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Trial Summary
| Protocol No. | NKT2152-101 | ||
|---|---|---|---|
| Status | OPEN TO ACCRUAL | ||
| Principal Investigator | Logan, Theodore | ||
| Scope | National | ||
| Phase | Phase I/II | ||
| Age Group | Adult | ||
| Title | A Phase 1/2, open label dose-escalation and expansion trial of NKT2152, an orally administered HIF2αinhibitor, to investigate safety, pharmacokinetics, pharmacodynamics and clinical activity in patients with advanced clear cell renal cell carcinoma | ||
| Description | The goal of the Phase 1 portion is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 Dose (RP2D) of NKT2152. The Phase 2 portion will evaluate the efficacy of NKT2152 in ccRCC. | ||
| Key Eligibility | In order to be eligible to take part in this trial, patients must meet the following criteria: Has locally advanced or metastatic ccRCC and has progressed during treatment, are relapsed, refractory and not amenable to curative therapy or standard therapy (Phase 1); has progressed during treatment with at least 1 prior therapeutic regimen (Phase 2) that contains a PD-1 or PD-L1 compound and/or a VEGF targeting agent, and a total of ≤ 4 prior therapeutic regimens. Must have measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) For a full list of participation criteria, please visit clinicaltrials.gov. | ||
| Applicable Disease Sites | Kidney | ||
| Participating Institutions | Indiana University (IU) | ||
| Treatment Type | Treatment | ||
| Contact | Phone: (317) 278-5632 Email: iutrials@iu.edu | ||