The primary purpose of this study is to determine the pediatric maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and to evaluate the safety and tolerability of zanzalintinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Administered as specified in the treatment arm.
Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Up to Day 28
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 8 months
Area Under the Concentration-Time Curve (AUC) of Zanzalintinib
Time frame: From Week 1 Day 1 to Week 21 Day 1
Maximum Plasma Concentration (Cmax) of Zanzalintinib
Time frame: From Week 1 Day 1 to Week 21 Day 1
Time to Maximum Plasma Concentration (Tmax) of Zanzalintinib
Time frame: From Week 1 Day 1 to Week 21 Day 1
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