Melanoma Clinical Trial

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

Summary

To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors

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Full Description

This is an open-label, multicenter phase 1/2 study designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a monotherapy or in combination in subjects with metastatic or locally advanced solid tumors.

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Eligibility Criteria

Key Inclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

Subjects with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy.
Subjects with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy

Combination Therapy - Dose Expansion Part

Subjects with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded.
Subjects with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation.
Subjects with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting.
Subjects with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.

General (all phases):

Must be age ≥ 18 years of age on the day of signing informed consent, or the legal age of consent in the jurisdiction in which the trial is taking place.
Measurable disease according to RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) 0-1
Normal or adequate liver, renal, cardiac and bone marrow function

Key Exclusion Criteria:

Monotherapy - Dose Escalation and Dose Expansion Parts

Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration
Radiotherapy within 14 days prior to first GEN1042 administration
Toxicities from previous anti-cancer therapies that have not resolved

Combination Therapy - Dose Expansion Part

Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment.
Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of > 30 Gy within 6 months of the first dose of trial treatment.

General (all phases)

Subject has an active, known, or suspected autoimmune disease.
History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy
Subject with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

1287

Study ID:

NCT04083599

Recruitment Status:

Recruiting

Sponsor:

Genmab

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There are 24 Locations for this study

See Locations Near You

Alaska Oncology and Hematology LLC
Anchorage Alaska, 99508, United States
Cancer & Blood Specialty Clinic
Los Alamitos California, 90720, United States
Moores Cancer Center at the UC San Diego Health
San Diego California, 92037, United States
Yale University Cancer Center
New Haven Connecticut, 06520, United States
ChristianaCare
Newark Delaware, 19713, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Florida Cancer Affiliates
Ocala Florida, 34474, United States
Hope and Healing Cancer Services
Hinsdale Illinois, 60521, United States
University of Kentucky
Lexington Kentucky, 40536, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Maryland Oncology Hematology PA
Columbia Maryland, 21044, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Levine Cancer Center
Charlotte North Carolina, 28204, United States
Novant Health Cancer Institute - Forsyth (Medical Oncology)
Winston-Salem North Carolina, 27103, United States
Kaiser Permanente (KP) Oncology/Hematology
Portland Oregon, 97227, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Lumi Research
Kingwood Texas, 77339, United States
Utah Cancer Specialists
Salt Lake City Utah, 84124, United States
Virgina Cancer Specialists
Fairfax Virginia, 22031, United States
Adventist Health System/Sunbelt,Inc
Seattle Washington, 98109, United States
Medical Oncology Associates, PS
Spokane Washington, 99204, United States
Rigshospitalet (Copenhagen University Hospital)
Copenhagen , , Denmark
Herlev University Hospital
Herlev , , Denmark
University Hospital of Southern Denmark, Vejle Hospital
Vejle , , Denmark
Centre hospitalier Universitaire de Bordeaux
Bordeaux , , France
Centre Antoine Lacassagne
Nice , , France
Gustave Roussy
Villejuif , , France
ARENSIA Research Clinic at the Research Institute of Clinical Medicine
Tbilisi , , Georgia
Nationales Centrum fr Tumorerkrankungen NCT
Heidelberg , , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen , , Germany
Department of Dermatology, University of Mainz
Mainz , , Germany
Universitätsmedizin Mannheim Dermatologie
Mannheim , , Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , , Germany
Rabin Medical Center
Petah tikva , , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , , Israel
Azienda Ospedaliera Spedali Civili di Brescia
Brescia , , Italy
Azienda Ospedaliera S.Croce e Carle Cuneo
Cuneo , , Italy
Istituto Nazionale dei Tumori
Milan , , Italy
Istituto Clinico Humanitas
Rozzano , , Italy
Chungbuk National University Hospital
Cheongju-si , , Korea, Republic of
Jeonbuk National University Hospital
Jeonju , , Korea, Republic of
Gachon University Gil Medical Center
Namdong , , Korea, Republic of
Korea University Guro Hospital
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan , , Korea, Republic of
ARENSIA Research Clinic at the Oncology Institute
Chisinau , , Moldova, Republic of
H. Vall d'Hebron
Barcelona , , Spain
START Barcelona HM Nou Delfos
Barcelona , , Spain
Hospital Duran i Reynals - ICO L Hospitalet
L'Hospitalet De Llobregat , , Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas De Gran Canaria , 35016, Spain
Hospital Universitario Lucus Augusti
Lugo , , Spain
Clinica Universidad de Navarra
Madrid , , Spain
HM CIOCC Hospital Universitario HM Sanchinarro
Madrid , , Spain
Hospital Clinico San Carlos
Madrid , , Spain
Hospital General Universitario Gregorio Maran
Madrid , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario La Paz
Madrid , , Spain
Hospital Universitario Ramon y Cajal
Madrid , , Spain
MD Anderson Cancer Center Madrid
Madrid , , Spain
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Madrid , , Spain
Hospital Universitario Virgen de la Victoria
Málaga , , Spain
Clinica Universidad de Navarra
Pamplona , , Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago De Compostela , , Spain
Hospital Virgen del Rocio
Sevilla , , Spain
Hospital Clinico Universitario de Valencia
Valencia , , Spain
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Kaohsiung City , , Taiwan
Kaohsiung Medical University Memorial Hospital
Kaohsiung City , , Taiwan
China Medical University Hospital
Taichung , , Taiwan
National Cheng Kung University Hospital
Tainan , , Taiwan
Taipei Medical University Hospital
Taipei , , Taiwan
Taipei Veterans General Hospital, VGHTPE
Taipei , , Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan , , Taiwan
Royal Marsden NHS Foundation Trust
Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

1287

Study ID:

NCT04083599

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

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