Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer

Keywords

HPV Associated Cancers, Pembrolizumab, TGN-S11

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

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

Locations

  • UCSD Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Toragen, Inc.
Links
Company Website
ID
NCT05826275
Phase
Phase 1 Human Papillomavirus Research Study
Study Type
Interventional
Participants
Expecting 55 study participants
Last Updated