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

NCT07087158 | Not Yet Recruiting Phase 2

• 1 other identifier: IBR854-203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma (RCC)

Keywords

IBR854

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  The time from randomization to the first radiologically confirmed disease progression or death from any cause (whichever occurs first).

  Approximately 2 years

Secondary Outcomes (5)

• Overall Survival (OS)

  Approximately 4 years

• Objective Response Rate (ORR)

  Approximately 2 years

• Disease Control Rate (DCR)

  Approximately 2 years

• Duration of Response (DoR)

  Approximately 2 years

• Adverse Events (AEs)

  Approximately 2 years

Study Arms (2)

Experimental arm

EXPERIMENTAL

IBR854 + Pazopanib

Drug: IBR854; Drug: Pazopanib

Control arm

ACTIVE COMPARATOR

Pazopanib

Drug: Pazopanib

Interventions

IBR854 DRUG

Every 21 days is one cycle, and IBR854 will be dosed in a route of intravenous infusion on day 1 and day 8 of each cycle with a fixed dose of 9.0×10\^9 cells.

Experimental arm

Pazopanib DRUG

Pazopanib will be dosed orally once daily without food (at least 1 hour before or 2 hours after a meal) with a fixed dose of 800mg.

Control arm; Experimental arm

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 old
• Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.
• Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.
• Expected survival period is at least 3 months.
• ECOG performance status of 0 or 1, or KPS score of at least 70.
• Has measurable disease per RECIST 1.1.
• Organ function should meet the following criteria:
• 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).
• 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).
• Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 1.5× ULN) \> 50 ml/min (Cockcroft-Gault formula).
• Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.
• Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures.

You may not qualify if:

• Documented central nervous system metastases.
• Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.
• 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.
• 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.
• 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.
• 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:
• Topical, intranasal, or inhaled corticosteroids.
• Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging).
• Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency.
• Low-dose corticosteroids for orthostatic hypotension.
• Clinically significant cardiovascular or cerebrovascular disease documented by any of the following:
• Ischemic stroke (excluding silent lacunar infarction) or severe thromboembolic event within 6 months before the first dose of study treatment.
• Myocardial infarction, unstable angina, congestive heart failure, or clinically significant arrhythmia within 6 months before the first dose of study treatment.
• New York Heart Association (NYHA) class ≥ II heart failure before the first dose of study treatment.
• QTcF interval \>450 ms (men) or \>470 ms (women) before the first dose of study treatment.

Sponsors & Collaborators

• Imbioray (Hangzhou) Biomedicine Co., Ltd.: lead

Study Sites (1)

The Cancer Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Dingwei Ye, PhD

CONTACT

+86-13701663571; dwyeli@163.com

Study Design

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

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)