BL-M07D1 combined with a PD-1 antibody for unresectable or metastatic HER2-positive stomach or gastroesophageal junction cancer

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

This study will test whether combining BL-M07D1 with a PD‑1 antibody is safe and can help adults with HER2‑positive stomach or gastroesophageal junction cancer that cannot be removed by surgery or has spread.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06423885 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open‑label phase II trial testing the combination of BL‑M07D1 and a PD‑1 monoclonal antibody in patients with unresectable locally advanced or metastatic HER2‑positive gastric or gastroesophageal junction adenocarcinoma. Eligible adults must have pathologically confirmed HER2‑positive disease, at least one measurable lesion by RECIST v1.1, ECOG performance status 0–1, and adequate organ and cardiac function. Participants will receive the combination therapy and be monitored for safety, tumor response, and survival outcomes, with tumor tissue collected when possible for exploratory biomarker analyses (including HER2 and PD‑L1). The study excludes patients with significant cardiac dysfunction, recent blood transfusion, or unresolved high‑grade toxicity from prior therapies.

Who should consider this trial

Good fit: Adults aged 18–75 with pathologically confirmed unresectable locally advanced or metastatic HER2‑positive gastric or gastroesophageal junction adenocarcinoma, at least one measurable lesion, ECOG 0–1, and adequate organ and cardiac function are ideal candidates.

Not a fit: Patients who are not HER2‑positive, have ECOG ≥2, significant cardiac dysfunction, recent blood transfusion, or unresolved high‑grade toxicity from prior treatments are unlikely to benefit from this combination.

Why it matters

Potential benefit: If successful, the combination could shrink tumors or slow disease progression and provide a new treatment option for patients with advanced HER2‑positive gastric or GE junction cancer.

How similar studies have performed: Other trials combining HER2‑targeted therapy with PD‑1 blockade have shown encouraging response rates, but the specific BL‑M07D1 combination is novel and less extensively studied.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
4. Expected survival time ≥3 months;
5. Patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma confirmed by pathology;
6. Patients provided tumor tissue specimens as far as possible for the detection of biomarkers such as HER2 and PD-L1 for exploratory retrospective analysis;
7. Must have at least one measurable lesion according to RECIST v1.1 definition;
8. ECOG 0 or 1;
9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Blood transfusion is not allowed within 14 days before the first use of study drugs, and the use of colony-stimulating factors is not allowed, and the organ function level must meet the requirements;
12. Coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5×ULN;
13. Urine protein ≤2+ or ≤1000mg/24h;
14. Female subjects of childbearing potential, or male subjects with a fertile partner, had to use highly effective contraception from 7 days before the first dose until 7 months after the dose. Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose.

Exclusion Criteria:

1. Anti-tumor therapy such as chemotherapy, biological therapy, and immunotherapy had been used within 4 weeks or 5 half-lives before the first dose. Oral drugs such as fluorouracil;
2. Prior ADC drug therapy with camptothecin derivative as toxin;
3. The history of severe cardiovascular and cerebrovascular diseases in the past six months;
4. Serious impairment of lung function due to pulmonary diseases;
5. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
6. Other primary malignancies diagnosed within 5 years before the first dose;
7. Poorly controlled hypertension;
8. A history of ILD requiring steroid therapy, current ILD/interstitial pneumonia or suspected to have such a condition during screening;
9. Patients with active central nervous system metastases;
10. Patients who are allergic to any excipients of the trial drug;
11. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before study dosing;
12. Patients with massive or symptomatic effusions or poorly controlled effusions;
13. Severe systemic infection within 4 weeks before screening;
14. Active autoimmune and inflammatory diseases;
15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
16. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
17. A history of severe neurological or psychiatric illness;
18. Pregnant or lactating women;
19. The presence of other serious physical or laboratory abnormalities or poor compliance may increase the risk of participating in the study risk, or interference with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Weijian Guo — Fudan University
• Study coordinator: Sa Xiao, PHD

Conditions HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma