New drug combo shows promise for tough HPV cancers in early trial
NCT ID NCT05826275
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-phase trial tested a new drug called TGN-S11, alone and combined with the immunotherapy Keytruda, in 28 patients with advanced HPV-related cancers that had come back or spread. The main goal was to find a safe dose and see how the body handles the drug. Results will help decide if larger studies are worth doing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TGN-S11 (a small molecule drug) and pembrolizumab (Keytruda, an immunotherapy)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced HPV-related cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 28 participants, so it is primarily testing safety and dosing, not effectiveness. The drug may not work or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
28 people
The number who actually took part.
- Started
-
Jun 2023
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope
Duarte, California, 91010, United States
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Icahn School of Medicine at Mount Sinai
New York, New York, 10128, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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UCSD Moores Cancer Center
La Jolla, California, 92093, United States
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Yale University
New Haven, Connecticut, 06511, United States
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