A Study of HB0025 Injection in Patients With Advanced Renal Cancer

NCT06222125 | Unknown Phase 2

• 1 other identifier: HB0025-0101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 mouths

Secondary Outcomes (11)

• Disease control rate (DCR)

  up to 24 mouths

• Progression-free Survival（PFS）

  up to 24 mouths

• Duration of response (DOR)

  up to 24 mouths

• AUC

  up to 24 mouths

• Cmax

  up to 24 mouths

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: HB0025

Arm 2

EXPERIMENTAL

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

Drug: HB0025

Interventions

HB0025 DRUG

HB0025 IV every 2 weeks (q2w)

Also known as: Recombinant humanized anti-programmed cell death-ligand 1（Anti-PD-L1） monoclonal antibody-VEGFR1 fusion protein

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Huabo Biopharm Co., Ltd.: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Dingwei Ye, MD/PHD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junning Wang, Master

CONTACT

021-51320053; junning.wang@huaota.com

Juan Chen, MD

CONTACT

021-51320053; juan.chen@huaota.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: January 30, 2023
• Primary Completion: January 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)