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Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05119335
Study type Interventional
Source NiKang Therapeutics, Inc.
Contact Heather Askew, BSc
Phone 302-415-5127
Email [email protected]
Status Recruiting
Phase Phase 1/Phase 2
Start date October 26, 2021
Completion date September 2026

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