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Oral NKT2152 for Renal Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nebraska Cancer Specialists, Omaha, NERenal Cell Carcinoma+8 MoreOral NKT2152 - Drug
Eligibility
18+
All Sexes
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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.

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma
  • Kidney Cancer
  • Renal Cell Carcinoma Recurrent
  • Kidney Tumors
  • Refractory Renal Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Approximately 2 years

21 days
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)
Approximately 1 year
Disease control rate (DCR) determined by the Investigator
Duration of response (DOR)
Objective Response Rate (ORR) determined by the Investigator in the Dose Escalation Phase (Phase 1)
Objective Response Rate (ORR) determined by the Investigator in the Dose Expansion Phase (Phase 2)
Approximately 2 years
Number of Participants with Adverse Events
Recommended Phase 2 Dose (RP2D) Determined in the Dose Escalation Phase (Phase 1)
Year 2
Overall survival (OS)
Progression free survival (PFS)
Up to Day 22
Area under the plasma concentration time curve (AUC0-t) of NKT2152
Area under the plasma concentration time curve (AUC0-∞) of NKT2152
Maximum observed plasma concentration (Cmax) of NKT2152
Time to maximum observed plasma concentration of NKT2152 (Tmax)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
ALLO-316
1
CTX130
1
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Trial Design

2 Treatment Groups

Phase 2 dose expansion
1 of 2
Phase 1 dose escalation
1 of 2

Experimental Treatment

98 Total Participants · 2 Treatment Groups

Primary Treatment: Oral NKT2152 · No Placebo Group · Phase 1 & 2

Phase 2 dose expansion
Drug
Experimental Group · 1 Intervention: Oral NKT2152 · Intervention Types: Drug
Phase 1 dose escalation
Drug
Experimental Group · 1 Intervention: Oral NKT2152 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years

Who is running the clinical trial?

NiKang Therapeutics, Inc.Lead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least three more months.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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