GEN1046 Safety Trial in Patients With Malignant Solid Tumors

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

429

Participants

Timeline

Start Date

May 14, 2019

Primary Completion Date

April 1, 2025

Study Completion Date

February 28, 2026

Conditions
Solid TumorsNon-small Cell Lung CancerUrothelial CarcinomaEndometrial CarcinomaTriple Negative Breast CancerSquamous Cell Carcinoma of the Head and NeckCervical Cancer
Interventions
BIOLOGICAL

Acasunlimab

Acasunlimab will be administered intravenously once every 21 days (in selected expansion cohorts acasunlimab will be administered intravenously once every 21 days for the first 2 cycles, and every 42 days in subsequent cycles).

BIOLOGICAL

Acasunlimab in combination with docetaxel (in a single expansion cohort)

Acasunlimab and docetaxel will be administered intravenously once every 21 days.

BIOLOGICAL

Acasunlimab in combination with pembrolizumab (in a separate expansion cohort)

Acasunlimab and pembrolizumab will be administered intravenously once every 21 days or every 42 days, respectively.

BIOLOGICAL

Acasunlimab in combination with pembrolizumab and standard chemotherapy (in separate expansion cohorts)

Acasunlimab and pembrolizumab and standard chemotherapy will be administered intravenously once every 21 days for 4 cycles, followed by treatment with acasunlimab and pembrolizumab once every 21 days.

Trial Locations (57)

8023

IOB-Hospital Quironsalud Barcelona, Barcelona

10016

NYU Langone, New York

12000

Hadassah Medical Organization HMO - Sharett Institute of Oncology, Jerusalem

27514

UNC Chapel Hill, Chapel Hill

28040

START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

START Madrid-CIOCC, Madrid

28204

Levine Cancer Institute, Atrium Health, Charlotte

28223

NEXT Oncology Madrid, Madrid

30322

Emory University, Atlanta

31008

Clinica Universidad de Navarra, Pamplona

32224

Mayo Clinic, Jacksonville

40202

Norton Healthcare Inc, Louisville

44106

University Hospitals Cleveland Medical Center, Cleveland

46010

Hospital Clinico De Valencia, Valencia

48109

University of Michigan, Ann Arbor

49546

START Midwest, Grand Rapids

52242

University of Iowa Hospitals, Iowa City

52621

Sheba Medical Center, Ramat Gan, Tel Litwinsky

55905

Mayo Clinic, Rochester

63110

Washington University School of Medicine, St Louis

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

85054

Mayo Clinic, Phoenix

06520-8028

Yale University Cancer Center, New Haven

Unknown

Fakultni nemocnice Brno, Brno

University Hospital Brno, Brno

Nemocnice AGEL Ostrava-Vítkovice a.s., Nový Jičín

Fakultni nemocnice Olomouc, Olomouc

High Technology Hospital Medcenter, Batumi

"LLC TIM - Tbilisi Institute of Medicine", Tbilisi

LTD Consilium Medulla, Tbilisi

Tbilisi State Medical University and Ingorovka High Medical Technology University Clinic Ltd, Tbilisi

Onkologiai Klinika, Debrecen

BKMK Hospital, Kecskemét

Pulmonology Hospital Törökbálinti, Törökbálint

Rambam Health Care Campus RHCC - Rambam Medical Center, Haifa

Policlinico San'Orsola, Bologna

IRCCS - Istituto Europeo di Oncologia IEO, Milan

Istituto Nazionale Tumori - Fondazione Pascale Italy, Napoli

Azienda Ospedaliero Universitaria di Parma, Parma

AUSL Romagno-Ravenna, Ravenna

Policlinico Uni. Campus Bio-Medico, Roma

Regina Elena National Cancer Institute, Rome

"ASST Sette Laghi Ospedale di Circolo e Fondazione Macchi ", Varese

Uniwersyteckie Centrum Kliniczne, Gdansk

Medpolonia Sp. z o.o., Poznan

Specialist Hospital in Prabuty, Prabuty

Dom Lekarski SA, Szczecin

Maria Sklodowska Curie National Research Instutute of Oncology, Warsaw

Hospital Universitario La Princesa, Madrid

MD Anderson Cancer Center Madrid, Madrid

Hospital Universitario Virgen de la Victoria, Málaga

Gulhane Training and Research Hospital, Ankara

Trakya University Hospital, Edirne

Medical Point Izmir Hospital, Karşıyaka

ARENSIA Exploratory Medicine LLC, Kyiv

08035

Hospital Universitario Vall dHebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genmab

INDUSTRY