Solid TumorPhase 1NCT03636750

A Study of Injection HB002.1T in Subjects With Solid Tumor

A Phase 1 study testing HB002.1T in people with Solid Tumor, run by Huabo Biopharm Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Solid Tumor
What is being tested?: HB002.1T
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteChina
Study dates: 28 Jun 2018to 21 Mar 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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;
Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60mL / min (serum creatinine > 1.5 × ULN);
Total bilirubin ≤ 1.5 × ULN;
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;
Electrolyte: blood potassium ≥ 3.0 mmol/L; blood calcium ≥ 2.0 mmol/L;
Prothrombin time (PT) ≤ 1.2 × ULN;
Partial promotion prothrombin time (APTT) ≤ 1.2 × ULN;
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.

Who cannot join

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;

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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:
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.);
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;
Previous or current persistent fulminant hemorrhagic disease;
Chronic Obstructive Pulmonary Disease (COPD) or other respiratory illness requiring hospitalization within 4 weeks prior to screening;
History of abdominal hernia, gastrointestinal perforation abscess or acute bleeding in the first 6 months prior to screening;
Esophageal varices, unhealed wounds or fractures within 6 months prior to screening;
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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

Official title: 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

Conditions: Solid Tumor
Being tested: HB002.1T

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HB002.1TDrug
HB002.1T is a Vascular Endothelial Growth Factor Receptor Decoy

Study groups in NCT03636750
Study group	Role	What they receive
HB002.1T 2mg/kg	Experimental	Participants received a 2mg/kg dose of HB002.1T via intravenous injection. Receives: Drug: HB002.1T
HB002.1T 4mg/kg	Experimental	Participants received a 4mg/kg dose of HB002.1T via intravenous injection. Receives: Drug: HB002.1T
HB002.1T 8mg/kg	Experimental	Participants received a 8mg/kg dose of HB002.1T via intravenous injection. Receives: Drug: HB002.1T
HB002.1T 12mg/kg	Experimental	Participants received a 12mg/kg dose of HB002.1T via intravenous injection. Receives: Drug: HB002.1T
HB002.1T 16mg/kg	Experimental	Participants received a 16mg/kg dose of HB002.1T via intravenous injection. Receives: Drug: HB002.1T
HB002.1T 20mg/kg	Experimental	Participants received a 20mg/kg dose of HB002.1T via intravenous injection. Receives: Drug: HB002.1T

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 21 days after the first treatment

Secondary outcomes (6)

Titer and detection rate of anti drug antibody
Titer and detection rate of anti drug antibody
Measured: 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
Objective response rate
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201821 Mar 2020

First posted17 Aug 2018
Study start28 Jun 2018
Primary completion20 Feb 2020
Study completion21 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03636750
Sponsor's protocol ID: HB002.1T-01
Status last verified: Jul 2021
First submitted: 6 Aug 2018
Last updated: 28 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03636750
Acronym / sponsor ID: HB002.1T-01
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
Study start: 28 Jun 2018 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 21 Mar 2020 (actual)
First posted: 17 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
HB002.1T 2mg/kg	Experimental	Drug: HB002.1TParticipants received a 2mg/kg dose of HB002.1T via intravenous injection.
HB002.1T 4mg/kg	Experimental	Drug: HB002.1TParticipants received a 4mg/kg dose of HB002.1T via intravenous injection.
HB002.1T 8mg/kg	Experimental	Drug: HB002.1TParticipants received a 8mg/kg dose of HB002.1T via intravenous injection.
HB002.1T 12mg/kg	Experimental	Drug: HB002.1TParticipants received a 12mg/kg dose of HB002.1T via intravenous injection.
HB002.1T 16mg/kg	Experimental	Drug: HB002.1TParticipants received a 16mg/kg dose of HB002.1T via intravenous injection.
HB002.1T 20mg/kg	Experimental	Drug: HB002.1TParticipants received a 20mg/kg dose of HB002.1T via intravenous injection.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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

Key exclusion criteria (23 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HB002.1THB002.1T is a Vascular Endothelial Growth Factor Receptor Decoy	Drug	HB002.1T 12mg/kg, HB002.1T 16mg/kg, HB002.1T 20mg/kg, HB002.1T 2mg/kg, HB002.1T 4mg/kg, HB002.1T 8mg/kg

Primary outcome

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

6 secondary outcomes

Titer and detection rate of anti drug antibody
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HB002.1T in people with Solid Tumor, run by Huabo Biopharm Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03636750.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.