{"id":"ak-104","_chembl":{"chemblId":"CHEMBL3917749","moleculeType":"Small molecule","molecularWeight":"407.49"},"_dailymed":null,"_scrapedAt":"2026-03-28T04:33:25.196Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123488,"model":"claude-sonnet-4-5-20250929"},"description":"AK-104 is an investigational bispecific antibody being developed by Akesobio Australia Pty Ltd. The drug is currently in Phase 1 clinical trials. Limited public information is available regarding its molecular targets, mechanism of action, and specific therapeutic indications at this early stage of development.","indications":{"approved":[{"status":"investigational","condition":null,"patientPopulation":null}]},"trialDetails":[{"nctId":"NCT05941741","phase":"PHASE3","title":"IC Plus Low-dose Radiation Plus Cadonilimab in LANPC","status":"RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2024-01-10","conditions":"Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy","enrollment":380},{"nctId":"NCT07052253","phase":"PHASE2","title":"A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.","status":"RECRUITING","sponsor":"Akeso","startDate":"2025-07-18","conditions":"Hepatocellular Carcinoma (HCC)","enrollment":100},{"nctId":"NCT05824481","phase":"PHASE2","title":"Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial 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Cancer","status":"COMPLETED","sponsor":"Akeso","startDate":"2020-07-15","conditions":"Recurrent Cervical Cancer, Metastatic Cervical Cancer","enrollment":30},{"nctId":"NCT03261011","phase":"PHASE1","title":"Study of the Safety, Pharmacokinetics, and Antitumor Activity of AK104 in Subjects With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Akesobio Australia Pty Ltd","startDate":"2017-10-03","conditions":"Advanced Cancer","enrollment":119},{"nctId":"NCT04572152","phase":"PHASE1","title":"A Study of AK119 (Anti-CD73) in Combination With AK104 in Subjects With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Akeso","startDate":"2020-12-07","conditions":"Advanced or Metastatic Solid Tumors","enrollment":23},{"nctId":"NCT05559541","phase":"PHASE1, PHASE2","title":"Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors","status":"TERMINATED","sponsor":"Akeso","startDate":"2022-12-15","conditions":"Solid Tumor, Adult","enrollment":33},{"nctId":"NCT06511726","phase":"PHASE2","title":"Induction Chemotherapy Plus Cadonilimab for Locally Advanced Cervical Cancer","status":"RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2024-01-23","conditions":"Cervical Cancer","enrollment":29},{"nctId":"NCT06810895","phase":"","title":"Evaluation of AK104 (Cadonilimab) Combined with Chemotherapy for Recurrent or Metastatic Small Cell Neuroendocrine Carcinoma of the Cervix","status":"ENROLLING_BY_INVITATION","sponsor":"Ding Ma","startDate":"2025-02-01","conditions":"Cervix Cancer, Cadonilimab, Small Cell Neuroendocrine Carcinoma of the Cervix","enrollment":20},{"nctId":"NCT05792735","phase":"PHASE2","title":"Neoadjuvant Cadonilimab Plus Chemotherapy Following Short-Course Radiotherapy in Locally Advanced Rectal Cancer","status":"COMPLETED","sponsor":"Shenzhen People's Hospital","startDate":"2023-04-11","conditions":"Locally Advanced Rectal Carcinoma","enrollment":27},{"nctId":"NCT05808608","phase":"PHASE1, PHASE2","title":"A Study of AK104 Plus Axitinib in Advanced/Metastatic Special Pathological Subtypes of Renal Cell Carcinoma","status":"RECRUITING","sponsor":"Hao Zeng","startDate":"2023-11-17","conditions":"Renal Cell Carcinoma, First-line Treatment, Non Clear Cell Renal Cell Carcinoma","enrollment":33},{"nctId":"NCT06405490","phase":"PHASE2","title":"NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC","status":"RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2024-04-17","conditions":"Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin","enrollment":30},{"nctId":"NCT06035224","phase":"PHASE2","title":"A Study of Cadonilimab（AK104） Plus Lenvatinib in Previous Immunotherapy Treated Advanced/Metastatic Clear Cell Renal Cell Carcinoma","status":"RECRUITING","sponsor":"RenJi Hospital","startDate":"2023-08-23","conditions":"Clear Cell Renal Cell Carcinoma、Resistance to Immunotherapy","enrollment":28},{"nctId":"NCT05859750","phase":"PHASE2","title":"A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer","status":"RECRUITING","sponsor":"Akeso","startDate":"2023-05-25","conditions":"Pancreatic Cancer","enrollment":78},{"nctId":"NCT06472037","phase":"PHASE2","title":"AG Combined With Cadonilimab Sequential Short-course Radiotherapy in the Treatment of Locally