This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
An immunoglobulin gamma (IgG1) antibody
Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
Local Institution - 165
Grand Rapids, Michigan, United States
START Midwest
Grand Rapids, Michigan, United States
Local Institution - 024
Southfield, Michigan, United States
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
Time frame: Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 2 years and 90 days
Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
Time frame: Day 1 Up to End of Treatment (up to 2 years)
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
Time frame: Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA
Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination
Time frame: Day 1 Up to End of Treatment (up to 2 years)
Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment
Time frame: From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity
Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment
Time frame: From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity
Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment
Time frame: From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.
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Local Institution - 072
Cincinnati, Ohio, United States
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
Lifespan Cancer Institute
Providence, Rhode Island, United States
Local Institution - 0001
Providence, Rhode Island, United States
Local Institution - 164
Dallas, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
...and 1 more locations
Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment
Time frame: From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.