Phase 1 Study of Bulumtatug Fuvedotin to Treat Recurrent or Metastatic Triple-Negative Breast Cancer in Patients Previously Treated with Antibody-Drug Conjugates

What this Trial Is About

Researchers are studying bulumtatug fuvedotin to evaluate its potential effectiveness in patients with triple-negative breast cancer who have previously been treated with antibody-drug conjugates. This phase Ib, open-label trial focuses on patients with recurrent or metastatic disease to better understand the drugs impact in this specific group. The study is sponsored by Mabwell Shanghai Bioscience Co., Ltd. and aims to assess important outcomes related to tumor response and safety. Participants will receive bulumtatug fuvedotin through intravenous infusions on day 1 and day 8 of each 21-day cycle. Two different dose levels are being tested to compare their effects. The study employs a randomized design without masking, meaning both patients and researchers know the treatment being administered. The trial period for assessing outcomes is planned for up to approximately two years. During the study, participants will undergo regular evaluations including tumor measurements to assess response, blood tests to monitor drug levels and immune reactions, and safety checks for side effects. Researchers will monitor outcomes such as objective tumor response, disease control, survival, and drug pharmacokinetics. Participants must meet specific health criteria and will be followed closely throughout the study duration to gather comprehensive data on treatment effects and safety.

A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs