Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

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.

Official Title

Phase 1/2 Open Label Dose-escalation and Expansion Trial of NKT2152 an Orally Administered HIF2α Inhibitor to Investigate Safety Pharmacokinetics Pharmacodynamics and Clinical Activity in Patients with Advanced Clear Cell Renal Cell Carcinoma

Details

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.

Keywords

CcRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms, Renal Cancer, Renal Neoplasms, Recurrent Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Refractory Renal Cell Carcinoma, Advanced Renal Cell Carcinoma, Hypoxia, Renal Cell Carcinoma, Hypoxia Inducible Factor (HIF), HIF2α Inhibitor, Hypoxia Inducible Factor 2 Alpha (HIF-2 Alpha), Hypoxia Inducible Factor 2α (HIF-2α), Clear Cell, HIF1α, Renal Cell Carcinoma (RCC), Carcinoma, Neoplasms, Oral NKT2152

Eligibility

Locations

  • UCLA
    Los Angeles California 90095 United States
  • HonorHealth
    Scottsdale Arizona 85258 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NiKang Therapeutics, Inc.
ID
NCT05119335
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 128 study participants
Last Updated