{"id":"tqb3616-capsules","safety":{"commonSideEffects":[{"rate":null,"effect":"Hyperphosphatemia"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Stomatitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"TQB3616 selectively inhibits FGFR tyrosine kinases, which are frequently dysregulated in various cancers through gene amplification, mutation, or translocation. By blocking FGFR-mediated signaling, the drug suppresses tumor cell proliferation and survival in FGFR-dependent malignancies. This mechanism is particularly relevant in cancers with FGFR alterations, including certain lung, gastric, and other solid tumors.","oneSentence":"TQB3616 is a small-molecule inhibitor that targets fibroblast growth factor receptor (FGFR) signaling pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:39:38.422Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors with FGFR alterations (in development)"}]},"trialDetails":[{"nctId":"NCT05365178","phase":"PHASE3","title":"To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2022-07-01","conditions":"HR-positive, HER2-negative Breast Neoplasms","enrollment":432},{"nctId":"NCT06851442","phase":"PHASE1, PHASE2","title":"Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer","status":"TERMINATED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2025-05-16","conditions":"Breast Cancer","enrollment":8},{"nctId":"NCT05496569","phase":"PHASE2","title":"TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma","status":"TERMINATED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2022-08-08","conditions":"Dedifferentiated Liposarcoma","enrollment":26},{"nctId":"NCT06702618","phase":"PHASE2","title":"Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2025-01","conditions":"Breast Cancer","enrollment":33},{"nctId":"NCT06662773","phase":"PHASE1","title":"Drug-Drug Interaction (DDI) Study for TQB3616","status":"NOT_YET_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2024-11","conditions":"Healthy","enrollment":40},{"nctId":"NCT05375461","phase":"PHASE3","title":"TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2022-03-18","conditions":"HR-positive,HER2-negative in Advanced Breast Cancer","enrollment":287},{"nctId":"NCT06202261","phase":"PHASE1, PHASE2","title":"A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer","status":"RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2023-04-13","conditions":"Metastatic Breast Cancer, Recurrent Breast Cancer, Advanced Malignancies","enrollment":154},{"nctId":"NCT05780567","phase":"PHASE3","title":"Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer","status":"RECRUITING","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2023-03-30","conditions":"Breast Cancer","enrollment":1946},{"nctId":"NCT05344729","phase":"PHASE1","title":"Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2021-07-06","conditions":"Recurrent/Metastatic Breast Cancer","enrollment":16},{"nctId":"NCT05156450","phase":"PHASE2","title":"TQB3616 Capsules Combined With Abiraterone Acetate Plus Prednisone in Metastatic Castration-Resistant Prostate Cancer","status":"UNKNOWN","sponsor":"West China Hospital","startDate":"2022-01-01","conditions":"Prostatic Neoplasms, Castration-Resistant, Drug Therapy, Combination","enrollment":30},{"nctId":"NCT05139082","phase":"PHASE1, PHASE2","title":"Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors","status":"UNKNOWN","sponsor":"Peking University","startDate":"2021-11-24","conditions":"Digestive System Tumors","enrollment":60},{"nctId":"NCT04924192","phase":"PHASE2","title":"A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2021-08-18","conditions":"Advanced Lung Carcinoma","enrollment":126},{"nctId":"NCT04796623","phase":"PHASE2","title":"A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2021-02-04","conditions":"HR-positive, HER2-negative Advanced Breast Cancer","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"TQB3616 capsules","genericName":"TQB3616 capsules","companyName":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","companyId":"chia-tai-tianqing-pharmaceutical-group-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"TQB3616 capsules are a small molecule intervention being studied in clinical trials for various conditions, including breast cancer, advanced lung carcinoma, and digestive system tumors. The exact mechanism of TQB3616 capsules is not specified in the provided information, but they are being investigated in combination with other treatments such as fulvestrant injection and hormone receptor-positive therapies.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}