The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IU Simon Cancer Center
Indianapolis, Indiana, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Number of Participants with Dose Limiting Toxicities (DLTs)
Number of participants with DLTs
Time frame: Baseline through Cycle 1 (28 Day Cycle)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
PK: Cmax of LY3381916
Time frame: Predose Lead in Day 1 through Cycle 3 Day 1
PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
PK: AUC of LY3381916
Time frame: Predose Lead in Day 1 through Cycle 3 Day 1
PK: Cmax of LY3381916 Administered in Combination with LY3300054
PK: Cmax of LY3381916 administered in combination with LY3300054
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: AUC of LY3381916 Administered in Combination with LY3300054
PK: AUC of LY3381916 administered in combination with LY3300054
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: Cmax of LY3300054 Administered in Combination with LY3381916
PK: Cmax of LY3300054 administered in combination with LY3381916
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
PK: Cmin of LY3300054 administered in combination with LY3381916
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Finsen Institute
Copenhagen, Denmark
Gustave Roussy
Villejuif, France
Azienda Ospedaliera San Gerardo
Monza, Milano, Italy
Azienda Ospedaliera Umberto I
Ancona, Italy
...and 2 more locations
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
ORR: Percentage of participants with a CR or PR
Time frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Time to Response (TTR)
TTR
Time frame: Baseline to Date of CR or PR (Estimated up to 12 Months)
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
DCR: Percentage of participants who exhibit SD, CR or PR
Time frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Duration of Response (DOR)
DOR
Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Progression Free Survival (PFS)
PFS
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)