Actively Recruiting
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-03-05
80
Participants Needed
1
Research Sites
95 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 multicenter, open-label, Phase II clinical study to explore the efficacy and safety of BL-M07D1 in combination with pembrolizumab in patients with locally advanced or metastatic HER2-overexpressing non-squamous non-small cell lung cancer.
CONDITIONS
Official 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 at the time of signing informed consent
- Expected survival time of at least 3 months
- Locally advanced or metastatic non-squamous non-small cell lung cancer
- Confirmed known HER2 overexpression
- Agree to provide archived tumor tissue specimens from primary or metastatic lesions within the past 2 years
- At least one measurable lesion according to RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Toxicities from prior anti-tumor treatments have recovered to Grade 1 or less as defined by NCI-CTCAE v5.0
- No severe cardiac dysfunction, with left ventricular ejection fraction of 50% or higher
- Organ function levels meeting study requirements
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment, not breastfeeding, and agreeing to use effective contraception throughout treatment and for 7 months after treatment ends
You will not qualify if you...
- Underwent surgical treatment, radical radiotherapy, immunotherapy, or similar within 4 weeks before first dose or within 5 half-lives
- Pathology showing non-small cell carcinoma with small cell carcinoma or sarcomatoid carcinoma components
- Prior treatment with HER2-targeted therapy or ADC drugs with camptothecin derivatives
- History of severe cardiovascular or cerebrovascular disease within 6 months before screening
- Severe lung disease impairing lung function
- QT interval prolongation, complete left bundle branch block, third-degree atrioventricular block, or frequent uncontrollable arrhythmias
- Diagnosed with other primary cancers within 5 years before first dose
- Poorly controlled hypertension
- History of non-infectious interstitial lung disease requiring steroids or current interstitial lung disease
- Central nervous system metastases, carcinomatous meningitis, or spinal cord compression
- Allergy to recombinant humanized antibodies, BL-M07D1, pembrolizumab, or any excipients
- Required systemic corticosteroids or immunosuppressive therapy within 2 weeks before study
- Massive, symptomatic, or poorly controlled serous cavity effusion
- New deep vein thrombosis within 14 days (except with venous filters)
- Severe systemic infection within 4 weeks before screening
- Active autoimmune or inflammatory diseases
- HIV antibody positivity or active hepatitis B or C infections
- History of allogeneic stem cell, bone marrow, or organ transplantation
- Severe neurological or psychiatric disorders
- Other severe physical or laboratory abnormalities, poor compliance, or conditions increasing risk or interfering with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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