A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With C… (NCT07518147) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment
China438 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Pathologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;
✓. Patients who have failed prior first-line standard therapy must have evidence of radiographic clear progression;
✓. Ability to provide archived or fresh tumor tissue;
✓. Must have at least one measurable lesion as defined by RECIST v1.1;
Exclusion criteria
✕. 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;
✕. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to screening;