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AK104(IV)
AK104 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses.
AK104 is a bispecific antibody that simultaneously engages PD-1 on immune cells and TIM-3 on T cells to enhance anti-tumor immune responses. Used for Advanced or metastatic non-small cell lung cancer, Advanced hepatocellular carcinoma, Other advanced solid tumors (in development).
At a glance
| Generic name | AK104(IV) |
|---|---|
| Sponsor | Akeso |
| Drug class | Bispecific checkpoint inhibitor |
| Target | PD-1 and TIM-3 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AK104 functions as a PD-1/TIM-3 bispecific antibody that blocks two inhibitory checkpoints on T cells, thereby relieving immune suppression in the tumor microenvironment. By targeting both PD-1 and TIM-3, the drug aims to overcome resistance to single-checkpoint inhibition and restore robust anti-tumor immunity. This dual-checkpoint approach is designed to improve efficacy in patients with advanced solid tumors.
Approved indications
- Advanced or metastatic non-small cell lung cancer
- Advanced hepatocellular carcinoma
- Other advanced solid tumors (in development)
Common side effects
- Fatigue
- Nausea
- Decreased appetite
- Immune-related adverse events (pneumonitis, hepatitis, colitis)
Key clinical trials
- A Study of AK104 (SC) in Combination With Oxaliplatin and Capecitabine (XELOX) Versus AK104 (IV) in Combination With XELOX in Participants With Unresectable Locally Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (PHASE3)
- THIO and Cadonilimab in Resectable Hepatocellular Carcinoma (EARLY_PHASE1)
- Phase II Study of AK104 (Cadonilimab) for Recurrent Small Cell Neuroendocrine Carcinomas of the Cervix (PHASE2)
- Ligufalimab and Cadonilimab in Advanced Liver Cancers (PHASE2)
- IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial (PHASE2)
- Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) (PHASE2)
- A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (PHASE1, PHASE2)
- A Study of AK104 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |