The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are: * The recommended doses (RDs) * The safety and tolerability * The PK and the preliminary efficacy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Specified doses on specified days
Specified doses on specified days
Specified doses on specified days
Exelixis Site #8
Los Angeles, California, United States
Exelixis Site #9
Miami, Florida, United States
Exelixis Clinical Site #1
Orlando, Florida, United States
Exelixis Site #11
Tampa, Florida, United States
Exelixis Site #6
Scarborough, Maine, United States
Exelixis Site #5
St Louis, Missouri, United States
Exelixis Clinical Site #3
New Hyde Park, New York, United States
Exelixis Site #14
New York, New York, United States
Exelixis Site #13
Shirley, New York, United States
Exelixis Site #15
The Bronx, New York, United States
...and 4 more locations
Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 24 months
Expansion Stage: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the Investigator
Time frame: Up to 24 months
Dose-finding Stage: Number of participants with adverse events (AEs), including serious adverse events (SAEs) and immune-mediated adverse events (imAEs)
Time frame: Up to 24 months
Dose-finding Stage: Concentration of study treatments (zanzalintinib and AB521) in plasma at specified time points
Time frame: Up to 24 months
Dose-finding Stage: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the Investigator
Time frame: Up to 24 months
Expansion Stage: Number of participants with adverse events (AEs), including serious adverse events (SAEs), and immune-mediated adverse events (imAEs)
Time frame: Up to 24 months
Expansion Stage: Duration of response (DOR) per RECIST 1.1 as assessed by the Investigator
Time frame: Up to 24 months
Expansion Stage: Progression-free survival (PFS) per RECIST 1.1 as assessed by the Investigator
Time frame: Up to 24 months
Expansion Stage: Overall survival (OS)
Time frame: Up to 24 months
Expansion Stage: Concentration of study treatments (zanzalintinib and AB521) in plasma at specified time points
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.