The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody. The primary objectives of this study are: * To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Administered intravenously
Administered intravenously.
The University of Washington/FHCC
Seattle, Washington, United States
The Ottawa Hospital
Ottawa, Canada
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada
Asan Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University Health Systems
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1
Barcelona, Spain
Hospital Universitari Vall D'Hebron- Oncology Service
Barcelona, Spain
START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I
Madrid, Spain
START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I
Madrid, Spain
...and 6 more locations
Percentage of Participants Experiencing Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: First dose date up to 90 days post last dose (Up to 24 months)
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to 4 weeks
Maximum Tolerable Dose (MTD) of GS-4528
Time frame: Day 1 up to 4 weeks
Pharmacokinetic (PK) parameter: Cmax of GS-4528 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody
Cmax is defined as the maximum observed concentration of drug.
Time frame: Predose on Day 1 and post dose up to end of treatment (EOT, Up to 24 months)
PK parameter: Cmin of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Cmin is defined as the minimum observed concentration of drug.
Time frame: Predose on Day 1 and post dose up to EOT (Up to 24 months)
PK parameter: AUC of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
AUC is defined as the area under the concentration versus time curve.
Time frame: Predose on Day 1 and post dose up to EOT (Up to 24 months)
Serum Concentrations of GS-4528 as Monotherapy and in Combination with Anti-PD-1 Monoclonal Antibody
Time frame: Predose on Day 1 and post dose up to EOT (Up to 24 months)
Percentage of Participants who Develop Antidrug Antibody (ADA) Against GS-4528
Time frame: Predose on Day 1 and post dose up to 60 day follow-up (Up to 24 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.