Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer
NCT05826275 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-09-09
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.
Conditions
- HPV Associated Cancers
Interventions
- DRUG
-
TGN-S11
Small Molecule
- DRUG
-
PD-1 checkpoint blockade
Sponsors & Collaborators
-
Toragen, Inc.
lead INDUSTRY
Principal Investigators
-
Neil J Clendeninn, MD, PhD · Chief Medical Officer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-20
- Primary Completion
- 2025-05-28
- Completion
- 2025-06-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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