{"id":"p53-gene-therapy","safety":{"commonSideEffects":[{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Local injection site reactions"},{"rate":null,"effect":"Flu-like symptoms"},{"rate":null,"effect":"Transient elevation of liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL4298181","moleculeType":"Gene"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"p53 is a critical tumor suppressor gene that is frequently mutated or lost in cancers, allowing malignant cells to evade apoptosis and proliferate uncontrollably. This therapy uses an adenoviral vector to introduce wild-type p53 gene directly into tumor tissue, restoring the ability of cancer cells to undergo programmed cell death and halt proliferation. By restoring p53 function, the therapy aims to trigger tumor regression and improve survival in p53-deficient cancers.","oneSentence":"This gene therapy delivers functional p53 tumor suppressor gene into cancer cells to restore apoptosis and cell cycle arrest.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:59:29.354Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Head and neck squamous cell carcinoma"},{"name":"Lung cancer"}]},"trialDetails":[{"nctId":"NCT07424560","phase":"","title":"Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer","status":"RECRUITING","sponsor":"Zhilong Dong","startDate":"2026-02-25","conditions":"Bladder Cancer, Bladder Cancer Recurrence, Adjuvant Therapy for Bladder Cancer","enrollment":400},{"nctId":"NCT07222215","phase":"PHASE2","title":"PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)","status":"RECRUITING","sponsor":"Kristina A. Fanucci","startDate":"2026-01-16","conditions":"Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer, Breast Cancer","enrollment":297},{"nctId":"NCT07302932","phase":"NA","title":"Metformin and Molecular Aging in Prediabetes","status":"COMPLETED","sponsor":"Diabetes Foundation, India","startDate":"2023-02-01","conditions":"Metformin, Prediabetes","enrollment":112},{"nctId":"NCT03217266","phase":"PHASE1","title":"Navtemadlin and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"2018-06-20","conditions":"Resectable Soft Tissue Sarcoma, Soft Tissue Sarcoma","enrollment":39},{"nctId":"NCT07150416","phase":"PHASE2","title":"Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study","status":"NOT_YET_RECRUITING","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","startDate":"2025-10-01","conditions":"Multiple Pulmonary Ground-Glass Nodules, Lung Neoplasms, Precancerous Conditions","enrollment":38},{"nctId":"NCT02340117","phase":"PHASE2","title":"Study of Combined SGT-53 Plus Gemcitabine/Nab-Paclitaxel for Metastatic Pancreatic Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"SynerGene Therapeutics, Inc.","startDate":"2015-01","conditions":"Metastatic Pancreatic Cancer","enrollment":28},{"nctId":"NCT00898755","phase":"","title":"Collecting and Storing Tissue From Young Patients With Cancer","status":"COMPLETED","sponsor":"Children's Oncology Group","startDate":"2007-03-05","conditions":"Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Central Nervous System Neoplasm","enrollment":213},{"nctId":"NCT04277442","phase":"PHASE1","title":"Testing Nivolumab in Combination With Decitabine and Venetoclax in Patients With Newly Diagnosed TP53 Gene Mutated Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"National Cancer 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Lymphoma","enrollment":96},{"nctId":"NCT02980731","phase":"PHASE3","title":"A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).","status":"COMPLETED","sponsor":"AbbVie","startDate":"2016-12-13","conditions":"Chronic Lymphocytic Leukemia (CLL)","enrollment":210},{"nctId":"NCT00280761","phase":"","title":"Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy","status":"COMPLETED","sponsor":"UNC Lineberger Comprehensive Cancer Center","startDate":"2003-12","conditions":"Colorectal Cancer","enrollment":47},{"nctId":"NCT02090114","phase":"PHASE2","title":"RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2014-08-25","conditions":"Prostate Cancer","enrollment":112},{"nctId":"NCT02340156","phase":"PHASE2","title":"Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma","status":"TERMINATED","sponsor":"SynerGene Therapeutics, Inc.","startDate":"2014-12","conditions":"RECURRENT GLIOBLASTOMA","enrollment":1},{"nctId":"NCT00003450","phase":"PHASE1","title":"Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"1998-09","conditions":"Ovarian