Safety and Early Signs of Efficacy of IL12-L19L19.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPhilogen S.p.A.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 (including brain metastases).
Trial design
Treatments tested in this trial
- IL12-L19L19
- IL12-L19L19
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov