Actively Recruiting
A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-08-06
40
Participants Needed
1
Research Sites
92 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 study is a multicenter, open-label, phase II clinical study to explore the safety and efficacy of BL-M07D1+PD-1 monoclonal antibody in patients with unresectable locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
CONDITIONS
Official Title
A Study of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agree to follow study requirements
- Any gender
- Age between 18 and 75 years at consent
- Expected survival of at least 3 months
- Pathologically confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma
- Willing to provide tumor tissue samples for biomarker analysis
- At least one measurable lesion by RECIST v1.1
- ECOG performance status 0 or 1
- Toxicity from prior cancer treatment recovered to grade 1 or less (NCI-CTCAE v5.0)
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- No blood transfusions within 14 days before first treatment; no colony-stimulating factors allowed
- Coagulation function within specified limits (INR ≤1.5 and APTT ≤1.5×ULN)
- Urine protein ≤2+ or ≤1000 mg/24h
- Use of effective contraception from 7 days before first dose to 7 months after dosing; negative pregnancy test for women of childbearing potential within 7 days before first dose
You will not qualify if you...
- Anti-tumor therapy (chemotherapy, biological therapy, immunotherapy) within 4 weeks or 5 half-lives before first dose
- Prior antibody-drug conjugate therapy with camptothecin derivative toxin
- Severe cardiovascular or cerebrovascular disease history in past 6 months
- Serious lung function impairment from pulmonary disease
- QT prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent uncontrolled arrhythmia
- Other primary cancers diagnosed within 5 years before first dose
- Poorly controlled hypertension
- History of interstitial lung disease needing steroids, current or suspected ILD/interstitial pneumonia
- Active central nervous system metastases
- Allergy to any trial drug components
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before dosing
- Large or symptomatic effusions or poorly controlled effusions
- Severe systemic infection within 4 weeks before screening
- Active autoimmune or inflammatory diseases
- Positive HIV antibody, active hepatitis B or C infection
- Previous allogeneic stem cell, bone marrow, or organ transplant
- Severe neurological or psychiatric illness history
- Pregnant or breastfeeding women
- Other serious health or lab abnormalities or poor compliance judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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