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Placebo+AK111
AK111 is a bispecific antibody that simultaneously engages CD3 on T cells and a tumor-associated antigen to redirect immune cells toward cancer cells.
AK111 is a bispecific antibody that simultaneously engages CD3 on T cells and a tumor-associated antigen to redirect immune cells toward cancer cells. Used for Solid tumors or hematologic malignancies (specific indication under Phase 3 evaluation not fully disclosed in public domain).
At a glance
| Generic name | Placebo+AK111 |
|---|---|
| Sponsor | Akeso |
| Drug class | Bispecific T-cell engager (BiTE) |
| Target | CD3 and tumor-associated antigen (specific target not publicly disclosed) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
AK111 functions as a T-cell engager by binding CD3 on cytotoxic T lymphocytes while simultaneously targeting a tumor antigen, thereby bridging immune effector cells to malignant cells and promoting T-cell activation and tumor cell killing. This bispecific approach leverages the patient's own immune system to recognize and eliminate cancer cells. The placebo control in this Phase 3 trial allows assessment of AK111's efficacy independent of natural disease progression or placebo effects.
Approved indications
- Solid tumors or hematologic malignancies (specific indication under Phase 3 evaluation not fully disclosed in public domain)
Common side effects
- Cytokine release syndrome
- Immune-related adverse events
- Infusion reactions
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)
- 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 |