The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Administered IV.
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The START Center for Cancer Care
San Antonio, Texas, United States
Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)
Recommended Phase 2 Dose of LY3164530: MTD
Time frame: Cycle 1 (Cycle = 28 days)
Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay
Cmax in Schedule (Sched) 1 Cycle 1 (C1) and Cycle 2 (C2) and Sched. 2 C1 and C2 dose escalation based on EGFR specific ELISA assay. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay
Cmax in Schedule 1 Cycles 1 and 2 and Schedule 2 Cycles 1 and 2 based on the MET-specific ELISA assay. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
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Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) \[Schedule 1\] or from time 0-168 hours (τ) \[Schedule 2\]. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay
Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC\[0-τ\]) from time 0 to 336 hours (τ) \[Schedule 1\] or from time 0-168 hours (τ) \[Schedule 2\]. Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion. PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion.
Time frame: Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)
Number of Participants With Tumor Response
Number of Participants with Tumor Response
Time frame: Baseline Through Study Completion (Up to 6 Months)