DODEKA | PH- IL12L19L19-01/19

A Phase I Study to Evaluate Safety and Early Signs of Efficacy of the Human Monoclonal Antibody-cytokine Fusion Protein 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.

Klinische Settings

Indikation: Malignes Melanom

Therapiesituation: inoperable fortgeschritten, höhere Therapielinie

Einschlusskriterien

Male or Female aged 18 to 80 years at the time of consent.
Patients must have a histological or cytological diagnosis of advanced/metastatic immunotherapy responsive solid carcinoma for which immune checkpoint blockade is approved, that has progressed on immune checkpoint-blockade therapy.
Patients must have received an immune checkpoint blockade therapy-based regimen as prior treatment.
Only patients without other therapeutic alternatives with curative or survival prolonging potential per investigator judgement are able to participate.
Subjects must have had clinical benefit in terms of disease control (CR/PR/SD) while on checkpoint inhibitor treatment defined as ≥ 3 month free from progression from initial imaging documenting advanced/metastatic disease followed by radiographic disease progression after checkpoint inhibitor per investigator's opinion.
Patients must have progressive disease or relapse at the time of screening.
for more please visit clinicalTrial.gov

Ausschlusskriterien

Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start.
Radiotherapy within 4 weeks prior to study treatment start.
Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
Patients with primary brain tumors or CNS disease.
Patient taking herbal medications within 7 days prior to study treatment start.
Known history of allergy to an excipient in study medication or any other intravenously administered human proteins/peptides/antibodies.
for more please visit clinicalTrial.gov