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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05119335
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
NiKang Therapeutics, Inc.

Brief Summary:
The goal of the Phase 1 portion is to identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 Dose (RP2D) of NKT2152. The Phase 2 portion will evaluate the efficacy of NKT2152 in ccRCC.

Condition or disease Intervention/treatment Phase
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 Drug: Oral NKT2152 Phase 1 Phase 2

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. Eligible patients will have received <=4 prior lines lines of therapy.

Phase 1 is designed to determine the MTD and/or RP2D 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1 dose escalation and Phase 2 dose expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 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
Actual Study Start Date : October 26, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2026


Arm Intervention/treatment
Experimental: Phase 1 dose escalation
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
Drug: Oral NKT2152
Oral HIF2α inhibitor

Experimental: Phase 2 dose expansion
Phase 2 will evaluate the safety, pharmacokinetics and antitumor efficacy of NKT2152 as a single agent administered orally once daily in ccRCC patients
Drug: Oral NKT2152
Oral HIF2α inhibitor




Primary Outcome Measures :
  1. 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) [ Time Frame: 21 days ]
    DLTs graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 .0.

  2. Recommended Phase 2 Dose (RP2D) Determined in the Dose Escalation Phase (Phase 1) [ Time Frame: Approximately 2 years ]
    The RP2D will be determined based on observed dose-limiting toxicities (DLTs) and using the totality of PK and biological data in Phase 1.

  3. Objective Response Rate (ORR) determined by the Investigator in the Dose Expansion Phase (Phase 2) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: 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.

  2. Area under the plasma concentration time curve (AUC0-t) of NKT2152 [ Time Frame: Up to Day 22 ]
    Area under the plasma concentration time curve (AUC0-t) of NKT2152.

  3. Area under the plasma concentration time curve (AUC0-∞) of NKT2152 [ Time Frame: Up to Day 22 ]
    Area under the plasma concentration time curve (AUC0-∞) of NKT2152

  4. Maximum observed plasma concentration (Cmax) of NKT2152 [ Time Frame: Up to Day 22 ]
    Maximum observed plasma concentration (Cmax) of NKT2152

  5. Time to maximum observed plasma concentration of NKT2152 (Tmax) [ Time Frame: Up to Day 22 ]
    Time to maximum observed plasma concentration of NKT2152 (Tmax)

  6. Objective Response Rate (ORR) determined by the Investigator in the Dose Escalation Phase (Phase 1) [ Time Frame: 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.

  7. Duration of response (DOR) [ Time Frame: 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.

  8. Disease control rate (DCR) determined by the Investigator [ Time Frame: 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.

  9. Progression free survival (PFS) [ Time Frame: 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.

  10. Overall survival (OS) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has the ability to understand and willingness to sign a written informed consent form before the performance of any study procedures
  • Has locally advanced or metastatic ccRCC and has progressed during treatment, are relapsed, refractory and not amenable to curative therapy or standard therapy (Phase 1); has progressed during treatment with at least 1 prior therapeutic regimen (Phase 2) that contains a PD-1 or PD-L1 compound and/or a VEGF targeting agent, and a total of ≤ 4 prior therapeutic regimens.
  • Must have measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
  • Is of age ≥ 18 years
  • Has an Eastern Cooperative Oncology Group performance status of 0-2
  • Has a life expectancy of ≥ 3 months
  • Has adequate organ function

Exclusion Criteria:

  • Known symptomatic brain metastases requiring >10 mg/day of prednisone (or its equivalent). Patients with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of NKT2152 treatment, fulfill the above steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥4 weeks after CNS-directed treatment.
  • Has a pulse oximetry reading less than 92% at screening, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
  • History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage 1 or stage 2 cancers currently in complete remission, or any other cancer that has been in complete remission for ≥2 years
  • Has failed to recover from the effects of prior anticancer therapy to baseline level or grade 1 severity (except for alopecia) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); patients with treatable adverse effects such as hypothyroidism or hypertension may be enrolled if the adverse effect is controlled with treatment
  • Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
  • Has received prior treatment with a HIF2α inhibitor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05119335


Contacts
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Contact: Tracy Bortoli 302-415-5127 clinicaltrials@nikangtx.com
Contact: Heather Askew 615-626-5084 clinicaltrials@nikangtx.com

Locations
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United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Michael Gordon, MD         
United States, Colorado
Sarah Cannon Research Institute Recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Gerald Falchook, MD         
United States, Indiana
Indiana University Simon Comprehensive Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Theodore Logan, MD         
Principal Investigator: Theodore Logan, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Toni Choueiri, MD         
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Ralph Hauke, MD    402-334-4773    rhauke@nebraskacancer.com   
Principal Investigator: Ralph Hauke, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Eric Jonasch, MD         
Sponsors and Collaborators
NiKang Therapeutics, Inc.
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Responsible Party: NiKang Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05119335    
Other Study ID Numbers: NKT2152-101
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD are not planned to be shared at this time

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NiKang Therapeutics, Inc.:
HIF2α
NKT2152
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases