Spots Global Cancer Trial Database for GEN1046 Safety Trial in Patients With Malignant Solid Tumors
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Trial Identification
Brief Title: GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Official Title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors
Study ID: NCT03917381
Study Description
Brief Summary: The purpose of the trial is to evaluate the safety of acasunlimab (also known as GEN1046) as monotherapy and in combination therapies in patients with malignant solid tumors
Detailed Description: The trial is an open-label, multi-center safety trial of acasunlimab (GEN1046). The trial consists of two parts, a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a)). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
Yale University Cancer Center, New Haven, Connecticut, United States
Mayo Clinic, Jacksonville, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Iowa Hospitals, Iowa City, Iowa, United States
Norton Healthcare Inc, Louisville, Kentucky, United States
University of Michigan, Ann Arbor, Michigan, United States
START Midwest, Grand Rapids, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
NYU Langone, New York, New York, United States
UNC Chapel Hill, Chapel Hill, North Carolina, United States
Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Fakultni nemocnice Brno, Brno, , Czechia
University Hospital Brno, Brno, , Czechia
Nemocnice AGEL Ostrava-Vítkovice a.s., Nový Jičín, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
High Technology Hospital Medcenter, Batumi, , Georgia
LLC "TIM - Tbilisi Institute of Medicine", Tbilisi, , Georgia
LTD Consilium Medulla, Tbilisi, , Georgia
Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd, Tbilisi, , Georgia
Onkologiai Klinika, Debrecen, , Hungary
BKMK Hospital, Kecskemét, , Hungary
Pulmonology Hospital Törökbálinti, Törökbálint, , Hungary
Rambam Health Care Campus RHCC - Rambam Medical Center, Haifa, , Israel
Hadassah Medical Organization HMO - Sharett Institute of Oncology, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Sheba Medical Center, Ramat Gan, Tel HaShomer, , Israel
Policlinico San'Orsola, Bologna, , Italy
IRCCS - Istituto Europeo di Oncologia IEO, Milan, , Italy
Istituto Nazionale Tumori - Fondazione Pascale Italy, Napoli, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
AUSL Romagno-Ravenna, Ravenna, , Italy
Policlinico Uni. Campus Bio-Medico, Roma, , Italy
Regina Elena National Cancer Institute, Rome, , Italy
ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi ", Varese, , Italy
Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland
Medpolonia Sp. z o.o., Poznań, , Poland
Specialist Hospital in Prabuty, Prabuty, , Poland
Dom Lekarski SA, Szczecin, , Poland
Maria Sklodowska Curie National Research Instutute of Oncology, Warsaw, , Poland
Hospital Universitario Vall dHebron, Barcelona, , Spain
IOB-Hospital Quironsalud Barcelona, Barcelona, , Spain
START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
START Madrid-CIOCC, Madrid, , Spain
NEXT Oncology Madrid, Madrid, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Hospital Clinico De Valencia, Valencia, , Spain
Gulhane Training and Research Hospital, Ankara, , Turkey
Trakya University Hospital, Edirne, , Turkey
Medical Point Izmir Hospital, Karsiyaka, , Turkey
ARENSIA Exploratory Medicine LLC, Kyiv, , Ukraine
Contact Details
Name: Study Official
Affiliation: Genmab
Role: STUDY_DIRECTOR
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