drugset / Trial / NCT06115902
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
Phase 1
Completed
153 enrolled
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment
Summary
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.
Timeline
- Start
- 2023-11-17
- Primary completion
- 2025-02-01
- Completion
- 2025-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TQB2102 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | TQB2102 | Monoclonal antibody | 7.5 mg/kg | Intravenous |