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Trial Summary


Protocol No.NKT2152-101
StatusOPEN TO ACCRUAL
Principal InvestigatorLogan, Theodore
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA 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
DescriptionThe 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 EligibilityIn 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 SitesKidney
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu