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

NCT05826275 | Completed Phase 1 FDA Drug

• 1 other identifier: TGN-S11
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 5

Brief 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 checkpoint blockade.

Conditions

HPV Associated Cancers

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• PK Parameters to determine the single dose

  30 days

• Steady state pharmacokinetics (PK) of TGN-S11

  30 days

Study Arms (2)

Dose Escalation

EXPERIMENTAL

To determine the MTD in patients with HPV-associated cancers

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.

Drug: TGN-S11; Drug: Pembrolizumab

Interventions

TGN-S11 DRUG

Small Molecule

Dose Escalation; Dose Expansion

Pembrolizumab DRUG

PD-1 checkpoint blockade

Also known as: Keytruda

Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active CNS metastases
• Have any history of seizure disorder or are taking prophylactic seizure medication
• Have an active viral, bacterial, or fungal infection

Sponsors & Collaborators

• Toragen, Inc.: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10128, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Company Website

MeSH Terms

Interventions

pembrolizumab

Study Officials

• Neil J Clendeninn, MD, PhD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 24, 2023
• Study Start: June 20, 2023
• Primary Completion: May 28, 2025
• Study Completion: June 28, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (5)