Trials 207 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07446257 | Jun 2026 → Sep 2029 expected | hepatocellular carcinoma | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07586904 | May 2025 → Dec 2026 expected | cutaneous melanoma | Xijing Hospital | Recruiting | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT07619001 | Jun → Sep 2026 expected | — | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06913218 | Jul 2025 → Feb 2028 expected | pancreatic ductal adenocarcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07359235 | Nov 2024 → Dec 2028 expected | urinary bladder cancer | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT05856864 | Jun → Jul 2024 | hepatocellular carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT06424626 | May 2024 → Dec 2027 expected | metastatic melanoma, mucosal melanoma | Peking University Cancer Hospital & Institute | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT05868876 | Jun 2023 → Nov 2025 overdue | cancer | Akeso | Recruiting | No outcome recorded |
| Phase 1 | NCT05737368 | Feb 2023 → Feb 2024 | glioblastoma | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 1 | NCT05644392 | Nov 2022 → Nov 2025 | — | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05644379 | Nov 2022 → Nov 2025 overdue | — | Tianjin Medical University Cancer Institute and Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04572152 | Dec 2020 → May 2023 | — | Akeso | Completed | No outcome recorded |
| Phase 1 | NCT04349969 | Apr 2020 → Nov 2022 | cancer | Akeso Biopharma, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03261011 | Oct 2017 → Aug 2021 | cancer of unknown primary site | Akeso Biopharma, Inc. | Completed | No outcome recorded |
| Phase 1/228 trials | ||||||
| Phase 1/2 | NCT06940921 | Mar 2025 → Nov 2027 expected | colorectal cancer, gastric cancer, ovarian cancer, peritoneal carcinomatosis | Zhang Tao | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06762080 | Mar 2025 → Jan 2026 overdue | malignant leptomeningeal tumor | Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06646055 | Jan 2025 → Dec 2026 expected | pancreatic ductal adenocarcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06530251 | Sep 2024 → Jun 2026 overdue | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06586294 | Sep 2024 → Jul 2026 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06577961 | Aug 2024 → Aug 2027 expected | renal cell carcinoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06650332 | Jul 2024 → Aug 2026 overdue | gastroesophageal cancer | Zhejiang Cancer Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06477523 | May 2024 → Dec 2026 expected | small cell lung carcinoma | Sichuan University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05808608 | Nov 2023 → Apr 2026 overdue | sarcomatoid renal cell carcinoma | Hao Zeng | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05944224 | Oct 2023 → May 2026 overdue | cancer | Shanghai Pharmaceuticals Holding Co., Ltd | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05773105 | Sep 2023 → Mar 2026 | hepatocellular carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 1/2 | NCT05898256 | Aug 2023 → Jul 2024 overdue | nasopharyngeal carcinoma | Guangxi Medical University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05904379 | Jul 2023 → Jun 2026 overdue | non-small cell lung carcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05915481 | Jun 2023 → Jun 2024 | neoplasm | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05816499 | Feb 2023 → Dec 2024 | non-small cell lung carcinoma | Shanghai Chest Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05426005 | Feb 2023 → Sep 2026 expected | colorectal cancer | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06040177 | Feb 2023 | hepatocellular carcinoma, portal vein thrombosis | First Affiliated Hospital of Guangxi Medical University | Unknown | No outcome recorded |
| Phase 1/2 | NCT05559541 | Dec 2022 → May 2024 | cancer | Akeso | Terminated | No outcome recorded |
