Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-22; most recent amendment 2025-11-21.
Status change: Enrolling by Invitation → Recruiting 2025-11-21
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-11-16
Trial Details
NCT Number NCT07081984
Lead Sponsor Therorna
Conditions HPV 16+ Recurrent or Metastatic Cancer, HNSCC, Cervical Cancer
Enrollment 12 participants
Start Date 2025-11-11
Primary Completion 2026-09-20 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-24