NCT05222932

Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1

A Phase I Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and IL-2 Coding Oncolytic Adenovirus TILT-123 and Avelumab in Solid Tumor Patients (Melanoma and SCCHN) Refractory to or Progressing After Anti-PD(L)1

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: TILT Biotherapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, dose-escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with avelumab in patients with advanced solid tumors refractory to or progressing after anti-PD(L)1.

Detailed description

This is an open-label, phase 1, dose-escalation trial evaluating the safety of TILT-123 TILT-123 in combination with avelumab in patients with advanced solid tumors (SCCHN and melanoma) refractory to or progressing after anti-PD(L)1. TILT-123 is an oncolytic adenovirus coding for tumor necrosis factor alpha and interleukin 2. The trial is conducted in Helsinki (Finland).

Conditions

• Melanoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	TILT-123	TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
DRUG	Avelumab	Anti-PDL1 antibody

Timeline

• Start date: 2023-03-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-02-03
• Last updated: 2025-08-07

Locations

2 sites across 2 countries: United States, Finland