Trial Title:
A Study of HB0030 Injection in Patients With Advanced Solid Tumors
NCT ID:
NCT05706207
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
0.03 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 1
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
0.3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 2
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
1 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 3
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
3 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 4
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
10 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 5
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
20 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 6
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
30 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 7
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
Intervention type:
Drug
Intervention name:
HB0030 injection
Description:
40 mg/kg intravenously, every 3 weeks, till tumor progress or intolerance
Arm group label:
Arm 8
Other name:
Recombinant Humanized Anti-TIGIT Monoclonal Antibody
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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）
1. Adequate Hematological function defined as:
1. Absolute neutrophil count ≥1.5×109/L
2. Platelet count≥75×109/L
3. Hemoglobin ≥ ≥90g/L
2. Adequate hepatic function defined as:
1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
2. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 ×
ULN; AST or ALT ≤ 5 × ULN if subjects have liver metastases or liver
cancer
3. Adequate renal function defined as:
creatinine clearance (CrCL) > 50 mL/min (calculated by Cockcroft-Gault
Equation).
4. Adequate Coagulation function defined as:
1. Activated partial thromboplastin time (APTT) ≤1.5×ULN
2. International Normalized Ratio (INR)≤1.5×ULN
5. 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.
Exclusion Criteria:
- 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:
1. 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
2. Serious cardiac rhythm or conduction abnormality, such as ventricular
arrhythmia requiring clinical intervention, II-III degree atrioventricular
block, QTcF≥450 ms, etc
3. New York Heart Association（NYHA）cardiac function grade ≥ Grade II or left
ventricular ejection fraction(LVEF)<50%
4. 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：
1. Nitrosourea or mitomycin C within 6 weeks before the first use of the study
drug
2. 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)
3. 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：
1. Active infection within 2 weeks before screening, requiring intravenous
medication
2. Active tuberculosis (via medical history).
3. Positive test for HIV antibody at screening.
4. 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Zip:
233004
Country:
China
Status:
Recruiting
Contact:
Last name:
huan zhou, master
Phone:
+8613665527160
Email:
zhouhuanbest@vip.163.com
Start date:
December 21, 2021
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Huabo Biopharm Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
First Affiliated Hospital Bengbu Medical College
Agency class:
Other
Source:
Huabo Biopharm Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05706207
