received treatment with immunotherapy, biological therapies, targeted small molecules, or hormonal therapies\n* Have received radiation therapy\n* Have received cytotoxic chemotherapy","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a study for people with locally advanced or metastatic cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with Epidermal Growth Factor Receptor (EGFR) overexpressing can join the study. The purpose of this study is to find out whether a medicine called YH32364 helps people with locally advanced or metastatic cancers with EGFR overexpression.",[27,28,29],"EGFR Overexpression","Locally Advanced Solid Tumor","Metastatic Solid Tumor",[31,32,33,34,35,36,37,38,39,40],"YH32364","EGFR\u002F4-1BB bispecific antibody","Solid tumor","Head and neck squamous cell carcinoma (HNSCC)","Non-small cell lung cancer (NSCLC)","Esophageal squamous cell carcinoma (ESCC)","Biliary tract cancer (BTC)","Uterine cervical cancer","Vulvar cancer","Urothelial cancer","RECRUITING","2026-06-09",{"date":44,"type":45},"2026-06-10","ACTUAL",{"date":47,"type":45},"2025-06-12",{"date":49,"type":20},"2029-12",{"name":51,"class":52},"Yuhan Corporation","INDUSTRY",4,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100547957","phase-1-her-2-b-cell-peptide-vaccine-100547957","NCT06414733","HER-2 B Cell Peptide Vaccine","Phase Ib Active Immunotherapy Trial (Expansion) With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 Adjuvant in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\nInclusion Criteria for Extension and Expansion Cohorts\n\n1. For the extension cohort to be conducted at the IUSCCC (N=12), patients with histologically documented metastatic or unresectable breast or gastrointestinal cancer will be enrolled.\n2. For the expansion cohort (N=30), patients with either histologically documented metastatic or unresectable breast cancer (N=15), or histologically documented metastatic or unresectable gastrointestinal cancer (N=15) be enrolled. All patients enrolled to this cohort are required to have measurable disease. Note: Measurable disease is defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.\n\n   Inclusion Criteria for all Cohorts:\n3. Patients must have received or refused first line standard systemic therapy for their metastases (if applicable) and patients with histologically confirmed pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years after standard therapy. Patients with histologically confirmed breast, and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years after standard therapy.\n4. Progressive disease after at least one line of standard therapy.\n5. Patients with pancreatic and esophageal cancers must have received no more than two prior cytotoxic chemotherapy regimens in the last two years. Patients with breast and gastrointestinal cancers must have received no more than three prior cytotoxic chemotherapy regimens in the last two years.\n6. Patients are required to have HER-2 (IHC 1+, 2+ and 3+) or EGFR over-expression (FISH and IHC) to be enrolled on this study.\n\n   1. If the patient has had HER-2 expression measured prior to enrollment, the report alone will be accepted on the expansion phase of the study.\n   2. If the patient has had EGFR expression measured prior to enrollment, the report alone will be accepted on the dose escalation phase of the study.\n   3. If the patient has not had HER-2 or EGFR expression measured prior to enrollment on this study, it would be obligatory for the patient to have the tests performed to justify their status. HER-2 status can be performed by a variety of tests. Either IHC or FISH assay are acceptable if breast tumor tissues (previously frozen) are available. The test can be done at IUSCCC or elsewhere if the patient is from out of town.\n7. Patients with prior history of treated brain metastases who are off steroids and have stable metastatic brain disease for at least 3 months are eligible.\n8. Patients must be ambulatory with an ECOG performance status 0, 1, or 2 (appendix II).\n9. Patients must have adequate organ function as defined by:\n\n   1. ANC ≥ 1,000\u002Fmm³, platelet count \\> 700,000\u002Fmm³.\n   2. Serum bilirubin \\\u003C 1.5 mg%, regardless of whether patients have liver involvement secondary to tumor. ALT must be \\\u003C 2 times upper limit of normal.\n   3. Creatinine \\\u003C1.5 mg\u002Fdl or calculated creatinine clearance \\> 60 ml\u002Fmin\n10. Patients must be at least 3 weeks past any prior surgery, cytotoxic, chemotherapy, other immunotherapy, hormonal therapy, or radiation therapy. Patients having been treated with monoclonal antibodies may enter the trial after a specified period of time (2 times the mean half life of the agent). Patients must have recovered from any toxicity of prior therapy prior to enrolling on study except for neuropathy where patients need to recover to less than grade 2.\n\n    1. Patients with hormone receptor positive breast cancer who are on stable endocrine therapy are eligible if their tumor has some expression of HER-2 based on IHC of 1+ or 2+.\n11. Patients must be at least 18 years of age.\n12. Women of child-bearing potential must not be pregnant and must have a negative pregnancy test (Women of childbearing potential definition: (ECOG definition)).\n13. Men and women must agree to practice effective contraception while on this study.\n14. Patients must obtain a base line Echocardiogram or MUGA and require the left ventricular ejection fraction to be within normal limits (or 50% or higher).\n15. Ability to understand and the willingness to sign a written informed consent document.\n\nThe patient must be aware that his\u002Fher disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.\n\nExclusion Criteria:\n\n1. Patients with tumors that are negative for HER-2 expression based on IHC of 0 AND Fluorescence in-situ hybridization showing lack of HER-2 amplification based on most recent ASCO\u002FCAP guidelines; or are under-expressing EGFR based on FISH and IHC.\n2. Patients on targeted therapies, such as Cycline Dependent Kinase (CDK) 4\u002F6 or mammalian target of rapamycin (mTOR) inhibitors in combination with endocrine therapy\n3. Patients who are {MVF-HER-2(266-296) and MVF-HER-2 (597-626)} immediate hypersensitivity skin test positive.\n4. Patients who have evidence of active infection that requires antibiotic therapy. Patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment and must be confirmed to be clear of the infection.\n5. Patients with known active HIV, hepatitis A, hepatitis B, or hepatitis C infection.\n6. Patients with serious uncontrolled cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases. At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n7. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible.\n8. Splenectomized patients.\n9. Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome.\n\n   Note: At the discretion of the treating physician, patients who show disease control for at least 6 months may be enrolled.\n10. Patients who have developed anaphylactic responses to other vaccines",{"count":62,"type":20},42,[23],"This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.",[66,67,68,69,27],"Metastatic Breast Cancer","Metastatic Gastrointestinal Carcinoma","HER2-positive Breast Cancer","HER2-positive Gastric Cancer",[71,72,73],"Phase I","Breast Cancer","GI Cancer","2025-08-19",{"date":76,"type":45},"2025-08-24",{"date":78,"type":45},"2025-01-17",{"date":80,"type":20},"2030-12-31",{"name":82,"class":83},"Pravin T.P Kaumaya","OTHER",1]