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
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of California at San Diego
San Diego, California, United States
RECRUITINGUCLA
Santa Monica, California, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
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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Emory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Louisville Brown Cancer Center
Louisville, Kentucky, United States
RECRUITINGOschner Health
New Orleans, Louisiana, United States
RECRUITINGSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGBarbara Ann Karmanos Cancer Center
Detroit, Michigan, United States
RECRUITING...and 19 more locations