Advanced Solid TumorPhase 1NCT05706207
A Study of HB0030 Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing HB0030 injection in people with Advanced Solid Tumor, run by Huabo Biopharm Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ia single-center, open-label, dose escalation study.The objectives of this study are to evaluate the safety, toxicity, tolerability, pharmacokinetics/pharmacodynamics(PK/PD), immunogenicity, biomarkers, and antitumor activity of HB0030 in advanced solid tumor subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HB0030 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2021to 30 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female Age ≥ 18 years.
- Patients with histologically or cytologically confirmed advanced malignant solid tumor who have been intolerant of all standard therapies or recurrence after all standard therapies, and there is no better treatment option.
- At least one measurable tumor lesion According to RECIST criteria v1.1
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- Life expectancy ≥3 months
- Adequate organ function defined as:（No blood transfusion or hematopoietic stimulator treatment within 14 days before screening）
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- Adequate Hematological function defined as:
- Absolute neutrophil count ≥1.5×109/L
- Platelet count≥75×109/L
- Hemoglobin ≥ ≥90g/L
- Adequate hepatic function defined as:
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; AST or ALT ≤ 5 × ULN if subjects have liver metastases or liver cancer
- Adequate renal function defined as:
- creatinine clearance (CrCL) > 50 mL/min (calculated by Cockcroft-Gault Equation).
- Adequate Coagulation function defined as:
- Activated partial thromboplastin time (APTT) ≤1.5×ULN
- International Normalized Ratio (INR)≤1.5×ULN
- Urine protein: qualitative urine protein ≤ 1+ or qualitative urine protein≥ 2+,24h urine protein<1g
- The fertile subjects (male and female) must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners during the test period and at least 90 days after the last medication; The blood or urine pregnancy test of female patients of childbearing age within 7 days before the first administration must be negative
- Subjects can fully understand this study and voluntarily sign the informed consent form before the trial, and are willing and able to follow the clinical research and follow-up visit process.
Who cannot join
- Symptomatic central nervous system(CNS) metastases; or there is other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for enrollment according to the judgment of the investigator; or patients with asymptomatic CNS metastases who are radiologically and neurologically stable > 4 weeks following CNS directed therapy, and are on a stable or decreasing dose of corticosteroids equivalent to < 10 mg prednisone/day for at least 2 weeks prior to study treatment are eligible for study entry.
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
- History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for grade 3 endocrinopathy that is managed with hormone replacement therapy).
- Use of systemic corticosteroids in a dose equivalent to > 10 mg/day of prednisone or other immunosuppressive agent < 2 weeks prior to screening; the use of topical, intraocular, intra-articular, intranasal or inhaled corticosteroids (systemic absorption is low) will be allowed to prevent (e.g. allergy to contrast agents) or treat non-autoimmune condition (e.g. delayed hypersensitivity caused by exposure to allergens)
- Patients who Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular and cerebrovascular events of grade 3 or above occurred within 6 months before enrollment
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- Serious cardiac rhythm or conduction abnormality, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, QTcF≥450 ms, etc
- New York Heart Association（NYHA）cardiac function grade ≥ Grade II or left ventricular ejection fraction(LVEF)<50%
- Uncontrolled arterial hypertension even after standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg)
- Uncontrolled diabetes mellitus with hemoglobin A1c > 8%.
- Patients who Have received TIGIT inhibitor treatment in the past
- Patients who Have received chemotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 4 weeks before enrollment， Except for the following：
- Nitrosourea or mitomycin C within 6 weeks before the first use of the study drug
- Oral fluorouracil and small molecule targeted drugs are taken 2 weeks before the first use of the study drug or within 5 half-life of the drug(according to whichever is longer)
- The Chinese medicine with anti-tumor indication is within 2 weeks before the first use of the study drug
- Patients who Have received stem cell, bone marrow or solid organ transplantation in the past
- Any of the following infections：
- Active infection within 2 weeks before screening, requiring intravenous medication
- Active tuberculosis (via medical history).
- Positive test for HIV antibody at screening.
- Active hepatitis B or C. HBV carriers without active disease (HBV DNA titer < 1000 cps/mL or 200 IU/mL), or cured Hepatitis C (negative hepatitis C virus RNA test) may be enrolled.
- patients who have received major surgical treatment (excluding diagnostic puncture, venous catheterization, etc.), interventional treatment, radiotherapy and ablation treatment within 4 weeks before screening
- patients who have a history of severe allergy, has experienced 3-4 grade allergic reaction when receiving other monoclonal antibodies, or is known to be allergic to protein drugs or recombinant proteins or HB0030 drug components
- Patients who have received live virus vaccine within 30 days before screening except for Corona Virus Disease 2019(COVID-19) vaccine
- Pregnant or breast-feeding females
- Patient who has participated in other clinical studies and received study drugs within 30 days before the first dose Administration of study.
- Any other serious diseases (e.g. active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe symptoms and signs of blood coagulation disorder, heart disease).or in the judgment of the Investigator, there are some situation may interfere with the planned staging, treatment and follow-up. Or The patient's compliance is affected or the subject is at high risk of treatment complications.
- COVID-19 infected persons with positive quantitative real time(qRT) polymerase chain reaction(PCR )and/or serological test results during screening.
- Severe dyspnea or pulmonary dysfunction or need for continuous supportive oxygen inhalation.
- The skin wound, surgical site, wound site, mucosa serious ulcer or fracture did not fully heal, and the investigator judged that it was not suitable for enrollment.
- Patients with gastrointestinal bleeding within 12 weeks before the administration of the first study drug or with active gastrointestinal bleeding judged by the investigator.
- Patients with a history of interstitial lung disease or non-infectious pneumonia, except those caused by radiotherapy (enrollment shall be determined after discussion with the medical supervisor)
- Inability to comply with study and follow-up procedures
- Patients unable to comply with study procedures
- Patients who in the judgement of the Investigator are not suited to participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
huan zhou, master, +8613665527160, zhouhuanbest@vip.163.com
About this study
Official title: A Phase Ia,Single Center,Open-label,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of HB0030 Injection in Patients With Advanced Solid Tumors
This is a phase Ia single-center, open-label, dose escalation study.The objectives of this study are to evaluate the safety, toxicity, tolerability, pharmacokinetics/pharmacodynamics(PK/PD), immunogenicity, biomarkers, and antitumor activity of HB0030 in advanced solid tumor subjects.
Read the detailed description
The phase Ia study will enroll up to 19-36 subjects with advanced solid tumor who have progressing tumor after standard therapy and have no better treatment option.The conventional 3+3 design will be applied for dose escalation.This study will set up 8 dose groups.HB0030 injection is administered once every 3 weeks.
- Conditions
- Advanced Solid Tumor
- Being tested
- HB0030 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
0.03 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
0.3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
1 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
10 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
20 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
30 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
HB0030 injectionDrug
Also called Recombinant Humanized Anti-TIGIT Monoclonal Antibody
40 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Treatment with 0.03 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 2 | Experimental | Treatment with 0.3 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 3 | Experimental | Treatment with 1 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 4 | Experimental | Treatment with 3 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 5 | Experimental | Treatment with 10 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 6 | Experimental | Treatment with 20 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 7 | Experimental | Treatment with 30 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
| Arm 8 | Experimental | Treatment with 40 mg/kg HB0030 injection administered intravenously Receives: Drug: HB0030 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity(DLT)
- DLT refers to the following toxicity related to HB0030 occurred during the DLT evaluation period (the first treatment cycle):
- Hematological Dose Limiting toxicity include：
- Grade 4 anaemia
- Grade IV neutropenia confirmed by reexamination.
- Grade 3 or higher febrile neutropenia
- Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding
- Nonhematologic Dose Limiting toxicity include：
- Grade IV Nonhematologic Toxicity
- Grade 3 non-hematological toxicity, which cannot be recovered to ≤ Grade 2 within 3 days after the best treatment
- Failure to control grade III hypertension (uncontrolled <160/100 mmHg in 7 days with appropriate antihypertensive therapy)
- Other toxicities judged by investigators to require permanent discontinuation of HB0030
- the above toxic reaction is evaluated by laboratory ,physical ,ECG, radiographic examination and etc.
