Clinical Trials/NCT03636750

NCT03636750

Completed

Phase 1

A Phase 1, Safety, Tolerability and Pharmacokinetic Profile Study of Intravenous Injections of HB002.1T (a Vascular Endothelial Growth Factor Receptor Decoy) in Subjects With Solid Tumor

Huabo Biopharm Co., Ltd.1 site in 1 country27 target enrollmentJune 28, 2018

ConditionsSolid Tumor

InterventionsHB002.1T

DrugsHB002.1T

Overview

Phase: Phase 1
Intervention: HB002.1T
Conditions: Solid Tumor
Sponsor: Huabo Biopharm Co., Ltd.
Enrollment: 27
Locations: 1
Primary Endpoint: Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 28, 2018

End Date

March 21, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huabo Biopharm Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•No growth factor support therapy within 14 days, absolute neutrophil count ≥1.5E+9/L;
•No transfusion support therapy or growth factor therapy within 14 days , hemoglobin ≥ 90g/L;
•Platelet count ≥ 100E+9/L;

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;

Arms & Interventions

HB002.1T 2mg/kg

Participants received a 2mg/kg dose of HB002.1T via intravenous injection.

Intervention: HB002.1T

HB002.1T 4mg/kg

Participants received a 4mg/kg dose of HB002.1T via intravenous injection.

Intervention: HB002.1T

HB002.1T 8mg/kg

Participants received a 8mg/kg dose of HB002.1T via intravenous injection.

Intervention: HB002.1T

HB002.1T 12mg/kg

Participants received a 12mg/kg dose of HB002.1T via intravenous injection.

Intervention: HB002.1T

HB002.1T 16mg/kg

Participants received a 16mg/kg dose of HB002.1T via intravenous injection.

Intervention: HB002.1T

HB002.1T 20mg/kg

Participants received a 20mg/kg dose of HB002.1T via intravenous injection.

Intervention: HB002.1T

Outcomes

Primary Outcomes

Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities

Time Frame: 21 days after the first treatment

Dose-limiting toxicity (DLT) defined as grade 3 or higher National Cancer Institute - Common Terminology Criteria (NCI-CTC) toxicities

Secondary Outcomes

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(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(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(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(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)(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)