NCT04217473 (TUNINTIL) is a Phase 1 clinical trial of TILT-123 in Metastatic Melanoma, sponsored by TILT Biotherapeutics Ltd..

Who is sponsoring NCT04217473?

NCT04217473 is sponsored by TILT Biotherapeutics Ltd..

What drugs are being tested in NCT04217473?

Interventions in NCT04217473: TILT-123.

What condition does NCT04217473 study?

NCT04217473 studies Metastatic Melanoma.

Is NCT04217473 still recruiting?

NCT04217473 is currently completed. Last updated 7 August 2025.

Last reviewed 2025-08-07 · How we verify

NCT04217473: TUNINTIL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

TNFalpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 During TIL Treatment of Advanced Melanoma

Completed Phase 1 Last updated 7 August 2025

What this trial tests

Phase 1 trial testing TILT-123 in Metastatic Melanoma in 17 participants. Completed in 23 July 2024.

Timeline

26 February 2020

Primary endpoint
12 December 2023

23 July 2024

Quick facts

Lead sponsor	TILT Biotherapeutics Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	26 February 2020
Primary completion	12 December 2023
Estimated completion	23 July 2024
Sites	2 locations across Denmark, France

Drugs / interventions tested

TILT-123 — full drug profile →

Conditions studied

Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

TILT Biotherapeutics Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, phase 1, first-in-human (FIH), dose-escalation, multicenter, multinational trial evaluating the safety of oncolytic adenovirus TILT-123 as monotherapy and in association with T-cell therapy with TILs in metastatic melanoma patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Oncolytic viruses for cancer immunotherapy.
Hemminki O, Dos Santos JM, Hemminki A. · · 2020 · cited 246× · PMID 32600470 · DOI 10.1186/s13045-020-00922-1
Engineering strategies to enhance oncolytic viruses in cancer immunotherapy.
Tian Y, Xie D, Yang L. · · 2022 · cited 199× · PMID 35387984 · DOI 10.1038/s41392-022-00951-x
Inflammatory Cytokines in Cancer: Comprehensive Understanding and Clinical Progress in Gene Therapy.
Lan T, Chen L, Wei X. · · 2021 · cited 160× · PMID 33429846 · DOI 10.3390/cells10010100
A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539
Oncolytic Viruses: Newest Frontier for Cancer Immunotherapy.
Rahman MM, McFadden G. · · 2021 · cited 107× · PMID 34771615 · DOI 10.3390/cancers13215452
Tumor-Infiltrating Lymphocyte Therapy in Melanoma: Facts to the Future.
Betof Warner A, Corrie PG, Hamid O. · · 2023 · cited 81× · PMID 36485001 · DOI 10.1158/1078-0432.ccr-22-1922
Oncolytic viruses encoding bispecific T cell engagers: a blueprint for emerging immunovirotherapies.
Heidbuechel JPW, Engeland CE. · · 2021 · cited 80× · PMID 33863363 · DOI 10.1186/s13045-021-01075-5
Concepts in Oncolytic Adenovirus Therapy.
Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522

Verify or expand the search:

Other trials of TILT-123

Trials testing the same drug.

NCT06125197 — Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer · Phase 1 · active not recruiting
NCT04695327 — TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy · Phase 1 · completed

Other recruiting trials for Metastatic Melanoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07237100 — Mirdametinib in Patients With Advanced NF1-mutant Melanoma · Phase 2 · recruiting
NCT07086105 — A Study to Evaluate Adze1.C in Participants With Metastatic Melanoma · Phase 1 · recruiting
NCT07112170 — Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Melanoma · NA · recruiting
NCT06488365 — In Vivo Liquid Biopsy of Melanoma (Cytophone) · NA · recruiting

Other TILT Biotherapeutics Ltd. trials

Trials by the same sponsor.

NCT06125197 — Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer · Phase 1 · active not recruiting
NCT04695327 — TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04217473 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by TILT Biotherapeutics Ltd.
Last refreshed: 7 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04217473.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing