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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

Study 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.Check my eligibility

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).See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose

Secondary outcome measures

PK Parameters to determine the single dose

Steady state pharmacokinetics (PK) of TGN-S11

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 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Toragen, Inc.Lead Sponsor

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment available at the present moment?

"According to the records on clinicaltrials.gov, recruitment for this trial has concluded since its last update in April 25th of 2023. The study was initially posted June 1st 2023 and is no longer accepting patients; however, there are other trials currently seeking volunteers."

Answered by AI