IB-T101 injection for advanced clear cell kidney cancer
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
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 |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Grit Biotechnology Industry-sponsored |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06819293 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is novel, similar studies targeting advanced renal cell carcinoma have shown promise in the past.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- Tongji hospital, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Bo Liu
- Email: liubo0124@163.com
- Phone: 15927168582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.