The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
specified dose on specified days
specified dose on specified days
specified dose on specified days
Local Institution
Los Angeles, California, United States
Local Institution - 0003
Sacramento, California, United States
Local Institution - 0009
Aurora, Colorado, United States
Local Institution - 0002
St Louis, Missouri, United States
Incidence of Adverse Events (AEs)
Time frame: Up to 3 years
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 3 years
Incidence of AEs leading to dose and asset limiting toxicity (DALT)
Time frame: 8 weeks following initial dose
Incidence of AEs leading to discontinuation
Time frame: Up to 3 years
Incidence of laboratory abnormalities
Time frame: Up to 3 years
Change from baseline in programmed cell death receptor-ligand 1 (PD-L1) by immunohistochemistry (IHC)
Time frame: Day 0, Day 22, Day 50
Objective Response Rate (ORR)
Time frame: 24 weeks
Median duration of response (mDOR)
Time frame: 24 weeks
Progression-free survival rate (PFSR)
Time frame: 24 weeks
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Local Institution - 0008
New York, New York, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
Dallas, Texas, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States