This study is NOT currently recruiting participants.
Number
000580-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing 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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INCLUSION CRITERIA: Patients must meet all of the following criteria to be enrolled in this study or in the sub-studies. -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 and has progressed during treatment with at least 1 prior therapeutic regimen -Must have measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1 -Is of age >= 18 years -Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 -Has a life expectancy of >= 3 months -Has adequate organ function defined as follows: --Bone marrow: ANC >= 1.0 x 10^9/L; hemoglobin level >= 10 g/dL without transfusion or erythropoietin support within 2 weeks prior to the first dose; platelet count >= 75,000/microliter --Hepatic: transaminase levels (AST/ALT) <= 2.5 x ULN (<= 5 x ULN if liver metastases is present); total bilirubin (TBILI) <= 1.5 x ULN 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) -If a female patient of child-bearing potential, has a negative serum pregnancy test result within 7 days before first study drug administration -If a female patient, must be surgically sterile, must be post-menopausal, or must agree to use physician-approved method of birth control during screening, during the study, and for a minimum of 6 months after the last study drug administration; or if a male patient with a female partner, must agree to use physician-approved method of birth control during screening, during the study, and for a minimum of 6 months after the last study drug administration -Female patients of childbearing potential must meet all of the following criteria: --Not pregnant (negative serum pregnancy test during Screening) --Not breastfeeding --Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse from the start of treatment or until at least 6 months after the last dose of treatment. Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin); or is menopausal (amenorrhea for >= 12 months). -Male patients who can father a child must meet all of the following criteria: --Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse with females of childbearing potential from the start of treatment until at least 6 months after the last dose of treatment, and --Willing to refrain from sperm donation from the start of treatment until at least 6 months after the last dose of treatment. Note: A male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy -Able to swallow oral medications. -Ambulatory subjects need to take a six-minute walk test. Walking distance needs to be at least 400 meters and the change of oxygen saturation needs to be within a 5% range. EXCLUSION CRITERIA: Patients will be excluded from this study or from the sub-studies if they meet any of the following 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. -Having one or more of the following conditions: --A pulse oximetry reading less than 95% at screening; --Any current requirement for intermittent or chronic supplemental oxygen; --Any chronic lung condition which has required supplemental oxygen in the past; --Evidence of impending airway compromise (such as endobronchial tumor, lymphangitic spread, significant extrinsic compression of major airway) per investigator; --Ascites requiring drainage within 28 days prior to W1D1 -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 NCI CTCAE; patients with treatable adverse effects such as hypothyroidism or hypertension may be enrolled if the adverse effect is controlled with treatment -Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of NKT2152 treatment; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy, symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; >= Grade 3 hypertension (diastolic blood pressure >= 100 mmHg or systolic blood pressure >=160 mmHg) despite adequate use of anti-hypertensives; or history of congenital prolonged QT syndrome or repeated demonstration of a QTc interval > 480 ms; ejection fraction < 40%; clinically significant pericardial or pleural effusion in the opinion of the investigator -Has received prior investigational therapy or standard therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter -Has a bleeding diathesis or coagulopathy -Deep vein thrombosis (DVT)/pulmonary embolism are allowed as long as patient is not symptomatic and received 2 weeks or more of adequate anticoagulation -Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease -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 had major surgery within 4 weeks before first study drug administration; the following procedures are not considered to be major surgeries: thoracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic or ultrasonographic procedures, mediastinoscopy, skin biopsy, incisional biopsy, image-guided biopsy for diagnostic purposes, and routine dental procedures -Has known human immunodeficiency virus (HIV) -Has an active infection requiring systemic treatment -Is actively participating in another therapeutic clinical trial -Has received prior treatment with a HIF2alpha inhibitor (unless participating in the substudy that requires previous belzutifan treatment)
Patients must meet all of the following criteria to be enrolled in this study or in the sub-studies.
