About this trial
This trial is a multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age at the time of signing the informed consent form ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Underwent surgical treatment, radical radiotherapy, immunotherapy, etc., within 4 weeks before the first dose or within 5 half-lives;
Pathology indicates non-small cell carcinoma containing small cell carcinoma components and sarcomatoid carcinoma;
Previously received HER2-targeted therapy or ADC drug treatment with camptothecin derivatives as toxins;
History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
Trial design
Treatments tested in this trial
- BL-M07D1
- Pembrolizumab
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator