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

Huabo Biopharm Co., Ltd.1 site in 1 country100 target enrollmentJanuary 30, 2023

ConditionsRenal Cancer

InterventionsHB0025

DrugsHB0025

Overview

Phase: Phase 2
Intervention: HB0025
Conditions: Renal Cancer
Sponsor: Huabo Biopharm Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 30, 2023

End Date

December 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Huabo Biopharm Co., Ltd.

Responsible Party

Sponsor

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.
•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-
•Life expectancy ≥3 mouths
•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.

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.

Arms & Interventions

Arm 1

10 mg/kg intravenously, every 2 weeks, till tumor progression or intolerance.

Intervention: HB0025

Arm 2

20 mg/kg intravenously, every 2 weeks, till tumor progression or intolerance.

Intervention: HB0025

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Disease control rate (DCR)(up to 24 mouths)
Progression-free Survival（PFS）(up to 24 mouths)
Duration of response (DOR)(up to 24 mouths)
Cmax(up to 24 mouths)
Anti-drug antibody (ADA)(up to 24 mouths)
Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs(up to 24 mouths)
AUC(up to 24 mouths)
Tmax(up to 24 mouths)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(up to 24 mouths)
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs(up to 24 mouths)
Number of Participants With Notable QTc Interval(up to 24 mouths)