OncoMatch/Clinical Trials/NCT04471987
Safety and Early Signs of Efficacy of IL12-L19L19.
Is NCT04471987 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT04471987 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug or device disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify