Phase IbII Study of BL-M07D1 Injection for Women With HER2-Positive Recurrent or Metastatic Gynecologic Cancers

What this Trial Is About

Researchers are evaluating the safety and effectiveness of BL-M07D1, an investigational drug given by intravenous infusion, in women with HER2-expressing recurrent or metastatic gynecologic cancers. This phase IbII trial focuses on patients who have not responded to standard treatments or have no available standard treatment options. The study is designed as a single-arm, open-label, multicenter trial to assess how well the drug works and its safety profile. Participants receive BL-M07D1 through an intravenous infusion during the first 3-week cycle. If the patient shows clinical benefit, they may continue to receive additional cycles of treatment. Treatment will stop if the disease progresses, if side effects become intolerable, or for other reasons determined by the study team. Throughout the study, researchers will monitor patients for up to approximately 24 months to evaluate outcomes such as the recommended dose for phase II, response rates, disease control, duration of response, and progression-free survival. Safety assessments include tracking adverse events and measuring drug levels and immune responses. Participants will provide tumor tissue samples and undergo regular evaluations to support these measurements and ensure ongoing monitoring of their health during the trial.

A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies