This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
UH Cleveland Medical Center
Cleveland, Ohio, United States
NOT_YET_RECRUITINGPASO Medical
Frankston, Victoria, Australia
NOT_YET_RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
RECRUITINGIncidence of Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs)
Time frame: From baseline through study completion, an average of 12 months
Recommended Dose for Expansion (RDE) Determination
Time frame: From baseline through study completion, an average of 12 months
Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Disease Control Rate (DCR)
Time frame: Up to approximately 30 months
Preliminary Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Preliminary Disease Control Rate (DCR)
Time frame: Up to approximately 30 months
Incidence of Anti-Drug Antibodies (ADA)
Time frame: From baseline through study completion, an average of 12 months
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Seoul National University Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGSamsung Medical Center
Seoul, South Korea
NOT_YET_RECRUITING