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A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma

A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma

NCT07087158•Imbioray (Hangzhou) Biomedicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.

Detailed Description

This is a multicenter, randomized, open-label, active-controlled study. Eligible patients with Advanced Renal Cell Carcinoma who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned in a 2:1 ratio to either the experimental arm or the control arm. * Experimental arm: IBR854 in combination with Pazopanib * Control arm: Pazopanib The primary endpoint is PFS per RECIST 1.1. Efficacy and safety datas will be continuously collected until criteria for discontinuation are met.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, age ≥ 18 years old
•2. Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.
•3. Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.
•4. Expected survival period is at least 3 months.
•5. ECOG performance status of 0 or 1, or KPS score of at least 70.
•6. Has measurable disease per RECIST 1.1.
•7. Organ function should meet the following criteria:
•1. Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L; Platelet (PLT) ≥90×10\^9/L; Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
•2. Albumin ≥ 30 g/L; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN).
•3. Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 1.5× ULN) \> 50 ml/min (Cockcroft-Gault formula).
+2 more criteria

Exclusion Criteria

•1. Documented central nervous system metastases.
•2. Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.
•3. Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study.
•4. History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.
•5. Clinically significant gastrointestinal abnormalities such as malabsorption syndrome, major gastric or small-bowel resection that may affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other conditions increasing the risk of perforation; or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the first dose of study treatment.
•6. Systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for:
•1. Topical, intranasal, or inhaled corticosteroids.
•2. Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging).
•3. Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency.
•4. Low-dose corticosteroids for orthostatic hypotension.
+22 more criteria

Locations (1)

The Cancer Hospital of Fudan University

Shanghai, China

Key Dates

Start Date

August 10, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

July 28, 2025

Enrollment

ESTIMATED participants

Conditions

Renal Cell Carcinoma (RCC)

Interventions

IBR854

DRUG

Pazopanib

DRUG

Contacts

Dingwei Ye, PhD

CONTACT

+86-13701663571 dwyeli@163.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: July 28, 2025Data 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 IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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