Testing a new vaccine injection for HPV-related cancers

Plain-English translation of NCT07081984 on ClinicalTrials.gov ↗ · Source last updated November 2025 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This is an early-stage trial testing a new vaccine called TI-0093 designed to help treat certain cancers caused by HPV-16 that have returned or spread to other parts of the body. The vaccine works by training your immune system to recognize and fight cancer cells. Researchers want to learn if this treatment is safe, how well it works, and what side effects patients might experience.

Many people with HPV-related head and neck or cervical cancers that have come back or spread have few treatment options left after standard therapies stop working. This medication is being developed as a potential new option to help these patients by boosting their own immune system to fight the cancer.

Do you qualify?

You likely qualify if…

you have been diagnosed with an HPV-16 positive cancer (head and neck, cervical, or other solid tumors) that has come back or spread after previous treatments
you are between 18 and 75 years old
you are in good enough health to tolerate the treatment, with an expected life expectancy of at least 12 weeks
your blood cell counts and organ function (liver, kidney, heart) are at acceptable levels based on recent blood tests
you are willing to use effective contraception for 90 days after your last dose if you could become pregnant or father a child

You likely don't qualify if…

you have received any HPV vaccine in the past, or received any live vaccines in the 4 weeks before enrollment
you are pregnant, breastfeeding, or planning to become pregnant or donate eggs or sperm during the study and for 90 days after the last dose
you have a known allergy to any ingredients in the TI-0093 injection
you have another active cancer (other than certain skin cancers or early cervical cancer)
you have serious heart, liver, or kidney disease that would prevent you from safely receiving the treatment

What participation looks like

You will first go through a screening period (up to 28 days) with blood tests and exams to confirm you are eligible. If you qualify, you will receive five injections of the medication into your muscle on days 1, 8, 15, 29, and 43. Throughout the study, you will have regular visits for blood tests, physical exams, and imaging scans to check for side effects and whether your cancer is responding to the treatment. The study will monitor your safety closely, especially in the first 28 days after your first dose.

AI-generated summary from trial data · Jun 16, 2026 · Not medical advice

Trial locations(1 site)

China

Shanghai East Hospital, Shanghai