TGN-S11 + Pembrolizumab for HPV-Associated Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, TGN-S11, combined with pembrolizumab (a PD-1 checkpoint inhibitor), for individuals with certain types of HPV-related cancers that have recurred, stopped responding to treatment, or spread. The trial aims to determine the safe dosage and effectiveness of the treatment when used with a PD-1 checkpoint blockade, which aids the immune system in fighting cancer. It is suitable for those with HPV-associated squamous cell carcinoma that hasn't responded to other treatments. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that TGN-S11 has been safe in earlier studies with patients who have HPV-related cancers. In one study, nine patients received TGN-S11 alone, and no safety problems were reported. Additionally, no serious side effects were linked to TGN-S11 when used by itself.
Pembrolizumab, a medicine already used for various conditions including cancers, is known to work well with other treatments for HPV-related cancers and typically does not cause many severe side effects.
When researchers studied TGN-S11 and pembrolizumab together, the results suggested that both treatments are generally safe for people. However, since this is an early phase trial, the main goal is to check safety and determine the right dose. While the early results appear promising, more research is needed to confirm these findings.12345Why do researchers think this study treatment might be promising for HPV-associated cancer?
Researchers are excited about TGN-S11 combined with Pembrolizumab for HPV-associated cancers because TGN-S11 introduces a novel approach by targeting cancer cells associated with the human papillomavirus (HPV). While standard treatments like chemotherapy and radiation work by broadly attacking cancer cells, TGN-S11 is designed to be more precise, potentially leading to fewer side effects. Additionally, when paired with Pembrolizumab, a PD-1 checkpoint inhibitor, the combination may enhance the immune system's ability to recognize and fight cancer cells, offering a promising new strategy for patients with HPV-related cancers.
What evidence suggests that TGN-S11 + Pembrolizumab could be an effective treatment for HPV-associated cancer?
Research has shown that TGN-S11, a treatment in this trial, has promising effects on cancers linked to HPV. In earlier studies, about one-third of patients who received only TGN-S11 experienced tumor shrinkage, indicating its potential to reduce cancer growth. Another treatment option in this trial, pembrolizumab, has also demonstrated strong results in various HPV-related cancers, with some patients having no detectable cancer after treatment. These findings support testing these treatments together in this trial, offering hope for patients with difficult-to-treat or advanced HPV-related cancers.678910
Who Is on the Research Team?
Neil J Clendeninn, MD, PhD
Principal Investigator
Chief Medical Officer
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
To determine the maximum tolerated dose (MTD) in patients with HPV-associated cancers
Dose Expansion
Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose Escalation with a PD-1 checkpoint blockade
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- TGN-S11
Find a Clinic Near You
Who Is Running the Clinical Trial?
Toragen, Inc.
Lead Sponsor