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Renal Cell Carcinoma (RCC)Phase 2NCT07087158

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

A Phase 2 study testing IBR854 and Pazopanib in people with Renal Cell Carcinoma (RCC), run by Imbioray (Hangzhou) Biomedicine Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma (RCC)
What is being tested?
IBR854 and Pazopanib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
8 Sep 2025to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
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  • 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.
  • Left-ventricular ejection fraction (LVEF) ≤50 % before the first dose of study treatment.
  • Prior organ transplant, except corneal transplant; prior allogeneic stem-cell transplant.
  • Hepatitis B surface antigen (HBsAg) positive with HBV DNA >500 IU/mL or >2,500 copies/mL, or hepatitis C antibody positive with detectable HCV RNA, or known HIV infection, or active tuberculosis.
  • Interstitial lung disease or non-infectious pneumonitis that is currently symptomatic or has previously required systemic corticosteroids, in the opinion of the investigator likely to interfere with toxicity assessment or management.
  • Any severe, progressive, or uncontrolled medical condition that, in the investigator's judgment, makes the subject unsuitable for the study, including but not limited to:
  • Infection requiring systemic therapy.
  • Symptomatic pleural, pericardial, or ascitic fluid requiring or having undergone drainage within 2 weeks before the first dose (minimal asymptomatic effusion, third-spacing due to hypoalbuminaemia, or cases where benefit outweighs risk may be allowed).
  • History of coagulopathy (e.g., deep-vein thrombosis) or severe bleeding diathesis; clinically significant bleeding event (e.g., gastrointestinal bleeding) within 1 month before the first dose.
  • History of severe psychiatric disorder.
  • Any other condition that, in the investigator's opinion, renders study participation riskier than beneficial.
  • Prior grade 3-4 immune-related adverse events that, in the investigator's judgment, should be excluded.
  • Severe allergic or hypersensitivity disorders, significant drug allergies (including to investigational agents), or known hypersensitivity to any component of the study drug, including severe reactions to monoclonal antibodies.
  • Participation in another clinical trial and receipt of an investigational agent within 28 days before the first dose of study treatment.
  • Clinically significant organ dysfunction or comorbidity likely to interfere with protocol adherence.
  • Live vaccine received within 30 days before the first dose, or planned during the study or within 1 month after the last dose.
  • Pregnant or breast-feeding women (women who agree to discontinue breast-feeding before signing informed consent may be enrolled).
  • Any other condition or circumstance that, in the investigator's opinion, unsuitable for participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dingwei Ye, PhD contact

+86-13701663571

dwyeli@163.com

China1 site, 1 recruiting

  • The Cancer Hospital of Fudan University

    Shanghai

    Ning Ye, PhD, +86-13701663571, dwyeli@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the 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.
Being tested
IBR854, Pazopanib
Keywords
IBR854
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBR854Drug

    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.

  • PazopanibDrug

    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.

Study groups in NCT07087158
Study groupRoleWhat they receive
Experimental armExperimentalIBR854 + Pazopanib
Receives: Drug: IBR854; Drug: Pazopanib
Control armActive comparatorPazopanib
Receives: Drug: Pazopanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

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

    Measured: Approximately 2 years

Secondary outcomes (5)

  1. Overall Survival (OS)

    The time from randomization to death from any cause (whichever occurs first).

    Measured: Approximately 4 years

  2. Objective Response Rate (ORR)

    Proportion of participants who have a CR or PR per RECIST 1.1.

    Measured: Approximately 2 years

  3. Disease Control Rate (DCR)

    Proportion of participants who have a CR, PR or SD per RECIST 1.1.

    Measured: Approximately 2 years

  4. Duration of Response (DoR)

    The time from the date of first response until date of the first radiologically confirmed disease progression per RECIST 1.1.

    Measured: Approximately 2 years

  5. Adverse Events (AEs)

    The incidence and severity of adverse events.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start8 Sep 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07087158
Sponsor's protocol ID
IBR854-203
Status last verified
Nov 2026
First submitted
18 Jul 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IBR854 and Pazopanib in people with Renal Cell Carcinoma (RCC), run by Imbioray (Hangzhou) Biomedicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dingwei Ye, PhD (+86-13701663571, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07087158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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