CompletedPhase 1

TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy

Finland32 participantsStarted 2021-01-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Platelets \> 75 000/mm3
. Haemoglobin ≥ 100 g/L.
. AST and ALT \< 3 x ULN.
. GFR \>60 ml/min (Cockcroft-Gault formula).
. Leukocytes (WBC) \> 3,0
. 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:
. 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).
. Women not of childbearing potential: Barrier contraceptive method (i.e. condom) must be used.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with any (serious and non-serious) Adverse Events.

Timeframe: 85 days

Number of Participants with abnormal laboratory values.

Timeframe: 85 days

Number of Participants with vital sign abnormalities.

Timeframe: 85 days

Number of Participants with Adverse Events assessed by 12- lead electrocardiograms (ECGs)

Timeframe: 85 days

Trial details

NCT IDNCT04695327

SponsorTILT Biotherapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-03

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Platelets \> 75 000/mm3
. Haemoglobin ≥ 100 g/L.
. AST and ALT \< 3 x ULN.
. GFR \>60 ml/min (Cockcroft-Gault formula).
. Leukocytes (WBC) \> 3,0
. 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:
. 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).
. Women not of childbearing potential: Barrier contraceptive method (i.e. condom) must be used.

What they're measuring

Number of Participants with any (serious and non-serious) Adverse Events.

Timeframe: 85 days

Number of Participants with abnormal laboratory values.

Timeframe: 85 days

Number of Participants with vital sign abnormalities.

Timeframe: 85 days

Number of Participants with Adverse Events assessed by 12- lead electrocardiograms (ECGs)

Timeframe: 85 days