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The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T, a human immunoglobulin Fc fusion protein containing domain 2 and flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB002.1T 2mg/kg | Experimental | Participants received a 2mg/kg dose of HB002.1T via intravenous injection. |
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| HB002.1T 4mg/kg | Experimental | Participants received a 4mg/kg dose of HB002.1T via intravenous injection. |
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| HB002.1T 8mg/kg | Experimental | Participants received a 8mg/kg dose of HB002.1T via intravenous injection. |
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| HB002.1T 12mg/kg | Experimental | Participants received a 12mg/kg dose of HB002.1T via intravenous injection. |
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| HB002.1T 16mg/kg | Experimental | Participants received a 16mg/kg dose of HB002.1T via intravenous injection. |
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| HB002.1T 20mg/kg | Experimental | Participants received a 20mg/kg dose of HB002.1T via intravenous injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB002.1T | Drug | HB002.1T is a Vascular Endothelial Growth Factor Receptor Decoy |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities | Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities | 21 days after the first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Titer and detection rate of anti drug antibody | Titer and detection rate of anti drug antibody | 1,8,15,and 21 days after the first treatment, at the end of each treatment cycle (cycle 1 is 21 days, cycle 2 to 5 is 14 days) , and and up to 28 days after last treatment |
| Objective Response Rate |
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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:
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:
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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200123 | China |
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Objective response rate |
| 7 days before first treatment, at the end of treatment cycle 4 and cycle 5 (cycle 1 is 21 days, cycle 2 to 5 is 14 days) |
| Disease Control Rate | Disease control rate | 7 days before first treatment, at the end of treatment cycle 4 and cycle 5 (cycle 1 is 21 days, cycle 2 to 5 is 14 days) |
| Computed Tomography | Computed tomography examination | 7 days before first treatment, at the end of treatment cycle 4 and cycle 5 (cycle 1 is 21 days, cycle 2 to 5 is 14 days) |
| Peak Plasma Concentration | Peak plasma concentration of patients | 1,8,15,and 21 days after the first treatment, at the end of each treatment cycle (cycle 1 is 21 days, cycle 2 to 5 is 14 days) , and and up to 28 days after last treatment |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Area under the plasma concentration versus time curve (AUC) of patients | 1,8,15,and 21 days after the first treatment, at the end of each treatment cycle (cycle 1 is 21 days, cycle 2 to 5 is 14 days) , and and up to 28 days after last treatment |