OncoMatch/Clinical Trials/NCT04471987
Safety and Early Signs of Efficacy of IL12-L19L19.
Is NCT04471987 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IL12-L19L19 and IL12-L19L19 for advanced solid tumor.
Treatment: IL12-L19L19 · IL12-L19L19 — The purpose of this study is to describe the safety, tolerability and early signs of efficacy of the antibody-cytokine fusion protein IL12-L19L19 in patients with advanced or metastatic solid carcinomas, after previous immune checkpoint blockade therapy. The primary objective of the study is to evaluate the safety of IL12-L19L19 and to establish MTD in order to establish a recommended dose (RD). The secondary objectives of the study are to assess early signs of efficacy, the determination of pharmacokinetic (PK) properties and the immunogenicity of IL12-L19L19.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage IV
Metastatic disease required
advanced/metastatic immunotherapy responsive solid carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: checkpoint inhibitor
Patients must have received an immune checkpoint blockade therapy-based regimen as prior treatment
Cannot have received: investigational drug or device
Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L, platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl excluded
Kidney function
creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN excluded
Liver function
ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN excluded; for patients with liver metastasis, ALT, AST, ALP and bilirubin ≥ 5 x ULN excluded
Cardiac function
Heart insufficiency (> Grade II, NYHA), clinically significant arrhythmias, abnormal LVEF, QTc >480 ms, history of risk factors for Torsades de Pointes, uncontrolled hypertension (SBP ≥ 140 mmHg and DBP ≥ 90 mmHg at 3 consecutive measurements), ischemic peripheral vascular disease (Grade IIb-IV), history within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
Absolute neutrophil count (ANC) < 1.5 x 10^9/L, platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl. Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). At the discretion of the investigator, an increased exclusion threshold for patients with liver metastasis can be accepted as follows: ALT, AST, ALP and bilirubin ≥ 5 x ULN. Heart insufficiency (> Grade II, NYHA), clinically significant arrhythmias, abnormal LVEF, QTc >480 ms, history of risk factors for Torsades de Pointes, uncontrolled hypertension (SBP ≥ 140 mmHg and DBP ≥ 90 mmHg at 3 consecutive measurements), ischemic peripheral vascular disease (Grade IIb-IV), history within the last year of cerebrovascular disease and/or acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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