A Study of NKT2152, a HIF2a Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma

Active:	Yes
Cancer Type:	Kidney Cancer Unknown Primary	NCT ID:	NCT05119335
Trial Phases:	Phase I Phase II	Protocol IDs:	NKT2152-101 (primary) NCI-2021-13434
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	NiKang Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05119335

Summary

The goal of the Phase 1 portion is to identify the maximum tolerated dose (MTD) and/or the
recommended doses for expansion (RDEs) of NKT2152. The Phase 2 portion will evaluate the
efficacy of NKT2152 in ccRCC.

Objectives

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.

Phase 1 is designed to determine the MTD and/or RDEs 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. Patients will be randomized to one of two dosage
levels selected for further evaluation.

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