About this trial
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M05D1 in patients with Claudin (CLDN) 18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC) who have received prior first-line treatment.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Prior anti-tumor treatment;
Positive HER2 expression in tumor tissue;
History of severe cardiovascular or cerebrovascular disease;
Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias;
Trial design
Treatments tested in this trial
- BL-M05D1
- Paclitaxel
- Docetaxel
- Irinotecan hydrochloride
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator