This is a Phase 1/2 open label multicenter study of NKT2152. Phase 1 is a first in human (FIH) dose escalation study in patients aged 18 years or older with clear cell renal carcinoma (ccRCC) who have exhausted available standard therapy as determined by the investigator. Eligible patients will have received <=4 prior lines lines of therapy.~Phase 1 is designed to determine the MTD and/or RP2D of NKT2152 as a single agent administered orally once daily. Depending on the tolerability and PK, additional dosing schedules may be tested.~Phase 2 will evaluate the safety, pharmacokinetics and antitumor efficacy of NKT2152 in ccRCC patients.
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.