Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung … (NCT06125197) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer
United States22 participantsStarted 2024-07-23
Plain-language summary
This is an open label, Phase 1, dose escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab in patients with immune checkpoint inhibitor refractory non-small cell lung cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Histologically confirmed NSCLC cancer which cannot be treated with curative intent with available therapies and is refractory to or progressing after anti-PD(L)1 immunotherapy or immunotherapies.
At least one tumor lesion (\>15 mm or bigger) must be available for biopsy that in the opinion of the investigator, is accessible to repeated biopsies without major safety concerns.
The patient must have disease evaluable per RECIST 1.1
Have adequate organ function as defined in the following values below. Specimens must be collected within 10 days prior to the start of study treatment.
Hematological laboratory values
* Absolute neutrophil count (ANC): ≥1500/µL
* Platelets: ≥ 100 000/µL
* Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L. Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin (≥ approximately 3 months.
* Leukocytes (WBC) \> 3.0
Renal laboratory values
* GFR: \>45 ml/min (Cockcroft-Gault formula).
* Hepatic laboratory values
* Total bilirubin: ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN (excluding patients with Gilbert's disease)
* AST (SGOT) and ALT (SGPT): ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
Patients must be willing to use adequate forms of contraception from screening, during the trial, and for a minimum of 120 days after end of treatment.
ECOG/WHO performance score of 0-1 at screenin…