Actively Recruiting
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
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
121
Participants Needed
16
Research Sites
200 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
Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.
CONDITIONS
Official 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 agree 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 including non-small cell lung cancer and 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
- Toxicity from previous cancer treatments has returned to grade 1 or less per NCI-CTCAE v5.0
- No severe heart dysfunction; left ventricular ejection fraction at least 50%
- No blood transfusion or use of growth factors within 14 days before starting study drug
- Coagulation parameters within defined limits (INR ≤1.5, aPTT ≤1.5 ULN)
- Urinary protein ≤2+ or ≤1000 mg/24h
- For premenopausal women with childbearing potential, negative pregnancy test within 7 days before treatment start and not breastfeeding
- All patients advised to use effective contraception during treatment and for 6 months after
You will not qualify if you...
- For Stage 3 Cohort_A, presence of MET 14 exon skipping mutation detected by gene sequencing
- 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; oral fluorouracil drugs
- 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
- Heart rhythm issues including QT prolongation, complete left bundle branch block, or third-degree atrioventricular block
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before dosing
- Active autoimmune or inflammatory diseases
- Other cancers diagnosed within 5 years before first dose
- Poorly controlled hypertension despite two medications
- Severe pulmonary disease (grade 3 or higher) or history of interstitial lung disease
- Unstable thrombotic events requiring treatment within 6 months before screening
- Large or symptomatic serous cavity effusions or effusions within 4 weeks before consent
- Active central nervous system metastases
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any study drug components
- Prior organ or stem cell transplantation
- Positive for HIV, active tuberculosis, hepatitis B or C infections
- Active infections requiring systemic therapy
- Participation in another clinical trial within 4 weeks before first dose
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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