NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

A Phase 1/2, Open Label Dose-Escalation and Expansion Trial of Nkt2152, an Orally Administered Hif2a Inhibitor, to Investigate Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity in Patients with Advanced Clear Cell Renal Cell Carcinoma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Kidney Cancer;
Clear Cell Renal Cell Carcinoma;
Kidney Neoplasms;
Recurrent Renal Cell Carcinoma

Recruitment Keyword(s)



Carcinoma, Renal Cell

Investigational Drug(s)


Investigational Device(s)



Drug: NKT2152

Supporting Site

National Cancer Institute


In 2021, an estimated 76,080 new cases of kidney cancer were diagnosed in the United States. About 70% of all kidney cancers are clear cell renal cell cancer (ccRCC). The 5-year survival rate for localized or regional RCC is greater than 70%; however, if the disease has spread (metastasized) the 5-year survival rate is only 13%. Better treatments are needed for people with advanced renal cancer.


To test a new drug (NKT2152) in people with advanced renal cancer.


People aged 18 and older who have been diagnosed with advanced clear cell renal cancer and for whom standard treatment is no longer effective in treating it.


Participants will be screened. They will have a physical exam including a medication review. They will have blood and urine tests. Their ability to perform normal daily activities will be assessed. They will have tests of their heart function and imaging scans. They will give permission for researchers to access their previous biopsy results.

Participants will take the study drug by mouth once daily. Some will take the study drug only once a week.

Participants will visit the clinic once a week for the first 4 or 5 weeks; time between visits will gradually expand to once every 4 weeks for 1 year. Those who continue after 1 year will visit the clinic once every 12 weeks. Participants will visit the study site for two days for most visits.

Blood tests and scans will be repeated throughout the study period.

--Back to Top--



-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.

- Age >= 18 years with Eastern Cooperative Oncology Group performance status of 0-2 and life expectancy of >= 3 months

- Has adequate organ function defined as follows:

-- Bone marrow: ANC >= 1.0(SqrRoot) 109/L; hemoglobin level >= 10 g/dL without transfusion or erythropoietin support within 2 weeks prior to enrollment; platelet count >= 75,000/microL

-- Hepatic: transaminase levels (AST/ALT) <= 2.5 (SqrRoot) upper limit of normal (ULN) (<=5 (SqrRoot) ULN if liver metastases present); total bilirubin (TBILI) <= 2.0 mg/dL in the absence of Gilbert s disease

-- Renal: Serum creatinine level <= 2.0 X ULN or calculated creatinine clearance (CrCL) >= 40 mL/min (Cockcroft-Gault formula)

--Back to Top--


Not Provided

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Ramaprasad Srinivasan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 2-5950
(240) 760-6251

Sonia E. Bellfield, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 6B04
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6118

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


--Back to Top--