Trials / Terminated
TerminatedNCT05119335
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- NiKang Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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. 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oral NKT2152 | Oral HIF2α inhibitor |
Timeline
- Start date
- 2021-10-26
- Primary completion
- 2025-08-22
- Completion
- 2025-09-30
- First posted
- 2021-11-15
- Last updated
- 2025-11-12
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05119335. Inclusion in this directory is not an endorsement.