Actively Recruiting
A Phase III Randomized Controlled Study of BL-M07D1 Injection versus Investigator's Choice of Chemotherapy in Patients with HER2-positive Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma After First-line Anti-HER2 Therapy Failure
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-11-17
490
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BL-M07D1 in adults aged 18 to 75 with HER2-positive locally advanced or metastatic gastric or gastro-esophageal junction adenocarcinoma. This phase III, randomized, controlled, open-label, multicenter trial focuses on patients who have not responded to first-line anti-HER2 therapy and standard chemotherapy. The study aims to compare BL-M07D1 to investigator's choice of chemotherapy after treatment failure. Participants are randomly assigned to receive either BL-M07D1 administered by intravenous infusion in 3-week cycles or chemotherapy chosen by the investigator, given by intravenous infusion in 2 to 4-week cycles. Treatment continues for additional cycles if clinical benefit is observed, but administration will stop if the disease progresses, intolerable side effects occur, or for other reasons. The study evaluates both treatment options over a period of up to 24 months. During the trial, participants undergo assessments to monitor overall survival and progression-free survival as primary outcomes, along with secondary measures such as response rates, disease control, treatment side effects, and immune responses. Safety monitoring includes tracking adverse events and antibody formation against the drug. Participants are followed closely throughout the treatment period with evaluations conducted regularly to assess treatment impact and tolerability.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent and agree to follow the study rules
- No gender restrictions
- Aged 18 to 75 years at consent
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
- At least one measurable target lesion per RECIST v1.1
- ECOG performance status score of 0 or 1
- Toxicity from prior cancer treatments recovered to Grade 1 or less (NCI-CTCAE v5.0)
- No severe heart dysfunction; left ventricular ejection fraction at least 50%
- Adequate organ function
- Coagulation function with INR ≤1.5 and APTT ≤1.5 times upper limit of normal
- Urine protein level 2+ or less and less than 1000 mg/24h
- For premenopausal women with childbearing potential: negative pregnancy test within 7 days before treatment start; not breastfeeding
- Use effective contraception during treatment and for 7 months after treatment ends
You will not qualify if you...
- Chemotherapy with mitomycin C or nitrosoureas within 6 weeks before first dose
- Major surgery, radical radiotherapy, immunotherapy, or similar within 4 weeks before first dose
- Previous treatment with HER2-ADC drugs, ADC drugs with topoisomerase 1 inhibitors, or irinotecan therapy
- Severe cardiovascular or cerebrovascular disease within 6 months before screening
- Prolonged QT interval, complete left bundle branch block, third-degree AV block, or frequent uncontrollable arrhythmias
- Severe lung diseases impairing lung function
- History or current interstitial lung disease or pneumonia requiring steroid treatment
- Other primary cancers diagnosed within 3 years before first dose
- Poorly controlled high blood pressure (systolic >150 mmHg or diastolic >100 mmHg)
- Central nervous system metastases or carcinomatous meningitis
- Allergy to recombinant humanized antibodies or BL-M07D1 components
- History of stem cell transplantation
- Unstable or recent deep vein thrombosis
- Positive HIV antibody or active hepatitis B or C infection
- Severe infections within 4 weeks before first dose
- Large or poorly controlled fluid buildup in body cavities
- Long-term corticosteroid or immunosuppressive therapy within 2 weeks before randomization
- Severe neurological or psychiatric disorders
- Serious unhealed wounds, ulcers, or fractures within 4 weeks before consent
- Significant bleeding or bleeding disorders within 4 weeks before consent
- Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Planned or recent live vaccinations within 28 days before first dose
- Other serious health or lab problems, poor compliance, or factors increasing study risk or affecting results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive either BL-M07D1 or investigator's choice of chemotherapy by intravenous infusion in cycles. The first cycle lasts 3 weeks, and participants with clinical benefit may continue additional cycles until disease progression, intolerable toxicity, or other reasons for stopping treatment.
1 visit per cycle (in-person)
Trial Site Locations
Total: 2 locations
1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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