Trials / Recruiting
RecruitingNCT06115902
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) -Expressing Relapsed/Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQB2102 for injection | TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC) |
Timeline
- Start date
- 2023-11-17
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2023-11-03
- Last updated
- 2023-11-29
Locations
20 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06115902. Inclusion in this directory is not an endorsement.