aPDAC","status":"RECRUITING","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2024-07-01","conditions":"Locally Advanced Pancreatic Ductal Adenocarcinoma","enrollment":30},{"nctId":"NCT06401005","phase":"PHASE2","title":"SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)","status":"RECRUITING","sponsor":"Hubei Cancer Hospital","startDate":"2024-11-28","conditions":"Breast Cancer","enrollment":51},{"nctId":"NCT05227651","phase":"PHASE2","title":"AK104 in Neoadjuvant Treatment of Cervical Cancer","status":"COMPLETED","sponsor":"Akeso","startDate":"2023-02-10","conditions":"Cervical Cancer","enrollment":14},{"nctId":"NCT06650332","phase":"PHASE1, PHASE2","title":"Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients","status":"RECRUITING","sponsor":"Zhejiang Cancer Hospital","startDate":"2024-07-10","conditions":"Metastatic HER2 Positive Gastroesophageal Junction Cancer","enrollment":90},{"nctId":"NCT06620796","phase":"PHASE2","title":"A Phase II Study of Ivonescimab Combined with Cadonilimab and Chemotherapy in Extensive-stage Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","startDate":"2024-09-30","conditions":"SCLC, Extensive Stage","enrollment":70},{"nctId":"NCT05687851","phase":"PHASE2","title":"Study Of Cadonilimab Combined With Radiotherapy In The Treatment of Locally Advanced Cervical Cancer","status":"RECRUITING","sponsor":"Chongqing University Cancer Hospital","startDate":"2022-12-29","conditions":"Locally Advanced Cervical Cancer","enrollment":33},{"nctId":"NCT04220307","phase":"PHASE2","title":"A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma","status":"COMPLETED","sponsor":"Akeso","startDate":"2020-04-26","conditions":"Nasopharyngeal Carcinoma","enrollment":34},{"nctId":"NCT06587425","phase":"PHASE2","title":"The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced, Recurrent, or Metastatic CLDN18.2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma","status":"RECRUITING","sponsor":"Shanghai Zhongshan Hospital","startDate":"2024-07-31","conditions":"Gastric or Gastroesophageal Junction Adenocarcinoma","enrollment":50},{"nctId":"NCT06289751","phase":"PHASE2","title":"Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer","status":"RECRUITING","sponsor":"Tongji Hospital","startDate":"2024-09-03","conditions":"Cervical Cancer, Neoadjuvant Chemoimmunotherapy, Radical Hysterectomy","enrollment":50},{"nctId":"NCT06577961","phase":"PHASE1, PHASE2","title":"Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients","status":"NOT_YET_RECRUITING","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","startDate":"2024-08-31","conditions":"Kidney Cancer, RCC, Renal Cell Carcinoma","enrollment":37},{"nctId":"NCT06566755","phase":"PHASE3","title":"Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer","status":"RECRUITING","sponsor":"Caigang Liu","startDate":"2024-02-01","conditions":"Colorectal Cancer","enrollment":30},{"nctId":"NCT04349969","phase":"PHASE1","title":"A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104","status":"COMPLETED","sponsor":"Akesobio Australia Pty Ltd","startDate":"2020-04-23","conditions":"Neoplasms Malignant","enrollment":38},{"nctId":"NCT05235516","phase":"PHASE3","title":"A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Akeso","startDate":"2022-06-21","conditions":"Locally Advanced Cervical Carcinoma","enrollment":636},{"nctId":"NCT06542549","phase":"PHASE3","title":"Efficacy and Safety of AK104 (PD-1/CTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer","status":"NOT_YET_RECRUITING","sponsor":"Anhui Provincial Hospital","startDate":"2024-10-01","conditions":"Advanced Ovarian Cancer, AK104(PD-1/CTLA-4 Bispecial Antibody), Chemotherapy","enrollment":100},{"nctId":"NCT03852251","phase":"PHASE1, PHASE2","title":"A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ Adenocarcinoma","status":"COMPLETED","sponsor":"Akeso","startDate":"2019-01-18","conditions":"Gastric Adenocarcinoma, Advanced Solid Tumors, Gastroesophageal Junction Adenocarcinoma","enrollment":338},{"nctId":"NCT06532539","phase":"PHASE2","title":"Cadonilimab With Chemoradiation for Recurrent and Oligometastatic Endometrial Carcinoma","status":"RECRUITING","sponsor":"Shandong Cancer Hospital and Institute","startDate":"2024-06-13","conditions":"Endometrial Neoplasms, Neoplasm Recurrence, Local, Neoplasm Metastasis","enrollment":30},{"nctId":"NCT06455254","phase":"PHASE2","title":"Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM","status":"RECRUITING","sponsor":"Jin-hong Chen","startDate":"2024-07-11","conditions":"CRC","enrollment":44},{"nctId":"NCT06492317","phase":"PHASE2","title":"RC48 Plus AK104 as 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