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

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

Recruiting
18 years and older
All
Phase 1

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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

Eligibility

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

Study details
    Advanced Clear Renal Cell Carcinoma
    Adult

NCT06819293

Grit Biotechnology

30 March 2025

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