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A Study of HB0025 Injection in Patients With Advanced Renal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Study of HB0025 Injection in Patients With Advanced Renal Cancer

A Phase II, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of HB0025 in Patients With Advanced Renal Cancer

NCT06222125•Huabo Biopharm Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+4 more criteria

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.
+21 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 30, 2023

Primary Completion Date

January 30, 2025

Completion Date

December 30, 2025

Last Updated

January 24, 2024

Enrollment

100

ESTIMATED participants

Conditions

Renal Cancer

Interventions

HB0025

DRUG

Contacts

Junning Wang, Master

CONTACT

021-51320053 junning.wang@huaota.com

Juan Chen, MD

CONTACT

021-51320053 juan.chen@huaota.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of HB0025 Injection in Patients With Advanced Renal Cancer

Inclusion Criteria

Exclusion Criteria

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