This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
TAS266 IV infusions given weekly
H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC
Tampa, Florida, United States
South Texas Accelerated Research Therapeutics START
San Antonio, Texas, United States
University of Utah / Huntsman Cancer Institute Huntsman UT
Salt Lake City, Utah, United States
Frequency and characteristics of Dose limiting toxicities at each dose level
Time frame: 2 years
Type, frequency, and severity of AEs, changes in laboratory and clinical assessments
Time frame: 2 years
TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266
1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment
Time frame: 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment
Presence and concentration of anti-TAS266 antibodies
Time frame: 2 Years
Tumor response
Time frame: 2 Years
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