| Phase 1/2 | NCT05505825 | Aug 2022 → Jul 2024 | small cell lung carcinoma | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT05235542 | Mar 2022 → May 2026 | cancer | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT05142423 | Nov 2021 → Apr 2027 expected | — | Akeso | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04982276 | Aug 2021 → Dec 2025 overdue | gastroesophageal adenocarcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04647344 | Nov 2020 → Dec 2023 | non-small cell lung carcinoma | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT04646330 | Nov 2020 → Oct 2023 | non-small cell lung carcinoma | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT04444167 | Jul 2020 → Nov 2023 | hepatocellular carcinoma | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT04444141 | May 2020 → Sep 2022 | peripheral T-cell lymphoma, not otherwise specified | Akeso | Terminated | No outcome recorded |
| Phase 1/2 | NCT04172454 | Dec 2019 → Jun 2021 | cancer, melanoma | Akeso | Completed | No outcome recorded |
| Phase 1/2 | NCT03852251 | Jan 2019 → Mar 2024 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Akeso | Completed | No outcome recorded |
| Phase 2138 trials | ||||||
| Phase 2 | NCT07635290 | Jun 2026 → Jun 2027 expected | biliary tract cancer | West China Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07631000 | May 2026 → May 2029 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06889610 | Mar 2026 → Dec 2027 expected | colorectal cancer, melanoma, triple-negative breast carcinoma | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07450963 | Mar 2026 → Feb 2029 expected | cervical cancer | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07263919 | Dec 2025 → Mar 2030 expected | esophageal squamous cell carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT07243951 | Nov 2025 → Dec 2026 expected | combined hepatocellular carcinoma and cholangiocarcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07544784 | Nov 2025 → Dec 2027 expected | metastasis from malignant tumor of colon | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07245446 | Oct 2025 → Dec 2027 expected | small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT07052253 | Jul 2025 → May 2027 expected | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 2 | NCT06984718 | Jun 2025 → Nov 2026 expected | hepatocellular carcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Show all 138 trials opens the full record — a long page | ||||||
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT06221748 | Feb 2024 → Dec 2026 expected | gastric cancer, gastroesophageal junction adenocarcinoma | RemeGen Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06241599 | Feb 2024 → Feb 2026 overdue | nasopharyngeal carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT07700979 | Aug 2026 → Aug 2029 expected | gastroesophageal adenocarcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07400536 | Apr 2026 → Jul 2028 expected | cervical carcinoma | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | No outcome recorded |
| Phase 3 | NCT07412613 | Apr 2026 → Jun 2030 expected | colorectal cancer | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT07449780 | Mar 2026 → Nov 2027 expected | gastroesophageal adenocarcinoma | Akeso | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07023315 | Aug 2025 → Jul 2029 expected | gastroesophageal adenocarcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06949033 | May 2025 → Dec 2028 expected | gastroesophageal cancer | Zuoyi Jiao | Recruiting | No outcome recorded |
| Phase 3 | NCT06617416 | Nov 2024 → Oct 2026 expected | non-small cell lung carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06664983 | Oct 2024 → Oct 2025 overdue | nasopharyngeal carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06542549 | Oct 2024 → Oct 2027 expected | ovarian carcinoma | Anhui Provincial Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06371157 | Aug 2024 → Oct 2025 overdue | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06341335 | Jun 2024 → Nov 2026 expected | adenocarcinoma | Akeso | Recruiting | No outcome recorded |
