RecruitingPhase 1NCT07081984

Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of TI-0093 Injection in Patients With Recurrent/Metastatic HPV-16 Positive Solid Tumors


Sponsor

Therorna

Enrollment

12 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, open-label, dose escalation study to assess the safety, tolerability, efficacy and immunogenicity of TI-0093 injection in patients with recurrent or metastatic HPV-16 positive solid tumors. The primary objectives of the study are to assess safety and tolerability of TI-0093 injection in patients with recurrent or metastatic solid tumors, and to determine the maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of TI-0093 injection.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new therapeutic vaccine called TI-0093 in people with cancers caused by HPV-16 (a strain of the human papillomavirus) that have returned or spread, including cancers of the head and neck, cervix, and other sites. The vaccine is designed to train the immune system to recognize and destroy HPV-16-infected cancer cells. **You may be eligible if...** - You are between 18 and 75 years old with confirmed HPV-16 positive cancer - Your cancer is recurrent or metastatic and has progressed after standard treatment options - You are in good general health (ECOG 0–1) and have at least one measurable tumor - Your blood counts, liver, kidney, and heart function meet required thresholds **You may NOT be eligible if...** - You have previously received an HPV vaccine for therapeutic purposes - You have active brain metastases, recent major surgery, deep vein clots, or active bleeding - You have active autoimmune disease, serious heart conditions, uncontrolled diabetes, or active infections (including HIV, hepatitis B, hepatitis C, or tuberculosis) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALtherapeutic tumor vaccine

TI-0093 injection will be administered intramuscularly on Day1, Day8, Day15, Day29 and Day43.


Locations(1)

Shanghai East Hospital

Shanghai, China

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NCT07081984


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