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HIF2α Inhibitor

Oral NKT2152 for Kidney Cancer

Phase 1 & 2

Recruiting

Research Sponsored by NiKang Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is of age ≥ 18 years

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Study Summary

This trial will test a new drug for kidney cancer. The first part will find the best dose of the drug, and the second part will see if it works.

Who is the study for?

Adults (18+) with advanced clear cell renal cell carcinoma (ccRCC) that has worsened despite treatment can join. They must be able to swallow pills, have measurable disease, an ECOG status of 0-2, and a life expectancy over 3 months. Women must not be pregnant or breastfeeding and use birth control; men also need to agree to birth control measures.Check my eligibility

What is being tested?

The trial is testing NKT2152, a HIF2α inhibitor for kidney cancer. The first phase determines the highest dose patients can take without serious side effects. The second phase checks how well it works in treating ccRCC.See study design

What are the potential side effects?

Specific side effects of NKT2152 are not listed but may include typical reactions to oral cancer medications such as nausea, fatigue, liver issues, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of the day.

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I can walk 400 meters in 6 minutes without my oxygen levels changing by more than 5%.

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My blood, liver, and kidney functions meet the required levels for the trial.

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I can take pills by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Objective Response Rate (ORR) determined by the Investigator in the Dose Expansion Phase (Phase 2)

Recommended Doses for Expansion (RDEs) Determined in the Dose Escalation Phase (Phase 1)

+1 more

Secondary outcome measures

Area under the plasma concentration time curve (AUC0-t) of NKT2152

Area under the plasma concentration time curve (AUC0-∞) of NKT2152

Disease control rate (DCR) determined by the Investigator

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 dose expansionExperimental Treatment1 Intervention

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.

Group II: Phase 1 dose escalationExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NiKang Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

262 Total Patients Enrolled

Media Library

Renal Cell Carcinoma Clinical Trial 2023: NKT2152 Highlights & Side Effects. Trial Name: NCT05119335 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any slots left in this experiment accessible to participants?

"Correct. According to data hosted on clinicaltrials.gov, this medical study that was initially advertised on October 26th 2021 is currently searching for participants. A total of 98 patients are sought from 7 different centres."

Answered by AI

What is the current population enrolled in this clinical research?

"Affirmative, the trial is actively seeking enrollees. The posting was initially put up on October 26th 2021 and most recently updated on October 17th 2022. This initiative requires 98 participants from 7 different clinical sites to reach completion."

Answered by AI

Are there any Canadian locations conducting this medical experiment?

"This clinical trial is being conducted in multiple locations, such as the National Cancer Institute in Bethesda and MD Anderson Cancer Center in Houston. Additionally, sites at Dana Farber Cancer Institute (Boston) and 7 other centers are included."

Answered by AI

What outcome is this trial aiming to demonstrate?

"According to the study sponsor, NiKang Therapeutics Inc., this clinical trial will measure a primary outcome of Objective Response Rate (ORR) over 21 days during the Dose Expansion Phase (Phase 2). The investigation will also gauge secondary outcomes such as Overall Survival (OS), which is measured from commencement of treatment until death due to any cause, Disease Control Rate (DCR), and Time To Maximum Observed Plasma Concentration Of NKT2152(Tmax)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma

2021. "A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05119335.

All > Renal Cancer > Renal Cell Carcinoma