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

Phase 1

Active, not recruiting

• Conditions: HPV Associated Cancers
• Interventions: Drug: TGN-S11; Drug: Pembrolizumab

• Registration Number: NCT05826275
• Lead Sponsor: Toragen, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-24
• Study Start: 2023-06-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation	TGN-S11	To determine the MTD in patients with HPV-associated cancers
Dose Expansion	TGN-S11	Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
Dose Expansion	Pembrolizumab	Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose	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 Outcome Measures

Name	Time	Method
PK Parameters to determine the single dose	30 days	Cmax
Steady state pharmacokinetics (PK) of TGN-S11	30 days	AUC

Trial Locations

Locations (5)

City of Hope; 🇺🇸 Duarte, California, United States

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States