IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrit Biotechnology
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- IB-T101 injection
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov