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RECRUITINGPHASE1

IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma

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

NCT06819293•Grit Biotechnology

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;
•2. Age ≥18 years old;
•3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
•4. Expected survival time of ≥ 3 months;

Exclusion Criteria

•1. 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.
•2. Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects
•3. Have experienced myocardial infarction or unstable angina within the 6 months prior to screening
•4. Pleural effusion requiring drainage for symptom management within 28 days prior to screening

Locations (1)

Tongji hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

December 6, 2024

Primary Completion Date

December 7, 2027

Completion Date

December 7, 2027

Last Updated

February 17, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Clear Renal Cell CarcinomaAdult

Interventions

IB-T101 injection

BIOLOGICAL

Contacts

Bo Liu

CONTACT

15927168582 liubo0124@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

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