Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy 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 2025-09-26
121
Participants Needed
16
Research Sites
52 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
Researchers are evaluating the combination of BL-B01D1 and SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer, nasopharyngeal carcinoma, and other solid tumors. This Phase II study aims to explore how well this combination works, its safety, tolerability, and to determine the best dose and method for using these treatments together. The study focuses on patients with measurable tumors and specific health conditions suitable for this therapy. Participants receive both SI-B003 and the combination of BL-B01D1 with SI-B003 through intravenous infusions during the first 3-week treatment cycle. Those who show clinical benefits may continue to receive additional treatment cycles. Treatment will be stopped if the disease worsens, side effects become intolerable, or for other reasons determined by the study. During the study, participants will be closely monitored for tumor response, side effects, and overall disease control using specific criteria like tumor size changes. Assessments include imaging and safety evaluations conducted up to approximately 24 months. Researchers will measure outcomes such as objective response rate, progression-free survival, treatment-related adverse events, and determine the recommended dose for future studies. Participants' health and safety are carefully observed throughout the trial period.
CONDITIONS
Brief Title
A Study of SI-B003 and BL-B01D1+SI-B003 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 and agreement to follow protocol requirements
- Any gender
- Age between 18 and 75 years
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer or nasopharyngeal carcinoma
- Consent to provide archival or fresh tumor tissue samples within 2 years
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 or 1
- Previous antineoplastic therapy toxicity returned to grade 1 or less
- No severe cardiac dysfunction with left ventricular ejection fraction of 50% or higher
- No blood transfusion or use of growth factors within 14 days before study drug
- Coagulation function with INR 1.5 or less and aPTT 1.5 times upper limit of normal or less
- Urinary protein level of 2+ or less or 1000 mg/24h or less
- Negative pregnancy test for premenopausal women with childbearing potential and non-lactating
- Use of effective contraception during treatment and for 6 months after treatment ends
You will not qualify if you...
- Presence of MET 14 exon skipping detected by gene sequencing for stage 3 Cohort_A
- Use of chemotherapy, biological therapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks
- History of immunotherapy with grade 3 or higher immune-related adverse events or grade 2 or higher immune-related myocarditis
- Use of immunomodulatory drugs within 14 days before first dose
- History of severe heart disease
- QT prolongation, complete left bundle branch block, or third-degree atrioventricular block
- Need for systemic corticosteroids or immunosuppressive agents within 2 weeks before dosing
- Active autoimmune or inflammatory diseases
- Other malignancies diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two antihypertensive drugs
- Pulmonary disease grade 3 or higher or history of interstitial lung disease
- Unstable thrombotic events needing treatment within 6 months before screening
- Large or symptomatic serous cavity effusion within 4 weeks before consent
- Active central nervous system metastases
- Allergy to recombinant humanized antibody, human-mouse chimeric antibody, or study drug excipients
- Prior organ or allogeneic hematopoietic stem cell transplantation
- HIV positive, active tuberculosis, or active hepatitis B or C infection
- Active infections requiring systemic therapy
- Participation in another clinical trial within 4 weeks before first dose
- Investigator's judgment of unsuitability for trial participation
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 SI-B003 and BL-B01D1+SI-B003 by intravenous infusion in 3-week cycles. Those who have clinical benefit may receive additional treatment cycles until disease progression, intolerable toxicity, or other reasons.
1 visit per cycle (in-person)
Trial Site Locations
Total: 16 locations
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
2
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
4
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
5
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Not Yet Recruiting
6
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Not Yet Recruiting
7
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Not Yet Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
9
Union Hospital Tongji Medical College， Huazhong University of Science and Technology
Wuhan, Hubei, China
Not Yet Recruiting
10
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Not Yet Recruiting
11
Hunan Cancer Hospita
Changsha, Hunan, China
Not Yet Recruiting
12
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
13
Linyi Cancer Hospital
Linyi, Shangdong, China
Actively Recruiting
14
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Not Yet Recruiting
15
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
16
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet 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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