A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive L… (NCT07152405) | Clinical Trial Compass
RecruitingPhase 3
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma
China490 participantsStarted 2025-09-24
Plain-language summary
This trial is a registrational Phase III, randomized, controlled, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction (G/GEJ) adenocarcinoma after failure of first-line anti-HER2 therapy and first-line standard chemotherapy.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 is ≥18 years and ≤75 years;
✓. Expected survival time ≥3 months;
✓. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma;
✓. Must have at least one measurable target lesion as defined by RECIST v1.1;
✓. ECOG performance status score of 0 or 1;
✓. Toxicity from previous antitumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
Exclusion criteria
✕. Received chemotherapy with mitomycin C and nitrosoureas within 6 weeks prior to the first dose, or underwent major surgery, radical radiotherapy, immunotherapy, etc., within 4 weeks prior to the first dose;
✕. Previous treatment with HER2-ADC drugs, or ADC drugs with topoisomerase 1 inhibitors as the payload, or prior irinotecan therapy;
✕. History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
✕. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrollable arrhythmias;