{"id":"hbi-8000-in-combination-with-nivolumab","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Immune-related adverse events (from nivolumab component)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"HBI-8000 inhibits histone deacetylases, leading to increased acetylation of histones and non-histone proteins, which can promote anti-tumor immune responses and increase T-cell activation. When combined with nivolumab (a PD-1 inhibitor that blocks immune checkpoint signaling), the dual mechanism aims to overcome resistance to checkpoint inhibition and enhance anti-tumor immunity.","oneSentence":"HBI-8000 is a histone deacetylase (HDAC) inhibitor that enhances immune response when combined with nivolumab, a PD-1 checkpoint inhibitor.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:14:56.247Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors (Phase 3 development)"}]},"trialDetails":[{"nctId":"NCT04674683","phase":"PHASE3","title":"Study Comparing Investigational Drug HBI-8000 + Nivolumab vs. Placebo + Nivolumab in Patients With Advanced Melanoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"HUYABIO International, LLC.","startDate":"2021-08-12","conditions":"Unresectable or Metastatic Melanoma, Progressive Brain Metastasis","enrollment":450},{"nctId":"NCT02718066","phase":"PHASE1, PHASE2","title":"Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer","status":"COMPLETED","sponsor":"HUYABIO International, LLC.","startDate":"2016-08","conditions":"Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer","enrollment":96}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["For HBI-8000: Chidamide, CS055; for nivolumab: OPDIVO","For HBI-8000: tudicdinostat; For nivolumab: OPDIVO®"],"phase":"phase_3","status":"active","brandName":"HBI-8000 in combination with nivolumab","genericName":"HBI-8000 in combination with nivolumab","companyName":"HUYABIO International, LLC.","companyId":"huyabio-international-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HBI-8000 is a histone deacetylase (HDAC) inhibitor that enhances immune response when combined with nivolumab, a PD-1 checkpoint inhibitor. Used for Advanced or metastatic solid tumors (Phase 3 development).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}