| Phase 3 | NCT06566755 | Feb 2024 → Feb 2026 overdue | colorectal cancer | Caigang Liu | Recruiting | No outcome recorded |
| Phase 3 | NCT05941741 | Jan 2024 → Dec 2027 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 3 | NCT05990127 | Nov 2023 → Aug 2025 overdue | — | Akeso | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05587374 | Aug 2023 → Aug 2027 expected | nasopharyngeal carcinoma | Sun Yat-sen University | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05235516 | Jun 2022 → May 2026 overdue | cervical carcinoma | Akeso | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05008783 | Sep 2021 → Dec 2024 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Akeso | Completed | No outcome recorded |
| Phase 3 | NCT04982237 | Aug 2021 → Dec 2025 overdue | cervical cancer | Akeso | Active not recruiting | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06878196 | Mar 2025 → Dec 2028 expected | cervical cancer | Obstetrics & Gynecology Hospital of Fudan University | Not yet recruiting | No outcome recorded |
| — | NCT06715501 | Dec 2024 → Sep 2025 overdue | esophageal squamous cell carcinoma | First Affiliated Hospital of Ningbo University | Enrolling by invitation | No outcome recorded |
| — | NCT06714084 | Oct 2024 → Dec 2025 overdue | cervical cancer | Hubei Cancer Hospital | Enrolling by invitation | No outcome recorded |
| — | NCT06553781 | Sep 2024 → Sep 2025 overdue | melanoma | Fudan University | Not yet recruiting | No outcome recorded |
| — | NCT06551207 | Aug 2024 → Dec 2026 expected | colorectal cancer | Liu Huang | Recruiting | No outcome recorded |
| — | NCT06265350 | Feb 2024 → Jan 2026 overdue | hepatocellular carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| — | NCT05800080 | Apr 2023 → Feb 2024 | gastric cancer | Xijing Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05021120 Background | Oct 2021 → Oct 2024 | — | Akeso Biopharma, Inc. | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT06552598 Background | Apr 2024 → Apr 2028 expected | cervical cancer, endometrial cancer | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT05559554 Comparator | Oct 2022 → Mar 2023 | — | Akeso | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07556640 Comparator | Apr 2026 → Apr 2028 expected | gastric cancer, gastroesophageal adenocarcinoma, peritoneal carcinomatosis | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05489289 Comparator | Jan 2023 → Jan 2026 overdue | hepatocellular carcinoma | Akeso | Recruiting | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-21 | Akeso | 康方生物卡度尼利（PD-1/CTLA-4双抗，AK104）一线治疗晚期宫颈癌III期研究入组完成 akesobio.com ↗ |
| 2022-06-10 | Akeso | 康方生物卡度尼利（PD-1/CTLA-4双抗，AK104）获批开展针对HCC术后辅助治疗的Ⅲ期临床研究 akesobio.com ↗ |
| 2022-06-06 | Akeso | 康方生物在2022 ASCO年会中以口头报告形式发布PD-1/CTLA-4双抗（AK104）联合标准疗法一线治疗复发/转移性宫颈癌的II期研究数据 akesobio.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 216 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cadonilimab | “Efficacy of Cadonilimab (AK104) Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS Colorectal Cancer With Liver...” NCT07544784 ↗150“Cadonilimab (AK104) is a first-in-class tetravalent bispecific antibody that targets both PD-1 and CTLA-4, showing a manageable safety profile and favorable clinical benefits.” PMID 38280003 ↗ Jan 2024 “Cadonilimab (AK104) + Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma” NCT06371157 ↗ “Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks” NCT06789848 ↗ “Cadonilimab （Moderate dose）+ albumin paclitaxel 90mg/m2, qw×6+ cisplatin 25mg/m2, qw×6” NCT07400536 ↗ “standard chemotherapy with cadonilimab, 6 mg/kg, is administered every two weeks.” NCT07079462 ↗ “Cadonilimab (AK104) is administered intravenously at 10 mg/kg every 3 weeks.” NCT06035224 ↗ “Cadonilimab is a humanized, bispecific antibody targeting PD-1 and CTLA-4.” NCT06714084 ↗ “Multimodal ablation combined with cadonilimab and fruquintinib” NCT06889610 ↗ “Anti-PD-1 and CTLA-4 Bispecific Antibody, Cadonilimab(AK104)” NCT05505825 ↗ “AK104/cadonilimab (PD-1/CTLA-4 bispecific): A case report.” PMID 36569905 ↗ Dec 2022 “Cadonilimab (a PD-1/CTLA-4 bispecific antibody) therapy” PMID 40600147 ↗ Jun 2025 “Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8” NCT06196775 ↗ “Cadonilimab (a PD-1/CTLA-4 bispecific antibody)” NCT05815303 ↗ “Ivonescimab combined with Cadonilimab plus EC” NCT06620796 ↗ “Cadonilimab 10mg/kg, D1 administration” NCT05926700 ↗ “Cadonilimab: 10mg/kg, Q3W, 3 cycles” NCT05941741 ↗ “RC48-ADC plus cadonilimab（AK104）” NCT06178601 ↗ “Drug: cadonilimab” NCT06650332 ↗ |
