Last reviewed · How we verify
AK111
AK111 is a bispecific antibody that simultaneously engages CD3 on T cells and EGFR on tumor cells to redirect immune attack against EGFR-expressing cancers.
AK111 is a bispecific antibody that simultaneously engages CD3 on T cells and EGFR on tumor cells to redirect immune attack against EGFR-expressing cancers. Used for EGFR-expressing solid tumors (in clinical development).
At a glance
| Generic name | AK111 |
|---|---|
| Sponsor | Akeso |
| Drug class | Bispecific T-cell engager (BiTE) |
| Target | CD3 and EGFR |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AK111 functions as a T-cell engager by binding CD3 on cytotoxic T lymphocytes while also binding EGFR on cancer cells, bringing these cells into close proximity and activating T-cell killing of EGFR+ tumor cells. This bispecific approach leverages the patient's own immune system to target malignant cells expressing elevated EGFR levels, a common feature in many solid tumors.
Approved indications
- EGFR-expressing solid tumors (in clinical development)
Common side effects
- Cytokine release syndrome
- Infusion-related reactions
- T-cell activation-related toxicity
Key clinical trials
- A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis (PHASE3)
- A Clinical Study of AK139 in Healthy Subjects (PHASE1)
- A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis (PHASE1)
- A Phase 2 Study of Efficacy and Safety of AK111 in Subjects With Moderate-to-Severe Psoriasis (PHASE2)
- A Study of AK111 in Healthy Subjects (PHASE1)
- A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Moderate to Severe Plaque Psoriasis (PHASE3)
- To Evaluate the Efficacy and Safety of AK111 Injection in the Treatment of Moderate to Severe Plaque Psoriasis (PHASE2)
- A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AK111 CI brief — competitive landscape report
- AK111 updates RSS · CI watch RSS
- Akeso portfolio CI