Renal CancerPhase 2NCT06222125
A Study of HB0025 Injection in Patients With Advanced Renal Cancer
A Phase 2 study testing HB0025 in people with Renal Cancer, run by Huabo Biopharm Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- HB0025
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 30 Dec 2025
- Phase
- Phase 2
- 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.
- 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
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- liver function requirements:
- Total bilirubin (TBIL) ≤ 1.5×ULN
- 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：
- 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).
- hemoglobin (HGB) ≥ 9 g/dL. (No transfusion or hemoglobin support within 14 days of HB0025 first administration).
- platelets (PLT) ≥ 75,000/µL. (No transfusion or recombinant human thrombopoietin support within 14 days of HB0025 first administration).
Who cannot join
- 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%；
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- 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:
- Active infection unresolved less than 2 weeks prior to first dose of study drug.
- Active Pulmonary tuberculosis.
- Positive results for HIV test.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Dingwei Ye, MD/PHD, 021-64175590, fuscc2012@163.com
About this study
Official title: A Phase II, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of HB0025 in Patients With Advanced Renal Cancer
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).
Read the 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.
- Conditions
- Renal Cancer
- Being tested
- HB0025
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0025Drug
Also called Recombinant humanized anti-programmed cell death-ligand 1（Anti-PD-L1） monoclonal antibody-VEGFR1 fusion protein
HB0025 IV every 2 weeks (q2w)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 10 mg/kg intravenously, every 2 weeks, till tumor progression or intolerance. Receives: Drug: HB0025 |
| Arm 2 | Experimental | 20 mg/kg intravenously, every 2 weeks, till tumor progression or intolerance. Receives: Drug: HB0025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 mouths
Secondary outcomes (11)
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 mouths
Progression-free Survival（PFS）
progression-free survival (PFS) means the time between the start of treatment and the onset of tumor progression or death from various causes.
Measured: up to 24 mouths
Duration of response (DOR)
DOR defined as time from the first record of CR or PR to the first record of tumor progression or death of subjects
Measured: up to 24 mouths
AUC
Area Under concentration-time Curve (AUC)
Measured: up to 24 mouths
Cmax
Maximum serum concentration (Cmax)
Measured: up to 24 mouths
Tmax
half-life time of maximum concentration
Measured: up to 24 mouths
Anti-drug antibody (ADA)
Using the ELISA method to detect the anti-drug antibody production in peripheral blood after HB0025 administration.
Measured: up to 24 mouths
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Measured: up to 24 mouths
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs
Participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory analysis included hematology, clinical chemistry, thyroid function tests, and urinalysis.
Measured: up to 24 mouths
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Participants with abnormal vital signs (heart rate, blood pressure, temperature, and respiratory rate) and physical examination reported as TEAEs are reported.
Measured: up to 24 mouths
Number of Participants With Notable QTc Interval
Notable QTc intervals included single beat changes from baseline (Day 1) values (> 30, > 60, and > 90 milliseconds). Participants who had notable QTc interval are reported.
Measured: up to 24 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start30 Jan 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huabo Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, MD/PHD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222125
- Sponsor's protocol ID
- HB0025-0101
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of HB0025 in Patients With Advanced Renal Cancer
- ClinicalTrials.gov ID
- NCT06222125
- Acronym / sponsor ID
- HB0025-0101
- Conditions
- Renal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huabo Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: HB002510 mg/kg intravenously, every 2 weeks, till tumor progression or intolerance. |
| Arm 2 | Experimental | Drug: HB002520 mg/kg intravenously, every 2 weeks, till tumor progression or intolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
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 |
|---|---|---|
| HB0025Also: Recombinant humanized anti-programmed cell death-ligand 1（Anti-PD-L1） monoclonal antibody-VEGFR1 fusion proteinHB0025 IV every 2 weeks (q2w) | Drug | Arm 1, Arm 2 |
Primary outcome
Objective response rate (ORR)
Time frame: up to 24 mouths
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.
11 secondary outcomes
Disease control rate (DCR)
Time frame: up to 24 mouths
Progression-free Survival（PFS）
Time frame: up to 24 mouths
Duration of response (DOR)
Time frame: up to 24 mouths
AUC
Time frame: up to 24 mouths
Cmax
Time frame: up to 24 mouths
Tmax
Time frame: up to 24 mouths
Anti-drug antibody (ADA)
Time frame: up to 24 mouths
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: up to 24 mouths
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs
Time frame: up to 24 mouths
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs
Time frame: up to 24 mouths
Number of Participants With Notable QTc Interval
Time frame: up to 24 mouths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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.
Dingwei Ye, MD/PHD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HB0025 in people with Renal Cancer, 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 14 inclusion and 31 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 24 Jan 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Junning Wang, Master (021-51320053 ext. 6029, junning.wang@huaota.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 24 mouths). 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 24 Jan 2024.