Actively Recruiting
A Phase II Clinical Trial to Evaluate the Efficacy and Safety 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
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 evaluating the efficacy and safety of a combination treatment using BL-B01D1 and PD-1 Monoclonal Antibody for patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma, and other solid tumors. This phase II clinical trial aims to explore how well this combination works and its safety profile in these patients. Participants receive BL-B01D1 and PD-1 Monoclonal Antibody through intravenous infusions every 3 weeks for the first cycle. Those who show clinical benefit may continue receiving additional treatment cycles. Treatment will be stopped if the disease progresses, intolerable side effects occur, or other reasons arise. During the study, participants will be monitored for tumor response using the Objective Response Rate and other measures over up to 24 months. Researchers will track progression-free survival, disease control, duration of response, and any treatment-related side effects. Participants will undergo regular assessments including imaging and lab tests to evaluate the effects of the treatment and its safety throughout the trial.
CONDITIONS
Brief 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...
- Voluntarily sign the informed consent form and agree to follow the study protocol
- Any gender
- Age 18 years or older
- Expected survival time of 3 months or more
- Diagnosed with locally advanced or metastatic non-small cell lung cancer or nasopharyngeal carcinoma confirmed by histopathology and/or cytology
- Able to provide 6-10 slides of archived tumor tissue or fresh tissue samples within 2 years
- Have at least one measurable lesion according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1
- Previous antineoplastic therapy toxicity recovered to grade 1 or less
- No serious cardiac dysfunction; left ventricular ejection fraction 50% or higher
- No blood transfusion or use of cell growth factors within 14 days before screening
- Coagulation function within specified limits (INR ≤1.5, APTT ≤1.5ULN)
- Urine protein level +2 or 1000 mg/24 h or less
- Negative pregnancy test for women of childbearing potential within 7 days before treatment, and non-lactating
- Agree to use effective 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 previous systemic therapy
- Patients with ALK fusion mutation identified before gene sequencing
- Use of anti-tumor therapy within 4 weeks or 5 half-lives before first dose; certain drugs within 6 weeks
- Serious heart disease or serious arrhythmias such as Long QT, complete left bundle branch block, or third-degree atrioventricular block
- Active autoimmune or inflammatory diseases
- Diagnosis of other malignant tumors within 5 years before first treatment
- Poorly controlled hypertension despite two antihypertensive drugs
- Poor glycemic control
- History or current interstitial lung disease
- Severe pulmonary disease causing respiratory impairment
- Large or symptomatic serous cavity effusions
- Tumor invading major blood vessels in chest, neck, or pharynx
- Unstable thrombotic events within 6 months before screening
- Active central nervous system disease
- Allergies to BL-B01D1 or its components
- Prior transplant or allogeneic stem cell transplantation
- Positive for HIV, active tuberculosis, or active hepatitis B or C infections
- Active infection requiring systemic therapy
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Participation in another clinical trial within 4 weeks before first dose
- Other conditions deemed inappropriate by the 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-B01D1 and PD-1 Monoclonal Antibody as intravenous infusions for cycles of 3 weeks. Those who benefit may continue treatment in additional 3-week cycles until disease progression, intolerable toxicity, or other reasons cause treatment to stop.
1 visit every 3 weeks for infusion
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 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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