Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer

September 2, 2025 updated by: Toragen, Inc.

A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City Of Hope
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • New York
      • New York, New York, United States, 10128
        • Icahn School Of Medicine At Mount Sinai
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
To determine the MTD in patients with HPV-associated cancers
Drug: TGN-S11
Small Molecule
Experimental: Dose Expansion
Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
Drug: TGN-S11
Small Molecule
Drug: Pembrolizumab
PD-1 checkpoint blockade
Other Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tolerated Dose
Time Frame: 12 months
To determine the maximum tolerated dose (MTD) of TGN-S11 in patients with human papillomavirus (HPV)-associated relapsed, resistant, or metastatic cancer.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK Parameters to determine the single dose
Time Frame: 30 days
Cmax
30 days
Steady state pharmacokinetics (PK) of TGN-S11
Time Frame: 30 days
AUC
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toragen, Inc.

Investigators

  • Study Director: Neil J Clendeninn, MD, PhD, Chief Medical Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

June 28, 2025

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGN-S11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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