Spots Global Cancer Trial Database for Safety and Early Signs of Efficacy of IL12-L19L19.
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Trial Identification
Brief Title: Safety and Early Signs of Efficacy of IL12-L19L19.
Official Title: A Phase I Study to Evaluate Safety and Early Signs of Efficacy of the Human Monoclonal Antibody-cytokine Fusion Protein IL12-L19L19.
Study ID: NCT04471987
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Universitaetsklinik Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinikum Heidelberg, Nationalen Centrum fßr Tumorerkrankungen (NCT), Dermatoonkologie, Heidelberg, , Germany
Universitätsklinikum Leipzig, Klinik fßr Dermatologie, Venerologie und Allergologie, Leipzig, , Germany
Universitätsklinikum Tßbingen, Klinik fßr Innere Medizin VIII Medizinische Onkologie und Pneumologie, Tßbingen, , Germany
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
IEO - Istituto Europeo di Oncologia, Milan, , Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, , Italy
Universitätsspital Basel, Basel, , Switzerland
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Geneva University Hospital, Oncology Department, Geneva, , Switzerland
Contact Details
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