The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: * Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors * Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Tablets administered orally
Administered intravenously
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada
Percentage of Participants With Treatment-emergent Adverse Events
Time frame: First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants With Treatment-emergent Serious Adverse Events
Time frame: First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Time frame: First dose date up to 3 weeks
Plasma Concentration of GS-9911
Time frame: Predose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: Cmax of GS-9911
Cmax is defined the maximum observed plasma drug concentration.
Time frame: Predose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-9911
Tmax is defined as the time to maximum observed concentration.
Time frame: Predose up to end of treatment (up to 105 weeks)
Area Under the Concentration-Time Curve (AUC) of GS-9911
AUC is defined as the area under the concentration versus time curve.
Time frame: Predose up to end of treatment (up to 105 weeks)
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