Trial 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
NCT ID:
NCT05956587
Condition:
Non-small Cell Lung Cancer
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
SI-B003
Description:
Administration by intravenous infusion
Arm group label:
Study treatment
Summary:
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.
Detailed description:
Phase II: To explore the efficacy of BL-B01D1+SI-B003 combination in patients with
locally advanced or metastatic solid tumors such as non-small cell lung cancer and
nasopharyngeal carcinoma. To explore the safety and tolerability of BL-B01D1+SI-B003
combination 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age: ≥18 years old and ≤75 years old;
4. Expected survival time ≥3 months;
5. Patients with histologically and/or cytologically confirmed locally advanced or
metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal
carcinoma;
6. Consent to provide archival tumor tissue samples or fresh tissue samples from
primary or metastatic lesions within 2 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. ECOG 0 or 1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. No blood transfusion, no use of cell growth factors and/or platelet raising drugs
within 14 days before the first use of the study drug, and the level of organ
function must meet the requirements;
12. Coagulation function: international normalized ratio ≤1.5, and activated partial
thromboplastin time≤1.5 ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be
performed within 7 days before starting treatment, serum or urine must be negative
for pregnancy, and must be non-lactating; All enrolled patients (male or female)
were advised to use adequate barrier contraception throughout the treatment cycle
and for 6 months after the end of treatment.
Exclusion Criteria:
1. For stage 3 Cohort_A, patients with MET 14 exon skipping detected by gene sequencing
report before signing informed consent;
2. Chemotherapy, biological therapy and other anti-tumor therapies have been used
within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas
were administered within 6 weeks before the first dose; Oral drugs such as
fluorouracil;
3. Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-related
myocarditis;
4. Use of immunomodulatory drugs within 14 days before the first dose of study drug;
5. History of severe heart disease;
6. QT prolongation, complete left bundle branch block, III degree atrioventricular
block;
7. Systemic corticosteroids or immunosuppressive agents are required within 2 weeks
before study dosing;
8. Active autoimmune and inflammatory diseases;
9. Other malignancies diagnosed within 5 years before the first dose;
10. Hypertension poorly controlled by two antihypertensive drugs;
11. Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients with
current or history of ILD;
12. Unstable thrombotic events requiring therapeutic intervention within 6 months before
screening;
13. Patients with a large amount of serous cavity effusion, or serous cavity effusion
with symptoms, or within 4 weeks before signing informed consent;
14. Patients with active central nervous system metastases;
15. Patients with a history of allergy to recombinant humanized antibody or human-mouse
chimeric antibody or to any excipients of the test drug;
16. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
17. Human immunodeficiency virus antibody positive, active tuberculosis, active
hepatitis B virus infection or hepatitis C virus infection;
18. Active infection requiring systemic therapy;
19. Had participated in another clinical trial within 4 weeks before the first dose;
20. The investigator did not consider it appropriate to use other conditions for
participation in the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaolei Shu
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wu Zhuang
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Zhang
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoming Huang
Facility:
Name:
The First Affiliated Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yong Chen
Facility:
Name:
Liuzhou People's Hospital
Address:
City:
Liuzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhanxiong Luo
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiye Zhang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanqiu Zhao
Facility:
Name:
Union Hospital Tongji Medical College， Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kunyu Yang
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Conghua Xie
Contact backup:
Last name:
Yahua Zhong
Facility:
Name:
Hunan Cancer Hospita
Address:
City:
Changsha
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yaqian Han
Facility:
Name:
The Second Affiliated Hospital Of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Xu
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Wang
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiao Tong University
Address:
City:
Xi'an
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yi Yao
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Diansheng Zhong
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yun Fan
Start date:
January 29, 2024
Completion date:
November 2025
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05956587
