Actively Recruiting
A Phase I Open Label Study Evaluating the Safety and Efficacy of IB-T101 Injection for Advanced Clear Cell Renal Cell Carcinoma
Led by Grit Biotechnology · Updated on 2026-04-14
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IB-T101 injection in adult patients with advanced clear cell renal cell carcinoma. This open-label, single-center study focuses on assessing the safety, efficacy, and how the body processes IB-T101. The research aims to understand how this biological treatment performs in patients with advanced disease. Participants will receive IB-T101 injection as the experimental treatment. The study includes a dose escalation phase followed by a dose extension phase to explore different dosing levels. The trial is designed to monitor patients over time while they receive the study treatment. During the study, participants will be closely monitored for their response to the treatment and any side effects over a period of three years. Researchers will track the objective response rate and adverse events to evaluate the treatment. Participants' health status will be regularly assessed to ensure safety and effectiveness throughout the trial period.
CONDITIONS
Brief Title
IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily join the study and sign informed consent
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival time of at least 3 months
You will not qualify if you...
- Clinically significant central nervous system dysfunction, such as seizures, cerebral ischemia or hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or autoimmune disease affecting the CNS
- Any form of primary or acquired immunodeficiency, including known HIV positive status
- Myocardial infarction or unstable angina within 6 months prior to screening
- Pleural effusion requiring drainage for symptom management within 28 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive IB-T101 injection to treat advanced clear cell renal cell carcinoma.
Visits scheduled as per treatment protocol
Trial Site Locations
Total: 1 location
1
Tongji hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
B
Bo Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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