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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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Renal Cell Carcinoma (RCC) include checkpoint inhibitors, VEGF inhibitors, and mTOR inhibitors. Checkpoint inhibitors, such as nivolumab and pembrolizumab, work by blocking proteins that prevent the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. VEGF inhibitors, like sunitinib and axitinib, inhibit the vascular endothelial growth factor, which tumors use to develop new blood vessels, thus starving the tumor of nutrients and oxygen. mTOR inhibitors, such as everolimus, block the mTOR pathway, which is involved in cell growth and proliferation. These treatments are crucial for RCC patients as they target specific pathways that the cancer cells rely on for growth and survival. The trial NKT2152, a HIF2α inhibitor, represents a novel approach by targeting hypoxia-inducible factors, which are also critical in RCC progression, potentially offering another effective treatment option.
Is there a role for adjuvant therapy after surgery in "high risk for recurrence" kidney cancer? An update on current concepts.The future of tyrosine kinase inhibitors: single agent or combination?

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
~8 spots leftby Sep 2024
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