The purpose of this study is to evaluate the safety and tolerability of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
362
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Research Site
Birmingham, Alabama, United States
RECRUITINGResearch Site
San Diego, California, United States
RECRUITINGResearch Site
Santa Monica, California, United States
RECRUITINGResearch Site
Miami, Florida, United States
RECRUITINGResearch Site
Atlanta, Georgia, United States
RECRUITINGResearch Site
Louisville, Kentucky, United States
RECRUITINGResearch Site
New Orleans, Louisiana, United States
RECRUITINGResearch Site
Baltimore, Maryland, United States
RECRUITINGResearch Site
Boston, Massachusetts, United States
RECRUITINGResearch Site
Detroit, Michigan, United States
RECRUITING...and 15 more locations
Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to 4 months
Number of participants with adverse events (AEs)
Time frame: Up to 4 months
Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 4 months
Plasma concentration of casdatifan
Time frame: Up to 4 months
Area under the plasma concentration time curve (AUC) of casdatifan
Time frame: Up to 4 months
Maximum Observed Plasma Concentration (Cmax) of casdatifan
Time frame: Up to 4 months
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