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
Therorna
12 participants
Nov 11, 2025
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
Plain Language Summary
Simplified for easier understanding
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
TI-0093 injection will be administered intramuscularly on Day1, Day8, Day15, Day29 and Day43.
Locations(1)
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NCT07081984