RecruitingPhase 2interventionalRules rewrite

Phase 2: testing IBR854 for Renal Cell Carcinoma (RCC)

This is a multicenter, randomly assigned, open-label, active-controlled Phase II clinical study evaluating the how well it works and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.

Official registry: https://clinicaltrials.gov/study/NCT07087158 · Imbioray (Hangzhou) Biomedicine Co., Ltd. · enrollment listed as 30

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are IBR854, or Pazopanib. The registry lists allocation as randomized. This is a multicenter, randomly assigned, open-label, active-controlled Phase II clinical study evaluating the how well it works and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.

They plan to enroll about 30 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: IBR854, Pazopanib

Primary outcome (registry wording): Progression-free Survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to any
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
how well you can do daily activities (ECOG score) 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:

Who the registry excludes

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
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

Public study contact (from the registry)

Dingwei Ye, PhD

+86-13701663571

dwyeli@163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The Cancer Hospital of Fudan University — Shanghai, China (recruiting)

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FAQ about this NCT record

Is NCT07087158 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07087158?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07087158?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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