An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates
Mabwell (Shanghai) Bioscience Co., Ltd.
Summary
The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Patient has measurable disease by RECIST v1.1 * Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines * Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload. * Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting. * Provision of archival tumor tissue or fresh tumor biopsy. * Capable of giving informed consent * Male or female subjects aged ≥ 18 years. * Subjects must be willing to receive blood transf…