TGN-S11 + Pembrolizumab for HPV-Associated Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Toragen, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

My cancer is HPV-related, has come back, is resistant, or has spread.

My condition worsened despite receiving standard treatments.

Life expectancy of at least 3 months

Exclusion Criteria

I have a history of seizures or am on seizure prevention medication.

I currently have an active infection.

My cancer has spread to my brain.

Participant Groups

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).

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