| Eligibility |
Inclusion Criteria:
- Age 18 to 75 years old of either gender;
- Standard treatment failure, or no standard treatment, or subjects with advanced
malignant solid tumors diagnosed by histology or cytology that are not suitable for
standard treatment at this stage; there is no limit to the number of treatment options
before enrollment;
- Anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine
therapy or immunotherapy was not received within 4 weeks before the first treatment of
HB002.1T. Mitomycin and nitrosourea were administered for 6 weeks, fluorouracil Oral
medications such as tega, capecitabine for at least 2 weeks from the last dose;
- At least one evaluable lesion according to RECIST 1.1;
- ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1
- The expected survival period is not less than 12 weeks;
- The organ function indicated by the following laboratory indicators must be met:
1. No growth factor support therapy within 14 days, absolute neutrophil count
=1.5E+9/L;
2. No transfusion support therapy or growth factor therapy within 14 days ,
hemoglobin = 90g/L;
3. Platelet count = 100E+9/L;
4. Serum creatinine = 1.5 × upper limit of normal (ULN), or creatinine clearance =
60mL / min (serum creatinine > 1.5 × ULN);
5. Total bilirubin = 1.5 × ULN;
6. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
concentrations = 2.5 × ULN, or when elevated due to tumor liver metastasis, ALT
and AST = 5 × ULN as judged by the investigator;
7. Electrolyte: blood potassium = 3.0 mmol/L; blood calcium = 2.0 mmol/L;
8. Prothrombin time (PT) = 1.2 × ULN;
9. Partial promotion prothrombin time (APTT) = 1.2 × ULN;
10. Urine test paper test results show that urine protein < 1 +, if = 1 +, need to
meet the 24-hour urine protein content <1g.
- The toxicity of previous treatment has been restored to NCI CTCAE = 1 (except for hair
loss);
- Women and men of childbearing age must agree to take effective contraceptive measures
after signing informed consent, during the study period and within 3 months after the
last dose of HB002.1T, and the results of the pregnancy test for women of childbearing
age must be negative;
- Subjects must voluntarily sign written informed consent;
- Subjects are able to communicate well with the investigator and are able to comply
with research regulations.
Exclusion Criteria:
- Patients with confirmed active central nervous system metastasis and/or cancerous
meningitis; but patients with central nervous system metastases who have received
treatment and achieved clinical stability for 3 months before starting the study can
be enrolled;
- A history of infection with human immunodeficiency virus, or other acquired,
congenital disease, or history of organ transplantation;
- Active hepatitis B patients (viral titer is above the upper limit of detection); or
hepatitis C virus infection;
- Subjects who have previously been allergic to macromolecular protein
preparations/monoclonal antibodies, or known to be allergic to any of the test drug
components or excipients;
- Those who have received other clinical trial drugs within 4 weeks before the first
treatment of HB002.1T;
- Those who have undergone major surgery within 4 weeks prior to screening;
- Minor surgical procedures (including catheterization, no peripheral venous puncture
central catheterization) within 2 days prior to screening; venous puncture center
catheterization);
- Patients with systolic blood pressure =140mmHg and/or diastolic blood pressure or
diastolic blood pressure =90mmHg after antihypertensive treatment (one
antihypertensive drug is allowed in the baseline period, and the compound preparation
is recognized as two);
- The subject has an active infection or during the screening period, the unexplained
fever occurs before the first dose > 38.5 °C;
- Those who have had hemoptysis within 4 weeks before screening (defined as coughing
with =1 teaspoon of blood), but do not rule out cough only with sputum or small blood
clot;
- Subjects suffering from the following serious complications:
1. Unstable angina and/or congestive heart failure or vascular disease requiring
hospitalization within 12 months (eg, aortic aneurysm peripheral thrombectomy),
or vascular disease (eg, aorta requiring surgical repair) Peripheral static
thrombus), other heart damage that the investigator judges is not suitable for
clinical trials (eg, poorly controlled arrhythmias, muscle infarction, etc.);
2. Prior arterial thromboembolic events, venous thrombosis above the venous
thrombosis of grade 3 or higher in NCI CTCAE, transient ischemic attack (TIA),
cerebral vascular accident (CVA), transmural Myocardial infarction), transmural
myocardial infarction, myocardial infarction (MI), hypertensive crisis or
encephalopathy; hypertensive crisis or encephalopathy; ), hypertensive crisis or
encephalopathy;
3. Previous or current persistent fulminant hemorrhagic disease;
4. Chronic Obstructive Pulmonary Disease (COPD) or other respiratory illness
requiring hospitalization within 4 weeks prior to screening;
5. History of abdominal hernia, gastrointestinal perforation abscess or acute
bleeding in the first 6 months prior to screening;
6. Esophageal varices, unhealed wounds or fractures within 6 months prior to
screening;
7. Dominant jaundice and/or caused by abnormal liver function
- Subjects who are in use of warfarin, heparin aspirin (>325 mg/day) or other drugs
known to inhibit platelet function within 10 days prior to the first study treatment;
- Subjects receiving dipyridamole, ticlopidine, clopidogrel or cilostazol treatment;
- Subjects with a clear history of neurological or dysfunction, such as poor adherence
to epilepsy;
- Pregnant or nursing women;
- Any other reasons assessed by the investigator that are not suitable for participation
in the trial.
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