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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | To determine the MTD in patients with HPV-associated cancers |
|
| Dose Expansion | Experimental | Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TGN-S11 | Drug | Small Molecule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameters to determine the single dose | Cmax | 30 days |
| Steady state pharmacokinetics (PK) of TGN-S11 | AUC | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil J Clendeninn, MD, PhD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| UCSD Moores Cancer Center |
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| Label | URL |
|---|---|
| Company Website | View source |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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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.
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| Pembrolizumab |
| Drug |
PD-1 checkpoint blockade |
|
|
| La Jolla |
| California |
| 92093 |
| United States |
| Yale University | New Haven | Connecticut | 06511 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10128 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |