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

No results posted yet for this study

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

Pembrolizumab

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826275 on ClinicalTrials.gov