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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

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

438 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator