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 range18 Years

SexALL

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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

Trial details

NCT IDNCT04695327

SponsorTILT Biotherapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-03

View on ClinicalTrials.gov More Solid Tumor trials