{"id":"abivertinib","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03053219","NCT03574402","NCT02448251","NCT03001609","NCT04528667","NCT03058094","NCT03856697","NCT03300115","NCT05361915","NCT04440007","NCT02274337","NCT03060850","NCT02330367"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2017","type":"neutral","milestone":"Phase 1 Initiated","description":"Study to Investigate the Absorption, Metabolism and Excretion of [14C] AC0010 in Patients With Advan — Carcinoma, Non-Small-Cell Lung"},{"date":"2017","type":"neutral","milestone":"Phase 2 Initiated","description":"Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Advanced Non Small Cell — Non-Small Cell Lung Cancer"},{"date":"2019","type":"neutral","milestone":"Phase 3 Initiated","description":"A Study Comparing AC0010 and Chemotherapy in Patients With Advanced NSCLC Who Have Progressed Follow — NSCLC"}],"aiSummary":"Abivertinib is a drug being studied in combination with abiraterone for metastatic castration-resistant prostate cancer, and also for safety and efficacy in hospitalized patients. Clinical trials are also investigating its absorption, metabolism, and excretion. It is being studied as STI-5656 (Abivertinib Maleate).","brandName":"ABIVERTINIB","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"","explanation":"Abivertinib is being investigated in clinical trials to understand how it works in the body and whether it can help treat certain conditions. Studies are looking at how the drug is absorbed, broken down, and removed from the body. These trials also assess the drug's safety and how well it works in patients with specific illnesses.","oneSentence":"Abivertinib is being studied in trials for prostate cancer and in hospitalized patients to assess its safety and how the body processes it.","technicalDetail":"Abivertinib is being studied in trials for metastatic castration-resistant prostate cancer. A Phase 1 study investigates the absorption, metabolism and excretion of [14C] AC0010. A Phase 2 study assesses the safety and efficacy of STI-5656 (Abivertinib Maleate) in hospitalized subjects."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ABIVERTINIB","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03053219","phase":"Phase 1","title":"An Open-Label, Non-Randomized, Single-Center Study to Preliminary Evaluation of Safety and Efficacy of Patients Who Participant in [14C] AC0010 Trail and Subsequent Receiving AC0010 Treatment","status":"COMPLETED","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":false,"enrollment":7,"indication":"Carcinoma，Non-Small-Cell Lung","completionDate":"2018-12"},{"nctId":"NCT03574402","phase":"Phase 2","title":"An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP","status":"UNKNOWN","sponsor":"Guangdong Association of Clinical Trials","isPivotal":false,"enrollment":400,"indication":"Carcinoma, Non-Small-Cell Lung","completionDate":"2024-12-30"},{"nctId":"NCT02448251","phase":"Phase 1","title":"A Phase I, Multicenter, Open-Label Safety, Pharmacokinetic and Preliminary Efficacy Study of Wild-type Sparing EGFR Inhibitor, AC0010MA, in Adult Patients With Previously Treated EGFRmut and Acquired ","status":"TERMINATED","sponsor":"ACEA Therapeutics, Inc.","isPivotal":false,"enrollment":28,"indication":"Non Small Cell Lung Cancer","completionDate":"2019-10"},{"nctId":"NCT03001609","phase":"Phase 1","title":"An Open-Label, Non-Randomized, Single-Center Study to Determine the Absorption, Metabolism and Excretion of A Single Dose [14C] AC0010 in Patients With Advanced NSCLC","status":"COMPLETED","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":false,"enrollment":7,"indication":"Carcinoma, Non-Small-Cell Lung","completionDate":"2017-09"},{"nctId":"NCT04528667","phase":"Phase 2","title":"A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19","status":"COMPLETED","sponsor":"Sorrento Therapeutics, Inc.","isPivotal":false,"enrollment":396,"indication":"Covid19","completionDate":"2021-10-07"},{"nctId":"NCT03058094","phase":"Phase 3","title":"A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI","status":"WITHDRAWN","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":true,"enrollment":0,"indication":"NSCLC","completionDate":"2020-01"},{"nctId":"NCT03856697","phase":"Phase 3","title":"A Randomized Controlled, Double-blind, Multicenter, Phase III Clinical Study to Compare Efficacy and Safety of Abivertinib Maleate Versus First-line Standard Therapy EGFR-TKI in Patients With Advanced","status":"UNKNOWN","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":true,"enrollment":406,"indication":"Advanced Non-small Cell Lung Cancer","completionDate":"2024-03"},{"nctId":"NCT03300115","phase":"Phase 2","title":"Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC","status":"UNKNOWN","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":false,"enrollment":222,"indication":"Metastatic Non-small Cell Lung Cancer","completionDate":"2020-12-17"},{"nctId":"NCT05361915","phase":"Phase 2","title":"A Phase 2 Study of AbiVERtinib in Combination With Abiraterone in Patients With Metastatic Castration Resistant Prostate Cancer (Maverick Trial)","status":"SUSPENDED","sponsor":"Sorrento Therapeutics, Inc.","isPivotal":false,"enrollment":100,"indication":"Prostate Cancer, Prostate Cancer Metastatic","completionDate":"2028-01"},{"nctId":"NCT04440007","phase":"Phase 2","title":"A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19","status":"COMPLETED","sponsor":"Sorrento Therapeutics, Inc.","isPivotal":false,"enrollment":96,"indication":"Covid-19","completionDate":"2021-08-23"},{"nctId":"NCT02274337","phase":"Phase 1","title":"Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor ","status":"UNKNOWN","sponsor":"Sun Yat-sen University","isPivotal":false,"enrollment":100,"indication":"Non-Small Cell Lung Cancer","completionDate":"2017-12"},{"nctId":"NCT03060850","phase":"Phase 1","title":"A Phase I Study of AC0010 in Patients With Relapsed or Refractory CLL/SLL, MCL, DLBCL and Other Non-Hodgkin B-Cell Lymphoma","status":"UNKNOWN","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":false,"enrollment":184,"indication":"B-cell Lymphoma","completionDate":"2020-12-14"},{"nctId":"NCT02330367","phase":"Phase 1","title":"Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Patients With EGFR T790M Positive Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With EGFR TKIs","status":"UNKNOWN","sponsor":"Hangzhou ACEA Pharmaceutical Research Co., Ltd.","isPivotal":false,"enrollment":368,"indication":"Metastatic Non-small Cell Lung Cancer","completionDate":"2023-03"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}