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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Phase III Randomized Controlled Clinical Study of BL-M07D1 for Injection Versus Investigator's Choice of Chemotherapy 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

NCT07152405•Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily sign the informed consent form and comply with the protocol requirements;
•2. No gender restrictions;
•3. Age at the time of signing the informed consent form is ≥18 years and ≤75 years;
•4. Expected survival time ≥3 months;
•5. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma;
•6. Must have at least one measurable target lesion as defined by RECIST v1.1;
•7. ECOG performance status score of 0 or 1;
•8. Toxicity from previous antitumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
•9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
•10. Organ function levels must meet the requirements;
+3 more criteria

Exclusion Criteria

•1. 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;
•2. Previous treatment with HER2-ADC drugs, or ADC drugs with topoisomerase 1 inhibitors as the payload, or prior irinotecan therapy;
•3. History of severe cardiovascular or cerebrovascular diseases within the past 6 months before screening;
•4. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrollable arrhythmias;
•5. Concurrent pulmonary diseases resulting in severe impairment of lung function;
•6. History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment, or current ILD/interstitial pneumonia;
•7. Diagnosis of other primary malignancies within 3 years prior to the first dose;
•8. Poorly controlled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>100 mmHg);
•9. Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
•10. History of allergy to recombinant humanized antibodies or any excipient components of BL-M07D1;
+12 more criteria

Locations (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 24, 2025

Primary Completion Date

June 1, 2027

Completion Date

June 1, 2027

Last Updated

November 17, 2025

Enrollment

490

ESTIMATED participants

Conditions

Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Interventions

BL-M07D1

DRUG

Investigator's choice of chemotherapy

DRUG

Contacts

Sa Xiao, PHD

CONTACT

15013238943 xiaosa@baili-pharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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