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Completed

NCT Number: NCT05826275

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

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Key information

Conditions

HPV Associated Cancers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TGN-S11

Drug

Small Molecule

Pembrolizumab

Drug

PD-1 checkpoint blockade

Other names: Keytruda

Primary outcomes

  1. 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.

Secondary outcomes

  1. PK Parameters to determine the single dose

    Time frame: 30 days

    Cmax

  2. Steady state pharmacokinetics (PK) of TGN-S11

    Time frame: 30 days

    AUC

Sponsors and collaborators

Lead sponsor

Toragen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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