About this trial
This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.
Eligibility criteria
Qualifiers
Sign the informed consent form voluntarily and follow the protocol requirements;
Female;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
Disqualifiers
had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;
had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;
had a history of serious cardiovascular and cerebrovascular diseases;
active autoimmune or inflammatory diseases;
Trial design
Treatments tested in this trial
- BL-M07D1
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator