Trial Title:
A Study of HB0025 Injection in Patients With Advanced Renal Cancer
NCT ID:
NCT06222125
Condition:
Renal Cancer
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Sequential Assignment This study will enroll 20 subjects at 10mg/kg and 20mg/kg
respectively every 2 weeks (Q2W)to compare the safety and efficacy, and will be extended
to the group with better efficacy and tolerance.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HB0025
Description:
HB0025 IV every 2 weeks (q2w)
Arm group label:
Arm 1
Arm group label:
Arm 2
Other name:
Recombinant humanized anti-programmed cell death-ligand 1（Anti-PD-L1） monoclonal antibody-VEGFR1 fusion protein
Summary:
It is a phase II open label, multicenter study to assess the safety, tolerability,
pharmacokinetics, and efficacy of HB0025 in patients with advanced clear cell renal cell
carcinoma (ccRCC).
Detailed description:
The phase II study will enroll subjects with advanced clear cell renal cell carcinoma
(ccRCC) who have progressing tumor after standard therapy and have no better treatment
option.This study will set up 2 dose groups.HB0025 injection is administered once every 2
weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female. Age ≥ 18 years.
- The subject is able to understand and willing to sign the informed consent form
(ICF) ; willing and able to comply with all study procedures.
- Patients with histologically and/or cytologically confirmed advanced clear cell
renal cell carcinoma (defined as more than 50% clear cell component) that is not
suitable for radical treatment or recurrence / metastasis, with or without
sarcomatoid features; may benefit from investigational drug therapy as judged by the
investigator; and who have disease progression after receiving at least one previous
systemic treatment regimen (tyrosine kinase drugs such as sunitinib, axitinib,
pazopanib, sorafenib, etc., other drugs such as everolimus, excluding treatment with
immune checkpoint inhibitors) or who cannot tolerate the current standard treatment
as judged by the investigator.
- At least one measurable tumor lesion was present according to RECIST 1.1. At the
same scan level of CT or MRI scan, the longest diameter of non-lymph node lesions is
at least 10 mm, and the short diameter of lymph node lesions is ≥ 15 mm. A baseline
imaging assessment could be performed up to 28 days before the first dose.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Life expectancy ≥3 mouths
- liver function requirements:
1. Total bilirubin (TBIL) ≤ 1.5×ULN
2. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5×ULN;
AST or ALT ≤5×ULN if liver metastases are present.
- Creatinine (Scr) < 1.5×ULN and Calculated creatinine clearance (CrCL) > 40 mL/ min
(Cockcroft-Gault Equation).
- Hematology：
1. absolute neutrophil count (ANC) ≥ 1,500/µL. (No use of recombinant human
granulocyte colony-stimulating factor to support treatment within 14 days
before the first administration of HB0025).
2. hemoglobin (HGB) ≥ 9 g/dL. (No transfusion or hemoglobin support within 14 days
of HB0025 first administration).
3. platelets (PLT) ≥ 75,000/µL. (No transfusion or recombinant human
thrombopoietin support within 14 days of HB0025 first administration).
Exclusion Criteria:
- Have clinically active central nervous system (CNS) metastases. Patients with
asymptomatic brain metastases who have been in a stable condition of imaging and
neurological evaluation for more than 4 weeks after receiving relevant treatment
will be allowed. Patients who have undergone hormone therapy can be enrolled only if
the hormone therapy dose is less than 10 mg/day prednisone or the equivalent dose of
other hormones for at least 2 weeks.
- 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, intraarticular, intranasal, or inhaled corticosteroids and systemic
steroids to prevent (e.g., allergy to contrast agents) or treat non-autoimmune
condition (e.g., delayed hypersensitivity caused by exposure to allergens) will be
allowed.
- Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial
infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or
IV heart failure < 6 months of study entry; uncontrolled arrhythmia < 3 months of
study entry; mean ECG QT-interval corrected according to Fridericia's formula (QTcF)
> 470 milliseconds (ms) (male) or QTcF > 480 ms (female) obtained from three ECGs.
- Uncontrolled diabetes, glycosylated hemoglobin HbA1c >8%；
- Those who have previously received PD-1 pathway inhibitors or cytotoxic T lymphocyte
associated antigen-4 (CTLA-4) antibodies or macromolecular vascular endothelial
growth factor (VEGF) inhibitors (such as bevacizumab, ramucirumab, etc.).
- Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter)
prior to study entry; palliative radiotherapy to a single area < 2 weeks prior to
study screening is permitted. Measurable lesions cannot be previously irradiated
unless they have demonstrated growth after radiation therapy (According to RECIST
v1.1).
- Patients who have previously received allogeneic stem cell, Bone marrow or solid
organ transplantation.
- Concurrent malignancy < 5 years prior to entry other than adequately treated
cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell
carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or <
T1 urothelial carcinoma.
- Any of the following infections:
1. Active infection unresolved less than 2 weeks prior to first dose of study
drug.
2. Active Pulmonary tuberculosis.
3. Positive results for HIV test.
4. Active hepatitis B or C. Patients with asymptomatic hepatitis B virus carriers
(HBV DNA titer < 1000 cps/mL or 200 IU/mL) or cured hepatitis C (negative
hepatitis C virus RNA test) can be enrolled.
- Major surgery < 4 weeks prior to the first dose; Minor surgery < 2 weeks prior to
the first dose.
- History of severe allergic reactions, grade 3-4 allergic reactions to treatment with
another monoclonal antibody or known to be allergic to protein drugs or recombinant
proteins or excipients in HB0025 drug formulation.
- Have received or will receive a live vaccine within 30 days prior to the screening.
- Pregnant or breastfeeding women.
- Patients who have participated in any clinical trial of a drug or medical device
within 30 days prior to the first dose or participate in other drug clinical trials,
the elution period of the test drug has not reached 5 half-lives.
- Any other serious underlying medical condition (e.g., active gastric ulcer,
uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe
signs and symptoms of coagulation and clotting disorders, cardiac conditions), or
psychiatric, psychological, familial condition or geographical location that, in the
judgment of the Investigator, may interfere with the planned staging, treatment and
follow-up, affect patient compliance or place the patient at high risk from
treatment.
- Fertile subjects who do not want to use effective contraception during HB0025
treatment and within 90 days after the last dose.
- Positive COVID-19 quantitative real time (qRT) polymerase chain reaction (PCR) or
rapid screening test during screening, except for patients who turned negative 1
week before administration without comorbidities and required more than 2 negative
tests at intervals of not less than 72 hours.
- Patients with a history of arterial or deep vein thrombosis within 6 months before
enrollment; evidence or history of a bleeding tendency within 2 months before
enrollment.
- Severe dyspnea, pulmonary insufficiency or the need for continuous supportive oxygen
therapy.
- Unhealed wound or ulcer; fractures from any cause within 3 months before screening
- Conditions that may cause bleeding or perforation of the digestive tract (such as
duodenal ulcer, intestinal obstruction, Crohn's disease, Ulcerative colitis, large
gastrectomy and small bowel resection, etc.); Patients with a history of intestinal
perforation and fistula, who were not cured after surgical treatment; Esophageal and
gastric varices.
- Immunomodulators, including but not limited to cyclosporine and tacrolimus, were
administered within 2 weeks before enrollment.
- Other conditions which would make it inappropriate for the patient to participate as
judged by the investigator.
- Arterial hypertension (systolic blood pressure > 140 mmHg or diastolic blood
pressure ≥ 100 mmHg) that could not be controlled even with standard treatment.
- Patients with urine protein ≥ 2 + using test strips should have 24-hour urine
collection, and patients with 24-hour urine protein content ≥ 2g.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingwei Ye, MD/PHD
Phone:
021-64175590
Email:
fuscc2012@163.com
Start date:
January 30, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Huabo Biopharm Co., Ltd.
Agency class:
Industry
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/NCT06222125