Cancer, Peritoneal Cavity Cancer","enrollment":""},{"nctId":"NCT03149679","phase":"PHASE2","title":"The p53 Colorectal Cancer Trial","status":"TERMINATED","sponsor":"Haukeland University Hospital","startDate":"2017-05-09","conditions":"Colorectal Cancer Metastatic, Colorectal Cancer Stage IV, TP53 Gene 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Lee Moffitt Cancer Center and Research Institute","startDate":"2007-10-02","conditions":"Small Cell Lung Cancer","enrollment":69},{"nctId":"NCT00004041","phase":"PHASE1","title":"Gene Therapy in Treating Patients With Recurrent Malignant Gliomas","status":"COMPLETED","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"1999-02-25","conditions":"Brain and Central Nervous System Tumors","enrollment":""},{"nctId":"NCT00686842","phase":"PHASE1, PHASE2","title":"PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma","status":"TERMINATED","sponsor":"AIDS Malignancy Consortium","startDate":"2008-09","conditions":"Kaposi's Sarcoma","enrollment":17},{"nctId":"NCT00897663","phase":"","title":"Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies","status":"COMPLETED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2006-11","conditions":"Brain and Central Nervous System Tumors","enrollment":56},{"nctId":"NCT01029873","phase":"PHASE1, PHASE2","title":"QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma","status":"COMPLETED","sponsor":"Altor BioScience","startDate":"2010-02","conditions":"Metastatic Melanoma","enrollment":25},{"nctId":"NCT02941003","phase":"NA","title":"Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer","status":"UNKNOWN","sponsor":"Shanghai Chest Hospital","startDate":"2016-02","conditions":"Lung Cancer","enrollment":540},{"nctId":"NCT01212380","phase":"PHASE1","title":"Study of Carfilzomib in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) or Prolymphocytic Leukemia (PLL)","status":"COMPLETED","sponsor":"Ohio State University Comprehensive Cancer Center","startDate":"2010-10","conditions":"B-cell Chronic Lymphocytic Leukemia, Hematopoietic/Lymphoid Cancer, Prolymphocytic Leukemia","enrollment":21},{"nctId":"NCT00704938","phase":"PHASE2","title":"Gene-Modified Lymphocytes, High-Dose Aldesleukin, and Vaccine Therapy in Treating Patients With Progressive or Recurrent Metastatic Cancer","status":"TERMINATED","sponsor":"National Institutes of Health Clinical Center (CC)","startDate":"2008-06","conditions":"Kidney Cancer, Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific","enrollment":3},{"nctId":"NCT02561546","phase":"PHASE2","title":"p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2015-12","conditions":"HCC, Diabetes","enrollment":40},{"nctId":"NCT02509169","phase":"PHASE2","title":"Trans-catheter Arterial Embolization Combined With p53 Gene Therapy for Treatment of Advanced Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2014-10","conditions":"Advanced Hepatocellular Carcinoma (HCC)","enrollment":60},{"nctId":"NCT00423865","phase":"PHASE1","title":"Cisplatin and Everolimus in Treating Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2006-11","conditions":"Unspecified Adult Solid Tumor, Protocol Specific","enrollment":30},{"nctId":"NCT02435186","phase":"PHASE2","title":"p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2015-06","conditions":"Ovarian Epithelial Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer","enrollment":100},{"nctId":"NCT02429726","phase":"PHASE2","title":"Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2015-06","conditions":"Malignant Pleural Effusion","enrollment":90},{"nctId":"NCT02429037","phase":"PHASE2","title":"P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2015-05","conditions":"Advanced Head and Neck Cancer","enrollment":60},{"nctId":"NCT02418988","phase":"PHASE2","title":"Trans-catheter Chemo-embolization Combined With rAd-p53 Gene Injection in Treatment of Advanced Hepatocellular Carcinoma","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2014-07","conditions":"Advanced Adult Hepatocellular Carcinoma","enrollment":120},{"nctId":"NCT00049218","phase":"PHASE1, PHASE2","title":"Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer","status":"COMPLETED","sponsor":"H. 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Used for Head and neck squamous cell carcinoma, Lung cancer.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}