# Cadonilimab

Source: https://onco.cc/drugs/cadonilimab/  
OnCo record `cadonilimab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Chinese two-armed antibody that blocks PD-1 and CTLA-4 together, approved in China for cervical cancer and extending survival even in PD-L1-negative tumours.

## Summary

Cadonilimab is Akeso's tetravalent PD-1/CTLA-4 bispecific. NMPA approval June 2022 (second-line cervical cancer, ORR ~33%) and 2024 for first-line combination with chemotherapy ± bevacizumab (COMPASSION-16, OS HR 0.64). Also approved in China for first-line gastric cancer (COMPASSION-15, 2024). Designed for tumour-enriched dual blockade with lower immune toxicity than ipilimumab + nivolumab. It had not been approved in the US or EU by 2026.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Kaitanni
- Code: AK104
- Modality: Bispecific antibody (PD-1×CTLA-4)
- Mechanism: Binds PD-1 and CTLA-4 simultaneously; higher avidity for cells co-expressing both (tumour-infiltrating T cells) concentrates activity in the tumour.
- Approvals: China 2022: Recurrent/metastatic cervical cancer after platinum; China 2024: First-line persistent/recurrent/metastatic cervical cancer with chemotherapy ± bevacizumab; first-line gastric cancer with chemotherapy
- Dosing: Intravenous; 10 mg/kg every 3 weeks with platinum-paclitaxel ± bevacizumab
- Toxicity (grade 3+): Grade ≥3 treatment-related adverse events 82%

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Cadonilimab

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/), [PD-1](https://onco.cc/targets/pd1/)
- companies: [Akeso](https://onco.cc/companies/akeso/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- trials: [A Phase II Clinical Study of AK104/AK112 in Combination With TT-00420 Tablet for Advanced HCC.](https://onco.cc/trials/nct07052253/), [A Phase III Clinical Study of Cadonilimab Plus SOX as Perioperative Treatment for Patients With Resectable G/GEJ Adenocarcinoma](https://onco.cc/trials/nct07023315/), [A Phase III Study of AK104 as Adjuvant Therapy in HCC With High Risk of Recurrence After Curative Resection](https://onco.cc/trials/nct05489289/), [A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC](https://onco.cc/trials/nct06617416/), [A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer](https://onco.cc/trials/nct05859750/), [A Study of AK104/Placebo Combined With Chemoradiotherapy For The Treatment of Locally Advanced Cervical Cancer](https://onco.cc/trials/nct05235516/), [A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer](https://onco.cc/trials/nct05990127/), [A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepat](https://onco.cc/trials/nct06371157/), [A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)](https://onco.cc/trials/nct06530251/), [A Study of Ivonescimab in First-Line ES-SCLC](https://onco.cc/trials/nct07245446/), [A Study to Efficacy and Safety of SPH4336 Monotherapy or in Combination With Cadonilimab in Patients With Advanced Solid Tumors.](https://onco.cc/trials/nct05944224/), [AK104 for Recurrent or Metastatic Vulvar Cancer](https://onco.cc/trials/nct05932212/), [AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)](https://onco.cc/trials/nct07544784/), [AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer](https://onco.cc/trials/nct05904379/), [AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer](https://onco.cc/trials/nct06646055/), [An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer](https://onco.cc/trials/nct06560112/), [Anlotinib+Cadonilimab+PULSAR in Advanced Biliary Tract Cancer](https://onco.cc/trials/nct07635290/), [Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer](https://onco.cc/trials/nct06566755/), [Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct06367088/), [Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC](https://onco.cc/trials/nct06168786/), [Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma](https://onco.cc/trials/nct06438822/), [Cadonilimab Combined With S-1 or Capecitabine as Second-line Treatment for Advanced Pancreatic Cancer](https://onco.cc/trials/nct06532617/), [COMPASSION-16 / AK104-303](https://onco.cc/trials/compassion-16/), [DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy](https://onco.cc/trials/nct06221748/), [FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)](https://onco.cc/trials/nct07815834/), [Ligufalimab and Cadonilimab in Advanced Liver Cancers](https://onco.cc/trials/nct06789848/), [NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC](https://onco.cc/trials/nct06405490/), [Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer](https://onco.cc/trials/nct07412613/), [Phase II Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC](https://onco.cc/trials/nct07003022/), [SBRT, Chemotherapy, and AK104 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC)](https://onco.cc/trials/nct06401005/), [Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer](https://onco.cc/trials/nct06202313/)
- people: [Michelle Xia (Xia Yu)](https://onco.cc/people/xia-michelle/)

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