A Phase 1, Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Patients with Injectable Solid Tumors.

Phase 1

Not yet recruiting

• Conditions: Solid Tumors

• Registration Number: 2024-520258-39-00
• Lead Sponsor: TILT Biotherapeutics Oy

Brief Summary

This is an open-label, phase 1, dose-escalation, multicenter trial evaluating the safety of oncolytic adenovirus TILT-123 as monotherapy in advanced solid tumor patients.

Detailed Description

This is an open-label, phase 1, dose-escalation trial evaluating the safety of TILT-123 as monotherapy in advanced solid tumor patients. TILT-123 is an oncolytic adenovirus coding for tumor necrosis factor alpha and interleukin 2. The trial includes 2 healthcare centers in Helsinki (Finland). Patients with different indications are expected to be treated in the trial.

Study Timeline

• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants with vital sign abnormalities.	85 days	Safety (III)
Number of Participants with Adverse Events assessed by 12- lead electrocardiograms (ECGs)	85 days	Safety (IV)
Number of Participants with any (serious and non-serious) Adverse Events.	85 days	Safety (I)
Number of Participants with abnormal laboratory values.	85 days	Safety (II)

Trial Locations

Locations (2)

HUS-Yhtymae; 🇫🇮 Helsinki, Finland

Docrates Oy; 🇫🇮 Helsinki, Finland

HUS-Yhtymae

🇫🇮Helsinki, Finland

Katriina Jalkanen

Site contact

+358401440338

katriina.jalkanen@hus.fi