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

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.

Timeline

Start

2025-11-11

Primary completion

2026-09-20

Completion

2027-07-31

Drugs

Indications