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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07518147
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M05D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Paclitaxel — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.
  • Docetaxel — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Irinotecan hydrochloride — DRUG
    Administration by intravenous infusion for a cycle of 2 weeks.

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
438 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M05D1
    Participants receive BL-M05D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
  • Active Comparator: Paclitaxel or Docetaxel or Irinotecan hydrochloride
    Participants receive Paclitaxel or Docetaxel or Irinotecan hydrochloride in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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