A Study of NKT2152, a HIF2α Inhibitor, in Patients with Advanced Clear Cell Renal Cell Carcinoma
- Conditions
- CcRCCClear Cell Renal Cell CarcinomaKidney CancerKidney NeoplasmsRenal CancerRenal NeoplasmsRecurrent Renal Cell CarcinomaMetastatic Renal Cell CarcinomaRefractory Renal Cell CarcinomaAdvanced Renal Cell Carcinoma
- Interventions
- Drug: Oral NKT2152
- Registration Number
- NCT05119335
- Lead Sponsor
- NiKang Therapeutics, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 128
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1 dose escalation Oral NKT2152 Phase 1 is designed to determine the maximum tolerated dose and/or identify the recommended Phase 2 dose of NKT2152 as a single agent administered orally once daily in ccRCC patients Phase 2 dose expansion Oral NKT2152 Phase 2 dose expansion will evaluate the safety, pharmacokinetics and antitumor efficacy of NKT2152 as a single agent administered orally once daily in ccRCC patients. Patients will be randomized to one of two dosage levels being evaluated.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) determined by the Investigator in the Dose Expansion Phase (Phase 2) Approximately 1 year ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Recommended Doses for Expansion (RDEs) Determined in the Dose Escalation Phase (Phase 1) Approximately 2 years The RDE(s) will be determined based on observed dose-limiting toxicities (DLTs) and using the totality of (AUC0-∞) and biological data in Phase 1.
Recommended Phase 2 Dose (RP2D) Approximately 1 year Further assess RDEs to determine the RP2D for NKT2152.
Number of Participants with Dose Limiting Toxicity (DLT) events during the DLT monitoring period (first 21 days of dosing) in the Dose Escalation Phase (Phase 1) 21 days DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0.
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration time curve (AUC0-t) of NKT2152 Up to Day 22 Area under the plasma concentration time curve (AUC0-t) of NKT2152.
Objective Response Rate (ORR) determined by the Investigator in the Dose Escalation Phase (Phase 1) Approximately 1 year ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Overall survival (OS) Through study completion, an average of 2 years OS defined as the time from the date the participant started study drug to death for any reason.
Number of Participants with Adverse Events Approximately 2 years An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related.
Maximum observed plasma concentration (Cmax) of NKT2152 Up to Day 22 Maximum observed plasma concentration (Cmax) of NKT2152
Time to maximum observed plasma concentration of NKT2152 (Tmax) Up to Day 22 Time to maximum observed plasma concentration of NKT2152 (Tmax)
Progression free survival (PFS) Through study completion, an average of 2 years PFS defined as the time from the date the participant started study drug to the date the participant experiences an event of disease progression or death.
Area under the plasma concentration time curve (AUC0-∞) of NKT2152 Up to Day 22 Area under the plasma concentration time curve (AUC0-∞) of NKT2152
Duration of response (DOR) Approximately 1 year Duration of overall response is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.
Disease control rate (DCR) determined by the Investigator Approximately 1 year DCR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) or a stable disease (SD) of 8 weeks or longer based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Trial Locations
- Locations (13)
HonorHealth
🇺🇸Scottsdale, Arizona, United States
UCLA
🇺🇸Los Angeles, California, United States
Sarah Cannon Research Institute
🇺🇸Denver, Colorado, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Indiana University Simon Comprehensive Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
National Cancer Institute
🇺🇸Bethesda, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States