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

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ClinicalTrials.gov Identifier: NCT04695327
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : April 12, 2023
Information provided by (Responsible Party):
TILT Biotherapeutics Ltd.

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: TILT-123 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 11, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 31, 2025

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

Primary Outcome Measures :
  1. Number of Participants with any (serious and non-serious) Adverse Events. [ Time Frame: 85 days ]
    Safety (I)

  2. Number of Participants with abnormal laboratory values. [ Time Frame: 85 days ]
    Safety (II)

  3. Number of Participants with vital sign abnormalities. [ Time Frame: 85 days ]
    Safety (III)

  4. Number of Participants with Adverse Events assessed by 12- lead electrocardiograms (ECGs) [ Time Frame: 85 days ]
    Safety (IV)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695327

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Contact: Docrates Cancer Center +358 107732050 hospital@docrates.com
Contact: Helsinki University Hospital +358 947173197

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Helsinki University Hospital Recruiting
Helsinki, Uusima, Finland, 00029
Contact: Katriina Peltola, MD, PhD         
Docrates Cancer Center Recruiting
Helsinki, Uusima, Finland, 00180
Contact: Tuomo Alanki, MD, PhD         
Sponsors and Collaborators
TILT Biotherapeutics Ltd.
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Principal Investigator: Katriina Peltola, MD, PhD Helsinki University Central Hospital
Principal Investigator: Tuomo Alanko, MD, PhD Docrates Cancer Center
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Responsible Party: TILT Biotherapeutics Ltd.
ClinicalTrials.gov Identifier: NCT04695327    
Other Study ID Numbers: TILT-T115
2020-001778-31 ( EudraCT Number )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: April 12, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TILT Biotherapeutics Ltd.:
Oncolytic virus
Additional relevant MeSH terms:
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Adenoviridae Infections
DNA Virus Infections
Virus Diseases