-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 and has progressed during treatment with at least 1 prior therapeutic regimen
-Must have measurable disease per the Response Evaluation Criteria in Solid Tumors version 1.1
-Is of age >= 18 years
-Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
-Has a life expectancy of >= 3 months
-Has adequate organ function defined as follows:
--Bone marrow: ANC >= 1.0 x 10^9/L; hemoglobin level >= 10 g/dL without transfusion or erythropoietin support within 2 weeks prior to the first dose; platelet count >= 75,000/microliter
--Hepatic: transaminase levels (AST/ALT) <= 2.5 x ULN (<= 5 x ULN if liver metastases is present); total bilirubin (TBILI) <= 1.5 x ULN 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)
-If a female patient of child-bearing potential, has a negative serum pregnancy test result within 7 days before first study drug administration
-If a female patient, must be surgically sterile, must be post-menopausal, or must agree to use physician-approved method of birth control during screening, during the study, and for a minimum of 6 months after the last study drug administration; or if a male patient with a female partner, must agree to use physician-approved method of birth control during screening, during the study, and for a minimum of 6 months after the last study drug administration
-Female patients of childbearing potential must meet all of the following criteria:
--Not pregnant (negative serum pregnancy test during Screening)
--Not breastfeeding
--Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse from the start of treatment or until at least 6 months after the last dose of treatment.
Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy; has medically documented ovarian failure (with serum estradiol and follicle-stimulating hormone levels within the institutional laboratory postmenopausal range and a negative serum or urine beta human chorionic gonadotropin); or is menopausal (amenorrhea for >= 12 months).
-Male patients who can father a child must meet all of the following criteria:
--Willing to use a protocol-recommended method of contraception or to abstain from heterosexual intercourse with females of childbearing potential from the start of treatment until at least 6 months after the last dose of treatment, and
--Willing to refrain from sperm donation from the start of treatment until at least 6 months after the last dose of treatment.
Note: A male patient is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy
-Able to swallow oral medications.
-Ambulatory subjects need to take a six-minute walk test. Walking distance needs to be at least 400 meters and the change of oxygen saturation needs to be within a 5% range.
EXCLUSION CRITERIA:
Patients will be excluded from this study or from the sub-studies if they meet any of the following 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.
-Having one or more of the following conditions:
--A pulse oximetry reading less than 95% at screening;
--Any current requirement for intermittent or chronic supplemental oxygen;
--Any chronic lung condition which has required supplemental oxygen in the past;
--Evidence of impending airway compromise (such as endobronchial tumor, lymphangitic spread, significant extrinsic compression of major airway) per investigator;
--Ascites requiring drainage within 28 days prior to W1D1
-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 NCI CTCAE; patients with treatable adverse effects such as hypothyroidism or hypertension may be enrolled if the adverse effect is controlled with treatment
-Significant cardiovascular disease, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months prior to start of NKT2152 treatment; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy, symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; >= Grade 3 hypertension (diastolic blood pressure >= 100 mmHg or systolic blood pressure >=160 mmHg) despite adequate use of anti-hypertensives; or history of congenital prolonged QT syndrome or repeated demonstration of a QTc interval > 480 ms; ejection fraction < 40%; clinically significant pericardial or pleural effusion in the opinion of the investigator
-Has received prior investigational therapy or standard therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter
-Has a bleeding diathesis or coagulopathy
-Deep vein thrombosis (DVT)/pulmonary embolism are allowed as long as patient is not symptomatic and received 2 weeks or more of adequate anticoagulation
-Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease
-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 had major surgery within 4 weeks before first study drug administration; the following procedures are not considered to be major surgeries: thoracentesis, port placement, laparoscopy, thoracoscopy, bronchoscopy, endoscopic or ultrasonographic procedures, mediastinoscopy, skin biopsy, incisional biopsy, image-guided biopsy for diagnostic purposes, and routine dental procedures
-Has known human immunodeficiency virus (HIV)
-Has an active infection requiring systemic treatment
-Is actively participating in another therapeutic clinical trial
-Has received prior treatment with a HIF2alpha inhibitor (unless participating in the substudy that requires previous belzutifan treatment)
Principal Investigator
Referral Contact
For more information: