Cadonilimab (Not yet branded)

Immunotherapy

US Experimental EU Experimental ES Not available IV 19 Clinical Trials
PD-1 CTLA-4

Description

Cadonilimab (AK104) is a bispecific antibody immunotherapy agent that simultaneously targets both PD-1 and CTLA-4 immune checkpoint pathways in a single molecule. In colorectal cancer treatment, it is being used in combination with chemotherapy regimens like mFOLFOXIRI and bevacizumab for both locally advanced and metastatic disease. The drug shows activity across different molecular subtypes including microsatellite stable (MSS), microsatellite instability-high (MSI-H), and BRAF-mutated colorectal cancers.

Mechanism of Action

Cadonilimab functions as a bispecific immune checkpoint inhibitor that blocks both PD-1 and CTLA-4 receptors on T cells, effectively removing dual brakes on the immune system. By simultaneously inhibiting these two key checkpoint pathways, it aims to enhance T cell activation and tumor immune response more effectively than single-agent checkpoint inhibitors.

Molecular Targets

Side Effects

Fatigue Skin rash Diarrhea Decreased appetite Nausea Elevated liver enzymes Hypothyroidism Immune-mediated colitis

Not all side effects are listed. Side effects vary by individual. Always consult your oncologist.

Clinical Trials

NCT07412613 Phase 3
Recruiting
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
China
NCT07544784 Phase 2
Recruiting
AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
China
NCT06551207 Not Applicable
Recruiting
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC
China
NCT07253896 Phase 2
Recruiting
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
China
NCT06218810 Phase 2
Recruiting
Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS-Type, RAS-Mutated Metastatic Colorectal Cancer
China
NCT05985109 Phase 2
Recruiting
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
China
View all 19 clinical trials →