This phase 2 study is designed to evaluate the safety and activity of TH-4000, a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.
An open label, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
University of Southern California-Norris
Los Angeles, California, United States
Stanford school of Medicine
Stanford, California, United States
Georgetown Medical Center
Washington D.C., District of Columbia, United States
Number of participants with response rate as evaluated by RECIST criteria
Time frame: Approximately 12 months
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose
Type of adverse events (AEs)
Time frame: Up to 30 days after last dose
Severity of adverse events (AEs)
Time frame: Up to 30 days after last dose
Duration of response (DOR) calculated for all patients achieving an objective response
Time frame: Approximately 12 months
Progression-free survival (PFS)
Time frame: Approximately 12 months
Overall Survival (OS)
Time frame: Approximately 12 months
Maximum plasma concentration of TH-4000 (prodrug) and TH-4000E (TKI effector)
Time frame: Cycle 1 Day 1 predose and up to 24 hours postdose
Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector)
Time frame: Cycle 1 Day 1 predose and up to 24 hours postdose
QTc Interval
Time frame: Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination
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University of Chicago
Chicago, Illinois, United States
Walter Reed National Military Cancer Center
Bethesda, Maryland, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Peter MacCallum
East Melbourne, Victoria, Australia