HPV Associated Cancers
Conditions
Brief summary
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.
Interventions
DRUGTGN-S11
Small Molecule
DRUGPembrolizumab
PD-1 checkpoint blockade
Sponsors
Toragen, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase I, dose escalation/dose expansion study. 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic * Life expectancy of at least 3 months * Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies
Exclusion criteria
* Active CNS metastases * Have any history of seizure disorder or are taking prophylactic seizure medication * Have an active viral, bacterial, or fungal infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | 12 months | To determine the maximum tolerated dose (MTD) of TGN-S11 in patients with human papillomavirus (HPV)-associated relapsed, resistant, or metastatic cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Parameters to determine the single dose | 30 days | Cmax |
| Steady state pharmacokinetics (PK) of TGN-S11 | 30 days | AUC |
Countries
United States
Outcome results
None listed