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:
- 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