TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy (TUNIMO)

March 4, 2026 updated by: TILT Biotherapeutics Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Uusima
      • Helsinki, Uusima, Finland, 00029
        • Helsinki University Hospital
      • Helsinki, Uusima, Finland, 00180
        • Docrates Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed and dated informed consent before any trial-related activities.
  • Male or female over 18 years of age
  • Pathologically confirmed refractory or recurrent injectable solid tumor, which cannot be treated with curative intent with available therapies.
  • Standard therapy has failed, it does not exist, is not available or is unlikely to result in meaningful clinical benefit (as assessed by the investigator). Other appropriate evidence-based therapies have failed or are contraindicated.
  • Multiple prior therapies (e.g. surgery, chemotherapy, checkpoint inhibitors, kinase inhibitors, biological therapies, hormonal therapies, radiation, etc) are allowed.
  • At least one 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.

  • Adequate hepatic and renal functions as following:

    1. Platelets > 75 000/mm3
    2. Haemoglobin ≥ 100 g/L.
    3. AST and ALT < 3 x ULN.
    4. GFR >60 ml/min (Cockcroft-Gault formula).
    5. Leukocytes (WBC) > 3,0
    6. Bilirubin <1,5 x ULN 8. Men and women must be willing to use adequate forms of contraception from screening, during the trial, and for a minimum of 90 days after end of treatment, in accordance with the following:
    1. Women of childbearing potential: Barrier contraceptive method (i.e. condom) must be used in addition to one of the following methods: Intrauterine device or hormonal contraception (oral contraceptive pills, implant, transdermal patches, vaginal ring or long-acting injections).
    2. Women not of childbearing potential: Barrier contraceptive method (i.e. condom) must be used.
    3. Men: Barrier contraceptive method (i.e. condom) must be used.
  • Demonstrated WHO/ECOG performance score of 0-1 at screening.
  • Life expectancy time longer than 3 months.
  • Capable of understanding and complying with parameters as outlined in the protocol.

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: a) replacement corticosteroids if e.g. the patient has adrenal insufficiency after prior immunotherapy b) inhaled and topical treatments c) up to 20 mg per day of prednisone/prednisolone.
  • Treated with any anti-cancer therapy within 30 days prior to the first virus injection. Anti-cancer therapy is defined as anti-cancer agents (e.g. cytotoxic chemotherapy, immunotherapy, signal-transduction inhibitors, etc) and investigational agents. An investigational agent is any drug or therapy that is currently not approved for use in humans. Continuation of hormonal therapy or use of bone modifying agents (eg. bisphosphonate or denosumab) is allowed if started at least 3 months before. Palliative radiation is not allowed within 14 days of the first virus injection (before or after), but it is allowed after day 15 during the trial treatment period, if deemed necessary by the investigator.
  • Uncontrolled cardiac or vascular diseases.
  • History of myocardial infarction or cerebral stroke within the previous 12 months before screening or is not sufficiently recovered from an older infarction or cerebral stroke.
  • History of severe hepatic dysfunction, hepatitis or HIV.
  • History of coagulation disorder.
  • Any other medical condition or laboratory abnormality that in the judgment of the principal investigator, may increase the risk associated with study participation or may interfere with interpretation of study results and /or otherwise make the patient inappropriate for entry into this trial.
  • Female patients who are pregnant, breastfeeding or intend to become pregnant.
  • Untreated brain metastases. Treated brain metastases which have not progressed in 3 months prior to screening are allowed.
  • Previously treated (within 5 years) with any oncolytic or replication deficient adenovirus.
  • Allergy to ingredients present in the investigational medicinal products (ingredients are listed in the protocol).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy

Patients will receive multiple administrations of TILT-123.

Escalation to the next dose of TILT-123 level will occur when the safety data has been evaluated for all patients in the preceding dose level.
Biological: TILT-123
TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
Other Names:
  • TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
  • Ad5/3-E2F-d24-hTNFa-IRES-hIL2

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TILT Biotherapeutics Ltd.

Investigators

  • Principal Investigator: Katriina Peltola, MD, PhD, Helsinki University Central Hospital
  • Principal Investigator: Tuomo Alanko, MD, PhD, Docrates Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Actual)

September 3, 2025

Study Completion (Actual)

September 3, 2025

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TILT-T115
  • 2020-001778-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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