Actively Recruiting
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-05-06
570
Participants Needed
1
Research Sites
105 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 phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 Monoclonal Antibody in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma and other solid tumors.
CONDITIONS
Official Title
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form and agreed to follow study protocol
- Any gender
- 18 years old or older
- Expected survival time of at least 3 months
- Confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma by histopathology and/or cytology
- Able to provide 6-10 slides of archived tumor tissue or fresh tissue samples from primary or metastatic lesions within 2 years
- At least one measurable lesion according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Toxicity from previous cancer treatments returned to grade 1 or lower per NCI-CTCAE v5.0
- No serious heart dysfunction; left ventricular ejection fraction of 50% or higher
- No blood transfusion within 14 days before screening; no use of growth factors or platelet medicines; organ function meets study requirements
- Coagulation function with INR ≤ 1.5 and APTT ≤ 1.5 upper limit of normal
- Urine protein level +2 or 1000 mg/24h or less
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start and not breastfeeding
- All patients advised to use adequate barrier contraception during treatment and for 6 months after
You will not qualify if you...
- Stage 1 EGFR-sensitive mutant non-small cell lung cancer patients treated with systemic chemotherapy; stage 2 patients with prior systemic therapy
- Patients with ALK fusion mutations as indicated by gene sequencing report
- Anti-tumor therapies including chemotherapy or biological therapy within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks before first dose; oral fluorouracil drugs
- Serious heart disease
- Long QT syndrome, complete left bundle branch block, third-degree atrioventricular block, serious arrhythmia
- Active autoimmune or inflammatory diseases
- Other malignant tumors diagnosed within 5 years before first dose
- Poorly controlled hypertension requiring two antihypertensive drugs
- Poor glycemic control
- History or current interstitial lung disease or suspected during screening
- Severe respiratory impairment from pulmonary diseases
- Large or symptomatic serous cavity effusions or poorly controlled effusions
- Tumor involvement of large blood vessels in chest, neck, or pharynx as shown by imaging
- Unstable thrombotic events requiring treatment within 6 months before screening
- Active central nervous system disease
- Allergies to BL-B01D1 or related substances
- Prior transplant or allogeneic hematopoietic stem cell transplantation
- Positive for HIV antibody, active tuberculosis, active hepatitis B or C infections
- Active infection requiring systemic therapy
- Clinically significant bleeding or tendency within 4 weeks before consent
- Participation in another clinical trial within 4 weeks before first dose
- Other conditions deemed unsuitable 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 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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