Actively Recruiting
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-08-22
31
Participants Needed
1
Research Sites
122 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 an open-label, multicenter, dose-escalation and cohort-expansion, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors.
CONDITIONS
Official Title
A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer and Other Solid Tumors
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 18 years or older and up to 75 years (Phase Ia); 18 years or older (Phase Ib)
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer or other solid tumors that have failed standard treatment
- Willing to provide archived or fresh tumor tissue samples from primary or metastatic lesions within the past 2 years
- Must have at least one measurable lesion as defined by RECIST v1.1
- ECOG performance status score of 0 or 1
- Toxicities from prior anti-tumor therapy have recovered to Grade 1 or less as defined by NCI-CTCAE v5.0
- No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) 50% or higher
- Organ function levels must meet the requirements
- Coagulation function: International Normalized Ratio (INR) 1.5 or less, and activated partial thromboplastin time (APTT) 1.5 times upper limit of normal or less
- Urine protein 2+ or less or 1000mg/24h or less
- For premenopausal women with childbearing potential, a negative serum pregnancy test within 7 days before starting treatment, and not breastfeeding
- All patients must use adequate barrier contraception throughout treatment and for 6 months after treatment
- Ability and willingness to comply with visits, treatment plans, laboratory tests, and other study-related procedures
You will not qualify if you...
- Received chemotherapy, biological therapy, immunotherapy, or similar treatments within 4 weeks or 5 half-lives before the first dose
- History of severe cardiac disease
- Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Diagnosed with another malignancy within 5 years before the first dose (except certain cured skin or cervical cancers)
- Unstable thrombotic events requiring treatment within 6 months before the first dose
- Poorly controlled hypertension or diabetes mellitus
- History of interstitial lung disease requiring steroid therapy, current ILD, or grade 2 or higher radiation pneumonitis
- Concurrent severe pulmonary diseases causing respiratory impairment
- Active central nervous system metastases
- History of allergy or hypersensitivity to humanized or chimeric antibodies or to BL-M09D1 components
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
- High cumulative dose of anthracyclines (>360 mg/m2) in prior therapy
- Positive for HIV antibody, active tuberculosis, hepatitis B or C infections
- Active infections requiring systemic treatment within 4 weeks before first drug administration
- Pleural, peritoneal, pelvic, or pericardial effusion requiring drainage or symptomatic within 4 weeks before first drug administration
- Participation in another clinical trial within 4 weeks or 5 half-lives before first dose
- Pregnant or lactating women
- Other conditions deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
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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