Phase III Study Comparing BL-M07D1 Injection to Chemotherapy for HER2-positive Advanced or Metastatic Gastric and Gastroesophageal Junction Cancer After First-line Treatment Failure

What this Trial Is About

Researchers are evaluating the efficacy and safety of BL-M07D1 in adults aged 18 to 75 with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma. This phase III, randomized, controlled, open-label, multicenter trial focuses on patients who have not responded to first-line anti-HER2 therapy and standard chemotherapy. The study aims to compare BL-M07D1 to investigators choice of chemotherapy after treatment failure. Participants are randomly assigned to receive either BL-M07D1 administered by intravenous infusion in 3-week cycles or chemotherapy chosen by the investigator, given by intravenous infusion in 2 to 4-week cycles. Treatment continues for additional cycles if clinical benefit is observed, but administration will stop if the disease progresses, intolerable side effects occur, or for other reasons. The study evaluates both treatment options over a period of up to 24 months. During the trial, participants undergo assessments to monitor overall survival and progression-free survival as primary outcomes, along with secondary measures such as response rates, disease control, treatment side effects, and immune responses. Safety monitoring includes tracking adverse events and antibody formation against the drug. Participants are followed closely throughout the treatment period with evaluations conducted regularly to assess treatment impact and tolerability.

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