The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Oral administration
START Dallas
Fort Worth, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITINGNumber of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Number of Participants with Dose-limiting Toxicity (DLT)
Time frame: Up to 28 days
Number of Participants with Dose Interruptions and Dose Modifications
Time frame: Up to 3 years
Maximum Concentration (Cmax) of EXS74539
Time frame: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)
Time to Cmax (tmax) of EXS74539
Time frame: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)
Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) of EXS74539
Time frame: Cycle 1 Day 1 through end of treatment (up to approximately 3 years)
Objective Response Rate (ORR)
Time frame: Up to 3 years
Duration of Response (DoR)
Time frame: Up to 3 years
Progression-free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
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