Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous Non-Small Cell Lung Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-03-05
80
Participants Needed
1
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 investigating the safety and effectiveness of combining BL-M07D1 with pembrolizumab in patients who have locally advanced or metastatic non-squamous non-small cell lung cancer that overexpresses HER2. This Phase II, open-label, multicenter study aims to better understand how these treatments work together in this specific patient group. Participants receive BL-M07D1 and pembrolizumab through intravenous infusions every three weeks. Those who show clinical benefit may continue with additional treatment cycles. Treatment will stop if the disease progresses, if side effects become intolerable, or for other reasons determined by the study team. During the study, patients will be closely monitored for treatment response using measures like the objective response rate, progression-free survival, and overall survival over about 24 months. Researchers will also track drug levels, immune responses, and any side effects. Participants will have regular assessments to ensure safety and evaluate how well the combination treatment works.
CONDITIONS
Brief Title
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC
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
- Expected survival time of at least 3 months
- Have locally advanced or metastatic non-squamous non-small cell lung cancer
- Confirmed HER2 overexpression
- Willing to provide archived tumor tissue specimens from the past 2 years
- Have at least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Toxicities from prior anti-tumor treatments recovered to Grade 1 or less
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- Meet organ function requirements
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment and not breastfeeding
- All patients must use effective contraception during treatment and for 7 months after treatment ends
You will not qualify if you...
- Had surgery, radical radiotherapy, immunotherapy, or similar treatments within 4 weeks before the first dose or within 5 half-lives
- Pathology showing small cell or sarcomatoid components
- Prior HER2-targeted therapy or ADC drug treatment with camptothecin derivatives
- Severe cardiovascular or cerebrovascular disease within 6 months before screening
- Pulmonary disease causing severe lung function impairment
- Heart conduction problems like QT prolongation, left bundle branch block, complete heart block, or uncontrollable arrhythmias
- Other primary cancers diagnosed within 5 years before first dose
- Poorly controlled high blood pressure
- History or current interstitial lung disease requiring steroids
- Central nervous system metastases or related complications
- Allergy to recombinant humanized antibodies or study drugs
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before study
- Significant or uncontrolled serous cavity effusions
- New deep vein thrombosis within 14 days (except with venous filters)
- Severe infection within 4 weeks before screening
- Active autoimmune or inflammatory diseases
- HIV antibody positive or active hepatitis B or C infection
- History of stem cell, bone marrow, or organ transplantation
- Severe neurological or psychiatric disorders
- Other severe physical or laboratory abnormalities, poor compliance, or deemed unsuitable by 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 BL-M07D1 and pembrolizumab by intravenous infusion in 3-week cycles. Participants who have a clinical benefit may receive additional cycles until disease progression, intolerable toxicity, or other reasons for discontinuation.
1 visit every 3 weeks for drug administration
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
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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