- Adverse events will be graded by NCI CTCAE v5.0
Measured: Up to 21 days
Maximum Tolerated Dose(MTD)
- Maximum Tolerated Dose is defined as the highest dose in which the number of cases of DLT is less than 1/3 of the total patients in the first treatment cycle (DLT evaluation period) of the dose increasing stage.Six subjects are required to confirm MTD
Measured: Up to 24 Months
Secondary outcomes (8)
Maximum serum concentration(Cmax)
- Cmax refers to The maximum blood concentration of HB0030 after administration.
- Sample concentration analysis method adopts ELISA .
- parameters will be calculated by Phoenix WinNonlin version 8.3 using noncompartmental analysis
Measured: within 48 hours after single HB0030 administered
half-life (t1/2)
- t1/2 refers to time of a half reduction of total drug concentration in Body.
- parameters will be calculated by Phoenix WinNonlin version 8.3 using noncompartmental analysis
Measured: within 3 months after first dose of HB0030 administered
time of maximum concentration(Tmax)
- peak time after HB0030 administration.parameters will be calculated by Phoenix WinNonlin version 8.3 using noncompartmental analysis
Measured: within 48 hours after single HB0030 administered
AUClast
- AUClast refers to Area under the curve (AUC) from the time of 0 to the last measurable concentration.
- parameters will be calculated by Phoenix WinNonlin version 8.3 using noncompartmental analysis.
Measured: Up to 24 Months
Objective response rate (ORR)
ORR defined as the number of patients were confirmed complete response(CR) and/or partial response(PR) according to RECIST 1.1 divided by the patients with at least one tumour evaluation
Measured: Up to 24 Months
Disease control rate (DCR)
DCR defined as the number of patients were confirmed CR and/or PR and/or stable disease(SD) according to RECIST 1.1 divided by the patients with at least one tumour evaluation
Measured: Up to 24 Months
Duration of response (DOR)
DOR defined as time from the first record of CR or PR to the first record of disease progression or death of subjects
Measured: Up to 24 Months
Anti-drug antibody (ADA)
Using the ELISA method to detect the anti-drug antibody production in peripheral blood after HB0030 administration.
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start21 Dec 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Sequential
- Model description
- Subjects were enrolled from low to high doses. The dose groups were 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg and 40 mg/kg, a total of 8 dose levels.For the first dose group (0.03mg/kg), the dose was increased according to the principle of accelerated titration combined with 3+3 dose acceleration.from 0.3mg/kg dose group,the study will adopt the 3+3 dose acceleration principle.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Sponsor
- Investigators
- huan zhou, master, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706207
- Sponsor's protocol ID
- HB0030-01
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia,Single Center,Open-label,Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of HB0030 Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05706207
- Acronym / sponsor ID
- HB0030-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 31 Jan 2023 (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.
This is a phase Ia single-center, open-label, dose escalation study.The objectives of this study are to evaluate the safety, toxicity, tolerability, pharmacokinetics/pharmacodynamics(PK/PD), immunogenicity, biomarkers, and antitumor activity of HB0030 in advanced solid tumor subjects.
Detailed description
The phase Ia study will enroll up to 19-36 subjects with advanced solid tumor who have progressing tumor after standard therapy and have no better treatment option.The conventional 3+3 design will be applied for dose escalation.This study will set up 8 dose groups.HB0030 injection is administered once every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- Subjects were enrolled from low to high doses. The dose groups were 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg and 40 mg/kg, a total of 8 dose levels.For the first dose group (0.03mg/kg), the dose was increased according to the principle of accelerated titration combined with 3+3 dose acceleration.from 0.3mg/kg dose group,the study will adopt the 3+3 dose acceleration principle.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: HB0030 injectionTreatment with 0.03 mg/kg HB0030 injection administered intravenously |
| Arm 2 | Experimental | Drug: HB0030 injectionTreatment with 0.3 mg/kg HB0030 injection administered intravenously |
| Arm 3 | Experimental | Drug: HB0030 injectionTreatment with 1 mg/kg HB0030 injection administered intravenously |
| Arm 4 | Experimental | Drug: HB0030 injectionTreatment with 3 mg/kg HB0030 injection administered intravenously |
| Arm 5 | Experimental | Drug: HB0030 injectionTreatment with 10 mg/kg HB0030 injection administered intravenously |
| Arm 6 | Experimental | Drug: HB0030 injectionTreatment with 20 mg/kg HB0030 injection administered intravenously |
| Arm 7 | Experimental | Drug: HB0030 injectionTreatment with 30 mg/kg HB0030 injection administered intravenously |
| Arm 8 | Experimental | Drug: HB0030 injectionTreatment with 40 mg/kg HB0030 injection administered intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female Age ≥ 18 years.
- Patients with histologically or cytologically confirmed advanced malignant solid tumor who have been intolerant of all standard therapies or recurrence after all standard therapies, and there is no better treatment option.
- At least one measurable tumor lesion According to RECIST criteria v1.1
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
- Life expectancy ≥3 months
Key exclusion criteria (35 listed)
- Symptomatic central nervous system(CNS) metastases; or there is other evidence that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for enrollment according to the judgment of the investigator; or patients with asymptomatic CNS metastases who are radiologically and neurologically stable > 4 weeks following CNS directed therapy, and are on a stable or decreasing dose of corticosteroids equivalent to < 10 mg prednisone/day for at least 2 weeks prior to study treatment are eligible for study entry.
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
- History of Grade 3-4 immune-related adverse events (irAEs) or irAEs requiring discontinuation of prior therapies, (except for grade 3 endocrinopathy that is managed with hormone replacement therapy).
- Use of systemic corticosteroids in a dose equivalent to > 10 mg/day of prednisone or other immunosuppressive agent < 2 weeks prior to screening; the use of topical, intraocular, intra-articular, intranasal or inhaled corticosteroids (systemic absorption is low) will be allowed to prevent (e.g. allergy to contrast agents) or treat non-autoimmune condition (e.g. delayed hypersensitivity caused by exposure to allergens)
- Patients who Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
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 |
|---|---|---|
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody0.03 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 1 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody0.3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 2 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody1 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 3 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 4 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody10 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 5 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody20 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 6 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody30 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 7 |
| HB0030 injectionAlso: Recombinant Humanized Anti-TIGIT Monoclonal Antibody40 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance | Drug | Arm 8 |
Primary outcome
Dose Limiting Toxicity(DLT)
Time frame: Up to 21 days
* DLT refers to the following toxicity related to HB0030 occurred during the DLT evaluation period (the first treatment cycle): 1. Hematological Dose Limiting toxicity include： 1. Grade 4 anaemia 2. Grade IV neutropenia confirmed by reexamination. 3. Grade 3 or higher febrile neutropenia 4. Grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding 2. Nonhematologic Dose Limiting toxicity include： 1. Grade IV Nonhematologic Toxicity 2. Grade 3 non-hematological toxicity, which cannot be recovered to ≤ Grade 2 within 3 days after the best treatment 3. Failure to control grade III hypertension (uncontrolled <160/100 mmHg in 7 days with appropriate antihypertensive therapy) 4. Other toxicities judged by investigators to require permanent discontinuation of HB0030 * the above toxic reaction is evaluated by laboratory ,physical ,ECG, radiographic examination and etc. * Adverse events will be graded by NCI CTCAE v5.0
Maximum Tolerated Dose(MTD)
Time frame: Up to 24 Months
- Maximum Tolerated Dose is defined as the highest dose in which the number of cases of DLT is less than 1/3 of the total patients in the first treatment cycle (DLT evaluation period) of the dose increasing stage.Six subjects are required to confirm MTD
8 secondary outcomes
Maximum serum concentration(Cmax)
Time frame: within 48 hours after single HB0030 administered
half-life (t1/2)
Time frame: within 3 months after first dose of HB0030 administered
time of maximum concentration(Tmax)
Time frame: within 48 hours after single HB0030 administered
AUClast
Time frame: Up to 24 Months
Objective response rate (ORR)
Time frame: Up to 24 Months
Disease control rate (DCR)
Time frame: Up to 24 Months
Duration of response (DOR)
Time frame: Up to 24 Months
Anti-drug antibody (ADA)
Time frame: Up to 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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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.
huan zhou, master principal investigator
The First Affiliated Hospital of Bengbu Medical University
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 HB0030 injection in people with Advanced 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 35 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact huan zhou, Master (+8613665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity(DLT) (time frame: Up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2023.