This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Small Molecule
PD-1 checkpoint blockade
City of Hope
Duarte, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Yale University
New Haven, Connecticut, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Maximum Tolerated Dose
To determine the maximum tolerated dose (MTD) of TGN-S11 in patients with human papillomavirus (HPV)-associated relapsed, resistant, or metastatic cancer.
Time frame: 12 months
PK Parameters to determine the single dose
Cmax
Time frame: 30 days
Steady state pharmacokinetics (PK) of TGN-S11
AUC
Time frame: 30 days
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MD Anderson Cancer Center
Houston, Texas, United States