The primary objective of this study is to determine the recommended dose(s) of PYX-106 in participants with relapsed/refractory solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Intravenous (IV) infusion
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of California San Diego
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)
Time frame: Day 1 to Day 28
Number of Participants Who Experience an Adverse Event (AE)
Type, incidence, seriousness and causality of AEs based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. Any clinically significant changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) parameters will be recorded as AEs.
Time frame: Day 1 up to approximately 19 months
Maximum Concentration (Cmax) of PYX-106
Time frame: Day 1 up to approximately 2 years
Time to Maximum Concentration (Tmax) of PYX-106
Time frame: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the Last Quantifiable Concentration (AUC0-t) of PYX-106
Time frame: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 to the End of the Dosing Interval (AUCtau) of PYX-106
Time frame: Day 1 up to approximately 2 years
Area Under the Time Concentration Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of PYX-106
Time frame: Day 1 up to approximately 2 years
Half Life (t1/2) of PYX-106
Time frame: Day 1 up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Day 1 up to approximately 2 years
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La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
SCRI- HealthOne Denver
Denver, Colorado, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago Medicine
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Gabrail Cancer and Research Center
Canton, Ohio, United States
Lifespan - Rhode Island Hospital
Providence, Rhode Island, United States
NEXT Oncology
Irving, Texas, United States
...and 10 more locations
Duration of Response (DOR)
Time frame: Day 1 up to approximately 2 years
Progression Free Survival (PFS)
Time frame: Day 1 up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Day 1 up to approximately 2 years
Time to Response
Time frame: Day 1 up to approximately 2 years
Overall Survival (OS)
Time frame: Day 1 up to approximately 2 years