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

NCT07152405 | Recruiting Phase 3 DMC

• 1 other identifier: BL-M07D1-305
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS)

  Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

  Up to approximately 24 months

• Progression-free survival (PFS)

  Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

  Up to approximately 24 months

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Anti-drug antibody (ADA)

  Up to approximately 24 months

Study Arms (2)

BL-M07D1

EXPERIMENTAL

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.

Drug: BL-M07D1

Investigator's choice of chemotherapy

ACTIVE COMPARATOR

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.

Drug: Investigator's choice of chemotherapy

Interventions

BL-M07D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M07D1

Investigator's choice of chemotherapy DRUG

Administration by intravenous infusion for a cycle of 2 or 3 or 4 weeks.

Investigator's choice of chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤2+ or \<1000mg/24h;
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must be negative. Patients must not be lactating. All enrolled patients (regardless of gender) should adopt adequate barrier contraception methods throughout the treatment cycle and for 7 months after the end of treatment.

You may not qualify if:

• 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;
• Concurrent pulmonary diseases resulting in severe impairment of lung function;
• History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment, or current ILD/interstitial pneumonia;
• Diagnosis of other primary malignancies within 3 years prior to the first dose;
• Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg);
• Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
• History of allergy to recombinant humanized antibodies or any excipient components of BL-M07D1;
• History of autologous or allogeneic stem cell transplantation;
• Unstable deep vein thrombosis requiring anticoagulant therapy during the screening period, or newly diagnosed deep vein thrombosis within 14 days;
• Positive human immunodeficiency virus (HIV) antibody, active hepatitis B virus infection, or hepatitis C virus infection;
• Occurrence of severe infections within 4 weeks prior to the first dose of the investigational drug; presence of infections requiring systemic treatment during the screening period;
• Patients with massive serous cavity effusion, symptomatic serous cavity effusion, or poorly controlled serous cavity effusion;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (2)