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Virus Therapy

TGN-S11 + Pembrolizumab for HPV-Associated Cancer

Phase 1
Recruiting
Research Sponsored by Toragen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination therapy for HPV-associated cancers which have not responded to other treatments.

Who is the study for?
This trial is for people with HPV-related squamous cell carcinoma that has come back, stopped responding to treatment, or spread. Participants must have a life expectancy of at least 3 months and should have seen their cancer progress after standard treatments.
What is being tested?
The study is testing TGN-S11 in combination with Pembrolizumab. It's an early-phase trial where the safety of increasing doses will be assessed first (Dose Escalation), followed by further evaluation at a safe dose level alongside an immune checkpoint inhibitor (Expansion Phase).
What are the potential side effects?
Possible side effects may include typical reactions to immunotherapy such as fatigue, skin reactions, flu-like symptoms, and potential autoimmune responses where the body attacks its own cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Tolerated Dose
Secondary study objectives
PK Parameters to determine the single dose
Steady state pharmacokinetics (PK) of TGN-S11

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment2 Interventions
Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
Group II: Dose EscalationExperimental Treatment1 Intervention
To determine the MTD in patients with HPV-associated cancers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Toragen, Inc.Lead Sponsor
Neil J Clendeninn, MD, PhDStudy DirectorChief Medical Officer
Neil J Clendennin, MD, PhDStudy DirectorChief Medical Officer

Media Library

TGN-S11 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05826275 — Phase 1
Cancer Research Study Groups: Dose Escalation, Dose Expansion
Cancer Clinical Trial 2023: TGN-S11 Highlights & Side Effects. Trial Name: NCT05826275 — Phase 1
TGN-S11 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05826275 — Phase 1
~22 spots leftby Dec 2025
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