IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IB-T101 injection.
- Who it may be relevant to
- Registry conditions: Advanced Clear Renal Cell Carcinoma, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I, Open Label, Single Center Study Evaluating the Safety and Efficacy of IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
Overview
This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma
Interventions
- Biological IB-T101 injection
IB-T101 injection to treat advanced clear renal cell carcinoma
Primary outcome measures
- Objective response rate [Time frame: 3 years]
- AEs [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Expected survival time of ≥ 3 months;
Exclusion criteria
- CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.
- Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
- Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
- Pleural effusion requiring drainage for symptom management within 28 days prior to screening
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji hospital, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT06819293 · GTE-002-001