{"id":"tqb3616-capsule","safety":{"commonSideEffects":[{"rate":"20-30%","effect":"Fatigue"},{"rate":"10-20%","effect":"Diarrhea"},{"rate":"10-20%","effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"TQB3616 capsule works by inhibiting the PD-1/PD-L1 interaction, which is a key checkpoint in the immune system. This inhibition allows the immune system to recognize and attack cancer cells more effectively.","oneSentence":"TQB3616 capsule is a small molecule drug that targets the PD-1/PD-L1 pathway.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:39:37.248Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer, PD-L1 positive"},{"name":"Head and neck squamous cell carcinoma"}]},"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 capsule","genericName":"TQB3616 capsule","companyName":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","companyId":"chia-tai-tianqing-pharmaceutical-group-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"TQB3616 capsule is a small molecule drug that targets the PD-1/PD-L1 pathway. Used for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}