NCT07081984

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Therorna · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All potential study candidates will provide informed consent and undergo screening procedures to determine their study eligibility. After a screening period of up to 28 days, qualified patients will be enrolled to receive their assigned dose of TI-0093 injection. Patients will receive a total of five doses of TI-0093 administered muscularly on Day1, Day8, Day15, Day29 and Day43, respectively. Dose-limiting toxicities (DLTs) will be assessed for at least 28 days after the first dose of a given regimen. During the study, patients will be evaluated for safety, toxicity, immunogenicity, ORR, DOR, DCR, and PFS per protocol.

Conditions

• HPV 16+ Recurrent or Metastatic Cancer
• HNSCC
• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	therapeutic tumor vaccine	TI-0093 injection will be administered intramuscularly on Day1, Day8, Day15, Day29 and Day43.

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-09-20
• Completion: 2027-07-31
• First posted: 2025-07-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: China