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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07152405
Phase
PHASE3
Status
Recruiting
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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Interventions

  • BL-M07D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.
  • Investigator's choice of chemotherapy — DRUG
    Administration by intravenous infusion for a cycle of 2 or 3 or 4 weeks.

Study Details

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.

Key Dates

First listed
Sep 3, 2025
Start date
Sep 24, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: BL-M07D1
    Participants receive BL-M07D1 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: Investigator's choice of chemotherapy
    Participants receive investigator's choice of chemotherapy 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.

Primary Outcome Measure

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

Central Contacts

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