Completed

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

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What is being tested

TGN-S11

+ Pembrolizumab

Drug
Who is being recruted

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2023
See protocol details

Summary

Principal SponsorToragen, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 20, 2023

Actual date on which the first participant was enrolled.

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.

Official TitleA Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
NCT05826275
Principal SponsorToragen, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
To determine the MTD in patients with HPV-associated cancers

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

City of Hope

Duarte, United StatesOpen City of Hope in Google Maps
Suspended

UCSD Moores Cancer Center

La Jolla, United States
Suspended

Yale University

New Haven, United States
Suspended

Icahn School of Medicine at Mount Sinai

New York, United States
Completed5 Study Centers