IB-T101 injection for advanced clear cell kidney cancer
Official title: 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
Run by Grit Biotechnology · NCT06819293 · Data updated 2026-11-12
This study is testing a new injection called IB-T101 to see if it can help adults with advanced clear cell kidney cancer feel better and respond well to treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | December 6, 2024 |
| Main results expected | December 7, 2027 |
| Study ends | December 7, 2027 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT06819293 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with advanced clear renal cell carcinoma and an ECOG performance status of 0 or 1.
✕Probably not a fit
Patients with significant CNS dysfunction, severe immunodeficiency, recent myocardial infarction, or those requiring drainage for pleural effusion may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, single-center, dose escalation and extension study evaluates the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma. Participants will receive the IB-T101 injection, and the study aims to determine the appropriate dosing and monitor patient responses. The trial is designed for patients who meet specific eligibility criteria, including performance status and expected survival time.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced clear cell renal cell carcinoma.
How similar studies have gone: While this approach is novel, similar studies targeting advanced renal cell carcinoma have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Tongji hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Bo Liu
- Email: liubo0124@163.com
- Phone: 15927168582
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.