Actively Recruiting
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
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-11-17
490
Participants Needed
2
Research Sites
87 weeks
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
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
Official 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 form and comply with the protocol requirements
- No gender restrictions
- Age between 18 and 75 years at the time of 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 as defined by RECIST v1.1
- ECOG performance status score of 0 or 1
- Recovery to Grade 1 or less toxicity from previous antitumor therapy as defined by NCI-CTCAE v5.0
- No severe cardiac dysfunction; left ventricular ejection fraction of 50% or higher
- Organ function levels meeting study requirements
- Coagulation function: INR of 1.5 or less and APTT of 1.5 times upper limit of normal or less
- Urine protein level of 2+ or less, or less than 1000 mg/24 hours
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start and not lactating
- All patients must use adequate barrier 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 prior to first dose, or major surgery, radical radiotherapy, immunotherapy within 4 weeks prior to first dose
- Previous treatment with HER2-ADC drugs, ADC drugs with topoisomerase 1 inhibitors, or irinotecan therapy
- History of severe cardiovascular or cerebrovascular diseases within 6 months before screening
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmias
- Severe pulmonary diseases impairing lung function
- History or current interstitial lung disease or interstitial pneumonia requiring steroid treatment
- Diagnosis of other primary cancers within 3 years prior to first dose
- Poorly controlled hypertension (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 requiring anticoagulant therapy
- Positive HIV antibody, active hepatitis B or C infection
- Severe infections within 4 weeks before first dose or requiring systemic treatment during screening
- Massive, symptomatic, or poorly controlled serous cavity effusions
- Long-term systemic corticosteroid therapy or immunosuppressive therapy within 2 weeks before randomization
- Severe neurological or psychiatric disorders
- Severe unhealed wounds, ulcers, or fractures within 4 weeks before consent
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Conditions like intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea
- Planned or recent (within 28 days) live vaccines
- Other severe physical or laboratory abnormalities, poor compliance, or factors increasing participation risk or interfering with study as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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