HPV Associated CancersPhase 1NCT05826275
Phase 1 Trial in Patients With Human Papillomavirus (HPV)-Associated Cancer
A Phase 1 study testing TGN-S11 and Pembrolizumab in people with HPV Associated Cancers, run by Toragen, Inc. at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV Associated Cancers
- What is being tested?
- TGN-S11 and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Jun 2023to 28 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active CNS metastases
- Have any history of seizure disorder or are taking prophylactic seizure medication
- Have an active viral, bacterial, or fungal infection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
UCSD Moores Cancer Center
La Jolla, California, 92093
Yale University
New Haven, Connecticut, 06511
Icahn School of Medicine at Mount Sinai
New York, New York, 10128
About this study
Official title: 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.
- Conditions
- HPV Associated Cancers
- Being tested
- TGN-S11, Pembrolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGN-S11Drug
Small Molecule
PembrolizumabDrug
Also called Keytruda
PD-1 checkpoint blockade
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | To determine the MTD in patients with HPV-associated cancers Receives: Drug: TGN-S11 |
| Dose Expansion | 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. Receives: Drug: TGN-S11; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
To determine the maximum tolerated dose (MTD) of TGN-S11 in patients with human papillomavirus (HPV)-associated relapsed, resistant, or metastatic cancer.
Measured: 12 months
Secondary outcomes (2)
PK Parameters to determine the single dose
Cmax
Measured: 30 days
Steady state pharmacokinetics (PK) of TGN-S11
AUC
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start20 Jun 2023
- Primary completion28 May 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV Associated CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Phase I, dose escalation/dose expansion study. 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toragen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neil J Clendeninn, MD, PhD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826275
- Sponsor's protocol ID
- TGN-S11
- Status last verified
- Sep 2025
- First submitted
- 29 Mar 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT05826275
- Acronym / sponsor ID
- TGN-S11
- Conditions
- HPV Associated Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Toragen, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I, dose escalation/dose expansion study. 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.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: TGN-S11To determine the MTD in patients with HPV-associated cancers |
| Dose Expansion | Experimental | Drug: TGN-S11, Drug: PembrolizumabDose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Active CNS metastases
- Have any history of seizure disorder or are taking prophylactic seizure medication
- Have an active viral, bacterial, or fungal infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TGN-S11Small Molecule | Drug | Dose Escalation, Dose Expansion |
| PembrolizumabAlso: KeytrudaPD-1 checkpoint blockade | Drug | Dose Expansion |
Primary outcome
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.
2 secondary outcomes
PK Parameters to determine the single dose
Time frame: 30 days
Steady state pharmacokinetics (PK) of TGN-S11
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Company WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil J Clendeninn, MD, PhD study director
Chief Medical Officer
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGN-S11 and Pembrolizumab in people with HPV Associated Cancers, run by Toragen, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.