GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

September 17, 2019

Primary Completion Date

December 31, 2025

Study Completion Date

November 30, 2026

Conditions
Malignant Solid TumorNon-Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)MelanomaHead and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic Ductal Adenocarcinoma (PDAC)
Interventions
BIOLOGICAL

GEN1042

Intravenous

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

5-FU

Intravenous

DRUG

Gemcitabine

Intravenous

DRUG

Nab paclitaxel

Intravenous

DRUG

Pemetrexed

Intravenous

DRUG

Paclitaxel

Intravenous

Trial Locations (76)

19104

University of Pennsylvania, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

19713

ChristianaCare, Newark

21044

Maryland Oncology Hematology PA, Columbia

22031

Virgina Cancer Specialists, Fairfax

27103

Novant Health Cancer Institute - Forsyth (Medical Oncology), Winston-Salem

28204

Levine Cancer Center, Charlotte

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

34474

Florida Cancer Affiliates, Ocala

35016

Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria

37203

Sarah Cannon Research Institute, Nashville

40202

Norton Cancer Institute, Louisville

40536

University of Kentucky, Lexington

60521

Hope and Healing Cancer Services, Hinsdale

63110

Washington University School of Medicine, St Louis

77339

Lumi Research, Kingwood

84124

Utah Cancer Specialists, Salt Lake City

90720

Cancer & Blood Specialty Clinic, Los Alamitos

92037

Moores Cancer Center at the UC San Diego Health, San Diego

97227

Kaiser Permanente (KP) Oncology/Hematology, Portland

98109

Adventist Health System/Sunbelt,Inc, Seattle

99204

Medical Oncology Associates, PS, Spokane

99508

Alaska Oncology and Hematology LLC, Anchorage

06520

Yale University Cancer Center, New Haven

Unknown

Rigshospitalet (Copenhagen University Hospital), Copenhagen

Herlev University Hospital, Herlev

University Hospital of Southern Denmark, Vejle Hospital, Vejle

Centre hospitalier Universitaire de Bordeaux, Bordeaux

Centre Antoine Lacassagne, Nice

Gustave Roussy, Villejuif

ARENSIA Research Clinic at the Research Institute of Clinical Medicine, Tbilisi

Nationales Centrum fr Tumorerkrankungen NCT, Heidelberg

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen

Department of Dermatology, University of Mainz, Mainz

Universitätsmedizin Mannheim Dermatologie, Mannheim

Universitaetsklinikum Wuerzburg, Würzburg

Rabin Medical Center, Petah Tikva

Tel Aviv Sourasky Medical Center, Tel Aviv

Azienda Ospedaliera Spedali Civili di Brescia, Brescia

Azienda Ospedaliera S.Croce e Carle Cuneo, Cuneo

Istituto Nazionale dei Tumori, Milan

Istituto Clinico Humanitas, Rozzano

ARENSIA Research Clinic at the Oncology Institute, Chisinau

Chungbuk National University Hospital, Cheongju-si

Jeonbuk National University Hospital, Jeonju

Gachon University Gil Medical Center, Namdong

Korea University Guro Hospital, Seoul

Samsung Medical Center, Seoul

Severance Hospital, Yonsei University Health System, Seoul

Pusan National University Yangsan Hospital, Yangsan

H. Vall d'Hebron, Barcelona

START Barcelona HM Nou Delfos, Barcelona

Hospital Duran i Reynals - ICO L Hospitalet, L'Hospitalet de Llobregat

Hospital Universitario Lucus Augusti, Lugo

Clinica Universidad de Navarra, Madrid

HM CIOCC Hospital Universitario HM Sanchinarro, Madrid

Hospital Clinico San Carlos, Madrid

Hospital General Universitario Gregorio Maran, Madrid

Hospital Universitario 12 de Octubre, Madrid

Hospital Universitario La Paz, Madrid

Hospital Universitario Ramon y Cajal, Madrid

MD Anderson Cancer Center Madrid, Madrid

START Madrid - Hospital Universitario Fundacion Jimenez Diaz, Madrid

Hospital Universitario Virgen de la Victoria, Málaga

Clinica Universidad de Navarra, Pamplona

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

Hospital Virgen del Rocio, Seville

Hospital Clinico Universitario de Valencia, Valencia

Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch, Kaohsiung City

Kaohsiung Medical University Memorial Hospital, Kaohsiung City

China Medical University Hospital, Taichung

National Cheng Kung University Hospital, Tainan City

Taipei Medical University Hospital, Taipei

Taipei Veterans General Hospital, VGHTPE, Taipei

Chang Gung Memorial Hospital Linkou Branch, Taoyuan District

Royal Marsden NHS Foundation Trust, Sutton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

BioNTech SE

INDUSTRY

lead

Genmab

INDUSTRY