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COMPLETEDPHASE1

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

A Phase 1, Open-Label, Dose-Escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 in Melanoma Patients Receiving Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes

NCT04217473•TILT Biotherapeutics Ltd.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

The primary objective of the trial is to evaluate the safety of TILT-123. The approach has the potential to a) increase the efficacy of adoptive T-cell therapy, b) remove the need for toxic pre- and post-conditioning regimens, c) yield the combined anti-tumor benefits of armed oncolytic viruses and T-cell therapy. Dose escalation of TILT-123 injection will take place between cohorts not intra-patient and will be determined based on Dose Limiting Toxicities (DLTs).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed and dated informed consent before any trial-related activities.
•Male or female, between 18-75 years of age (both included).
•Pathologically confirmed previously treated refractory or recurrent stage 3-4 melanoma, which cannot be treated with curative intent with available therapies.
•At least one prior line of medical treatment is required (for example checkpoint inhibitors, kinase inhibitors, interleukin-2). Multiple prior therapies (e.g. surgery, checkpoint inhibitors, kinase inhibitors, interleukin-2, interferon, chemotherapy, radiation) are allowed.
•A \> 9 mm tumor (in diameter, typically a minimum of 1 cm3 in volume) without signs of necrosis must be available for biopsy/operation to enable growing of TILs.
•At least one additional tumor (\>14 mm in diameter) must be available for injections and biopsies for correlative analyses. The disease burden must be measurable, but does not need to fulfil RECIST 1.1.
•Eligible for adoptive T-cell therapy with tumor infiltrating lymphocytes
•Adequate hepatic, cardiac and renal functions as following:
•1. Platelets \> 75 000/mm3
•2. Haemoglobin ≥ 100 g/L.
+12 more criteria

Exclusion Criteria

•Use of immunosuppressive medications (corticosteroids or drugs used in treatment of autoimmune disease). Exempted are the following which can be allowed at screening and during the trial: replacement corticosteroids if e.g. the patient has adrenal insufficiency after prior immunotherapy; pulmonal and topical treatments; up to 20 mg of prednisone/prednisolone.
•History of another active invasive cancer as judged by the investigator within the past 3 years except basalioma.
•Treated with any anti-cancer therapy for melanoma 30 days prior to enrolment. Anti-cancer therapy for melanoma is defined as anti-cancer agents (immunotherapy, signal-transduction inhibitors \[e.g. BRAF and MEK inhibitors\], cytotoxic chemotherapy), radiotherapy and investigational agents. An investigational agent is any drug or therapy that is currently not approved for use in humans.
•Uncontrolled cardiac or vascular diseases.
•History of heart attack or cerebral stroke within the previous 12 months before screening or is not recovered from an older heart attack or cerebral stroke.
•LDH value \> 3 x ULN.
•History of hepatic dysfunction, hepatitis or HIV.
•History of coagulation disorder.
•Any other disease which prevent participation in the opinion of the investigator.
•Female patients who are pregnant, breastfeeding or intends to become pregnant.
+5 more criteria

Locations (2)

National Center for Cancer Immune Therapy Herlev Hospital, Copenhagen University

Copenhagen, Denmark

CHU Nantes

Nantes, France

Key Dates

Start Date

February 26, 2020

Primary Completion Date

December 12, 2023

Completion Date

July 23, 2024

Last Updated

August 7, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

TILT-123

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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