TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TIL… (NCT06961786) | Clinical Trial Compass
Active — Not RecruitingPhase 1
TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma
Denmark9 participantsStarted 2025-06-25
Plain-language summary
This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
✓. Patients with pathologically confirmed previously treated refractory or recurrent stage 3-4 melanoma, which cannot be treated with curative intent with available therapies.
✓. Patients who have had at least 1 prior line of medical treatment (eg, checkpoint inhibitors, kinase inhibitors, IL-2). Multiple prior therapies (eg, surgery, checkpoint inhibitors, kinase inhibitors, IL-2, interferon, chemotherapy, radiation) are allowed.
✓. Patients must have a demonstrated WHO/ECOG performance score of 0-1 at screening.
✓. A tumor of \>9 mm 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 1 additional tumor (\>14 mm in diameter) must be available for injections and biopsies for correlative analyses. The disease burden must be evaluable according to RECIST 1.1.
✓. Patients must have adequate hepatic, cardiac, and renal function as follows:
✓. Platelets ≥ 100,000/µl and \< 700,000/µl
Exclusion criteria
✕. History of another active invasive cancer as judged by the investigator within the past 3 years except basal cell carcinoma.
✕. Uncontrolled cardiac or vascular diseases.
✕
What they're measuring
1
Number of Participants with any (serious and non-serious) Adverse Events
Timeframe: 78 days
2
Number of Participants with abnormal laboratory values
Timeframe: 78 days
3
Number of Participants with vital sign abnormalities
Timeframe: 78 days
4
Safety assessed by 12- lead electrocardiograms (ECGs) Adverse Events
. History of heart attack or cerebral stroke within the previous 12 months before screening or is not recovered from a previous heart attack or cerebral stroke.
✕. History of hepatic dysfunction, hepatitis, or human immunodeficiency virus.
✕. Patients should be seronegative for HIV antibody.
✕. Patients should be seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
✕. History of coagulation disorder.
✕. Untreated brain metastases. Treated brain metastases that have not progressed in the 3 months prior to screening are allowed.