{"id":"rad-p53-gene","safety":{"commonSideEffects":[{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Flu-like symptoms"},{"rate":null,"effect":"Transient liver enzyme elevation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This gene therapy delivers a functional copy of the p53 tumor suppressor gene via an adenoviral vector into cancer cells that have lost or mutated p53. Restoration of p53 function triggers apoptosis in malignant cells and restores cell cycle control. The approach is designed to overcome p53 deficiency, which is present in a majority of human cancers.","oneSentence":"rAd-p53 is a recombinant adenovirus carrying the wild-type p53 tumor suppressor gene that restores p53 function in cancer cells to induce apoptosis and inhibit tumor growth.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:03:45.853Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Head and neck squamous cell carcinoma"},{"name":"Lung cancer"}]},"trialDetails":[{"nctId":"NCT06159907","phase":"","title":"Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.","status":"RECRUITING","sponsor":"IRCCS San Raffaele","startDate":"2021-10-27","conditions":"Gynecological Tumors","enrollment":380},{"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":"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":"NCT01574729","phase":"PHASE2","title":"Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2012-08","conditions":"Non-small Cell Lung Cancer","enrollment":120},{"nctId":"NCT00902122","phase":"PHASE4","title":"rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2009-05","conditions":"Advanced Malignant Thyroid Tumors","enrollment":600},{"nctId":"NCT00902083","phase":"PHASE4","title":"rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2009-06","conditions":"Advanced Oral and Maxillofacial Malignant Tumors","enrollment":600},{"nctId":"NCT00894153","phase":"PHASE4","title":"p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage","status":"UNKNOWN","sponsor":"Shenzhen SiBiono GeneTech Co.,Ltd","startDate":"2009-05","conditions":"Neoplasms","enrollment":1200},{"nctId":"NCT00004080","phase":"PHASE1","title":"Gene Therapy in Treating Patients With Recurrent or Progressive Brain Tumors","status":"COMPLETED","sponsor":"National Cancer Institute (NCI)","startDate":"1999-12","conditions":"Brain and Central Nervous System Tumors","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"rAd-p53 gene","genericName":"rAd-p53 gene","companyName":"Shenzhen SiBiono GeneTech Co.,Ltd","companyId":"shenzhen-sibiono-genetech-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"The rAd-p53 gene is a form of gene therapy used to treat various conditions, including advanced malignant thyroid tumors, neoplasms, and advanced adult hepatocellular carcinoma, as per ClinicalTrials.gov. According to ChEMBL, the rAd-p53 gene is administered as a small molecule intervention.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}