This study is currently recruiting participants.
Number
000580-C
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
No
Population Exclusion(s)
Fetuses;Pregnant Women;Children
Keywords
Kidney Cancer; Clear Cell Renal Cell Carcinoma; Kidney Neoplasms; Recurrent Renal Cell Carcinoma
Recruitment Keyword(s)
None
Condition(s)
Carcinoma, Renal Cell
Investigational Drug(s)
NKT2152
Investigational Device(s)
Intervention(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.
Objective:
To test a new drug (NKT2152) in people with advanced renal cancer.
Eligibility:
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.
Design:
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.
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Eligibility: -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)
-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)
Principal Investigator
Referral Contact
For more information: