{"id":"hrs-8080","safety":{"commonSideEffects":[]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Limited public information is available on the specific molecular mechanism of HRS-8080. As a phase 3 oncology candidate from a Chinese cancer center, it is likely a targeted therapy or immunotherapy, but the exact target and mechanism require access to clinical trial registries or company disclosures for confirmation.","oneSentence":"HRS-8080 is an investigational anti-cancer agent being developed by Henan Cancer Hospital, currently in phase 3 clinical trials.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:45:48.995Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cancer (specific indication unknown)"}]},"trialDetails":[{"nctId":"NCT07354022","phase":"PHASE3","title":"A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-03-04","conditions":"Locally Advanced or Metastatic Breast Cancer","enrollment":912},{"nctId":"NCT07349069","phase":"PHASE3","title":"A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-03-04","conditions":"Breast Cancer","enrollment":4800},{"nctId":"NCT07389733","phase":"PHASE1, PHASE2","title":"A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-02","conditions":"Advanced Unresectable or Metastatic Breast Cancer of Adults","enrollment":180},{"nctId":"NCT06679036","phase":"PHASE1, PHASE2","title":"A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2025-01-21","conditions":"Advanced Unresectable or Metastatic Breast Cancer","enrollment":300},{"nctId":"NCT07024173","phase":"PHASE3","title":"A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2025-07-23","conditions":"Locally Advanced Breast Cancer, Metastatic Breast Cancer","enrollment":240},{"nctId":"NCT07229560","phase":"PHASE1","title":"A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants","status":"COMPLETED","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2025-11-26","conditions":"Breast Cancer","enrollment":16},{"nctId":"NCT06167694","phase":"PHASE1, PHASE2","title":"Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2023-12-20","conditions":"Unresectable or Metastatic Breast Cancer","enrollment":146},{"nctId":"NCT07320521","phase":"PHASE1","title":"A Study to Assess the Mass Balance of [14C]HRS-8080 in Healthy Chinese Postmenopausal Female Subjects.","status":"NOT_YET_RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2026-01","conditions":"Breast Cancer","enrollment":6},{"nctId":"NCT07125950","phase":"PHASE2","title":"SHR2554 Combined With Endocrine Therapy in Advanced Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Henan Cancer Hospital","startDate":"2025-09-30","conditions":"Advanced Breast Cancer","enrollment":60},{"nctId":"NCT06555068","phase":"PHASE1, PHASE2","title":"A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients","status":"RECRUITING","sponsor":"Jiangsu HengRui Medicine Co., Ltd.","startDate":"2024-08-12","conditions":"Advanced Unresectable or Metastatic Breast Cancer","enrollment":528},{"nctId":"NCT06222879","phase":"PHASE1, PHASE2","title":"Study of HRS-8080 or SHR-A2009 Combined With Anti-tumor Therapy in Patients With Unresectable or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2024-02-20","conditions":"Breast Cancer","enrollment":350},{"nctId":"NCT06619873","phase":"PHASE1","title":"A Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects","status":"NOT_YET_RECRUITING","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2024-10-10","conditions":"Breast Cancer","enrollment":24},{"nctId":"NCT05189717","phase":"PHASE1","title":"A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults","status":"UNKNOWN","sponsor":"Shandong Suncadia Medicine Co., Ltd.","startDate":"2022-02-17","conditions":"Metastatic or Local Advanced Breast Cancer of Patients","enrollment":156}],"_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":[],"phase":"phase_3","status":"active","brandName":"HRS-8080","genericName":"HRS-8080","companyName":"Henan Cancer Hospital","companyId":"henan-cancer-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"HRS-8080 is an investigational anti-cancer agent being developed by Henan Cancer Hospital, currently in phase 3 clinical trials. Used for Cancer (specific indication unknown).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}