This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Domvanalimabis a fully human immunoglobulin G1 (IgG1) monoclonal antibody targeting human TIGIT
Zimbererlimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Affinity Health-Hope and Healing Cancer Services, LLC
Hinsdale, Illinois, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Number of Participants Treated with domvanalimab or domvanalimab in Combination with zimberelimab with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Time frame: From First Dose Date to 100 Days After Last Dose
AB154 Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of domvanalimab
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of zimberelimab
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Domvanalimab Time of Peak Concentration (Tmax)
Time of Peak Concentration (Tmax) of domvanalimab
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Time of Peak Concentration (Tmax)
Time of Peak Concentration (Tmax) of zimberelimab
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Domvanalimab Area Under the Plasma Concentration Versus Time Curve (AUC)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MD Anderson Cancer Center
Houston, Texas, United States
START
San Antonio, Texas, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, United States
The Kinghorn Cancer Centre - St Vincent Public Hospital
Darlinghurst, New South Wales, Australia
Tweed Hospital
Tweed Heads, New South Wales, Australia
Icon Cancer Care Brisbane
South Brisbane, Queensland, Australia
Olivia Newton-John Cancer Research Institute-Austin Hostipal
Heidelberg, Victoria, Australia
Area Under the Plasma Concentration Versus Time Curve (AUC) of domvanalimab
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Zimberelimab Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve (AUC) of zimberelimab
Time frame: Day 1 (sequential), Day 2, Day 3, Day 4, Day 8, Day 15, Day 22, Day 29 (sequential), Day 30, Day 31, Day 36, Day 43, Day 57, Day 64, Day 85, Day 106, Day 113, Day 141 and 30 Days After Last Dose, up to 52 weeks
Immunogenicity Indicators: Anti-Drug Antibodies (ADA)
Number of Participants who Develop Antidrug Antibodies to AB154 and/or AB122
Time frame: Day 1, Day 15, Day 29, Day 43, Day 57, Day 85 and 30 Days After Last Dose, up to 52 weeks
Overall Response Rate
Number of Participants with Complete or Partial Response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.1
Time frame: First Dose Date to Progression or Last Tumor Assessment, up to 1 year
Duration of Response
Time at Which Response Criteria are Met for Complete Response or Partial Response (Whichever Occurs First) Until the First Date of Recurrence, Progression or Death per RECIST v1.1
Time frame: Start Date of Response to First Progression/Death, up to 1 year
Disease Control Rate
Number of Participants with Complete Response, Partial Response, or Stable Disease for Greater Than 6 Months per RECIST v1.1
Time frame: First Dose Date to First Progression/Death, up to 1 year
Progression Free Survival
Number of Participants Without Disease Progression per RECIST v1.1
Time frame: First Dose Date to First Progression/Death, up to 1 year
Overall Survival
Overall Survival Rate, Defined as Time Between First Dose Date and Date of Death
Time frame: First Dose Date to Date of Death, up to 1 year