AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously. Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Antibody Drug Conjugate
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGFlorida Cancer Specialist
Sarasota, Florida, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGSarah Cannon Research Center
Nashville, Tennessee, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGNEXT Oncology
Fairfax, Virginia, United States
RECRUITINGAcceptable maximum tolerated dose for participants
Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized
Time frame: 21 days following the first dose of AGX101 (Day 1 through Day 21)
Number of participants with adverse events
Evaluation of the incidence, severity, and duration of adverse events
Time frame: Screening through end of treatment, approximately 6 months and up to 3 years
Terminal elimination half life (PK)
Determination of the terminal elimination half-life (t½)
Time frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
AUC (PK)
Determination of the AUC in 1 dosing interval
Time frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Cmax (PK)
Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state
Time frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Number of Participants with Antidrug Antibodies (ADA) to AGX101
Incidence and titers of ADA will be measured
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator
Determination the objective response rate (ORR)
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Response (DoR) Assessed by Investigator
Determination of the duration of response (DoR)
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Disease Control Rate (DCR)
Determination of the disease control rate (DCR)
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator
Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).
Time frame: Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Treatment
Time frame: Approximately 6 months and up to 3 years
Overall Survival
Time frame: Approximately 6 months and up to 3 years
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