| Known as | AK104 | “The purpose of the trial is evaluated Disitamab Vedotin (RC48) plus Cadonilimab (AK104) as first-line therapy for HER2-overexpressing advanced stomach carcinoma, and also check...” NCT06492317 ↗88“Recently, cadonilimab (AK104), a bispecific antibody targeting PD-1 and CTLA-4, has demonstrated promising antitumor activity when combined with chemotherapy in advanced...” PMID 40070819 ↗ Feb 2025 “evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable...” NCT06406634 ↗ “AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint...” NCT07359235 ↗ “AK104 is a humanized bispecific antibody co-targeting PD-1 (Programmed Cell Death Protein 1) and CTLA-4 (Cytotoxic T-Lymphocyte-Associated Antigen 4)-two key immune checkpoint...” NCT06552598 ↗ “Cadonilimab (AK104) is a first-in-class tetravalent bispecific antibody that targets both PD-1 and CTLA-4, showing a manageable safety profile and favorable clinical benefits.” PMID 38280003 ↗ Jan 2024 “A Phase II Clinical Study of Cadonilimab (AK104) Combined With Chemotherapy in the Treatment of PD-1 Inhibitor Resistant Nasopharyngeal Carcinoma” NCT05790200 ↗ “Cadonilimab (AK104): 10 mg/kg administered via intravenous infusion over 60-120 minutes (minimum 60 minutes) on Day 1 of each 21-day cycle.” NCT07243951 ↗ “Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight \<60 kg) or 12mg (body weight ≥60 kg) orally QD.” NCT06361758 ↗ “A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors” NCT06427057 ↗ “Cadonilimab (AK104) 10 mg/kg IV over 60 minuets at least 30 minutes after Ligufalimab on Day 1 every 3 weeks” NCT06789848 ↗ “Cadonilimab（AK104）is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.” NCT05687851 ↗ “Cadonilimab (AK104) is humanized bispecific antibody that targets to PD-1 and CTLA-4 .” NCT06664983 ↗ “Cadonilimab (AK104) is administered intravenously at 10 mg/kg every 3 weeks.” NCT06035224 ↗ “AK104（6.0 mg/kg，intravenous (IV) infusion，Q2W）combined with RC48-ADC” NCT06178601 ↗ “Cadonilimab (AK104) combined with chemotherapy and bevacizumab” NCT06566755 ↗ “Cadonilimab (AK104) is an PD-1/CTLA-4 bispecific antibody.” NCT06401005 ↗ “Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8” NCT06196775 ↗ “Cadonilimab（AK104）:10mg/Kg,iv drip,d1,q3w” NCT05948449 ↗ “Drug: Cadonilimab (AK104)” NCT07263919 ↗ “Drug: Cadonilimab (AK104)” NCT06851104 ↗ “Cadonilimab (AK104)” NCT06448910 ↗ “Cadonilimab (AK104)” NCT06617416 ↗ “Cadonilimab (AK104)” NCT07412613 ↗ “Cadonilimab (AK104)” NCT06762080 ↗ “Cadonilimab (AK104)” NCT06467500 ↗ |
| Known as | Cadonilimab (AK104) | “Cadonilimab (AK104)” NCT05571644 ↗ |
| Known as | Candonilimab | “Surgical Conversion of Candonilimab (AK104) Plus Paclitaxel, S-1 and Apatinib for Unresectable Advanced G/GEJ Cancer” NCT05853172 ↗ |
| Known as | cardonilizumab | “Cadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on...” NCT05925413 ↗ |
| Known as | cardonirimab | “As a bispecific antibody against PD-1 and CTLA-4, cardonirimab can not only induce the production of a large number of T cells in the early stage of immune response by...” NCT05824494 ↗ |
| Action | Inhibit | “cadonilimab (anti PD-1 and CTLA-4 bispecific antibody)” PMID 37677918 ↗ Aug 2023 |
| Modality | Monoclonal antibody | “AK104, a PD-1/CTLA-4 Bispecific Antibody” NCT04547101 ↗ |
| Route | Intravenous | “Subjects will receive AK104 by intravenous administration.” NCT03261011 ↗ |
| Target | CTLA4 | “AK104 (anti-PD-1 and CTLA4)” NCT06540729 ↗ |