RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
1. Voluntarily join the study, signed willing to sign a consent form 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;
Who Should NOT Join This Trial:
1. CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune conditions (where your immune system attacks your own body) involving the CNS.
2. Any form of primary and acquired weakened immune system (such as severe combined weakened immune system). Known human weakened immune system 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
IB-T101 injection
IB-T101 injection to treat advanced clear renal cell carcinoma
Locations (1)
Tongji hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China