Phase
Condition
Non-small Cell Lung Cancer
Nasopharyngeal Cancer
Carcinoma
Treatment
SI-B003
BL-B01D1
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sign the informed consent form voluntarily and follow the protocol requirements;
Gender is not limited;
Age: ≥18 years old and ≤75 years old;
Expected survival time ≥3 months;
Patients with histologically and/or cytologically confirmed locally advanced ormetastatic solid tumors such as non-small cell lung cancer and nasopharyngealcarcinoma;
Consent to provide archival tumor tissue samples or fresh tissue samples fromprimary or metastatic lesions within 2 years;
At least one measurable lesion meeting the RECIST v1.1 definition was required;
ECOG 0 or 1;
The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as definedby NCI-CTCAE v5.0;
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
No blood transfusion, no use of cell growth factors and/or platelet raising drugswithin 14 days before the first use of the study drug, and the level of organfunction must meet the requirements;
Coagulation function: international normalized ratio ≤1.5, and activated partialthromboplastin time≤1.5 ULN;
Urinary protein ≤2+ or ≤1000mg/24h;
For premenopausal women with childbearing potential, a pregnancy test must beperformed within 7 days before starting treatment, serum or urine must be negativefor pregnancy, and must be non-lactating; All enrolled patients (male or female)were advised to use adequate barrier contraception throughout the treatment cycleand for 6 months after the end of treatment.
Exclusion
Exclusion Criteria:
For stage 3 Cohort_A, patients with MET 14 exon skipping detected by gene sequencingreport before signing informed consent;
Chemotherapy, biological therapy and other anti-tumor therapies have been usedwithin 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureaswere administered within 6 weeks before the first dose; Oral drugs such asfluorouracil;
Had received immunotherapy and developed ≥ grade 3 irAE or ≥ grade 2 immune-relatedmyocarditis;
Use of immunomodulatory drugs within 14 days before the first dose of study drug;
History of severe heart disease;
QT prolongation, complete left bundle branch block, III degree atrioventricularblock;
Systemic corticosteroids or immunosuppressive agents are required within 2 weeksbefore study dosing;
Active autoimmune and inflammatory diseases;
Other malignancies diagnosed within 5 years before the first dose;
Hypertension poorly controlled by two antihypertensive drugs;
Pulmonary disease was defined as grade ≥3 according to CTCAE v5.0; Patients withcurrent or history of ILD;
Unstable thrombotic events requiring therapeutic intervention within 6 months beforescreening;
Patients with a large amount of serous cavity effusion, or serous cavity effusionwith symptoms, or within 4 weeks before signing informed consent;
Patients with active central nervous system metastases;
Patients with a history of allergy to recombinant humanized antibody or human-mousechimeric antibody or to any excipients of the test drug;
Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
Human immunodeficiency virus antibody positive, active tuberculosis, activehepatitis B virus infection or hepatitis C virus infection;
Active infection requiring systemic therapy;
Had participated in another clinical trial within 4 weeks before the first dose;
The investigator did not consider it appropriate to use other conditions forparticipation in the trial.
Study Design
Study Description
Connect with a study center
Chongqing University Cancer Hospital
Chongqing, Chongqing
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou, Fujian
ChinaSite Not Available
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
ChinaSite Not Available
Liuzhou People's Hospital
Liuzhou, Guangxi
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan
ChinaSite Not Available
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
ChinaSite Not Available
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
ChinaSite Not Available
Hunan Cancer Hospita
Changsha, Hunan
ChinaSite Not Available
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
ChinaSite Not Available
Linyi Cancer Hospital
Linyi, Shangdong
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shanxi
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, Tianjin
ChinaSite Not Available
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
ChinaSite Not Available
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