Trial Title:
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
NCT ID:
NCT04083599
Condition:
Malignant Solid Tumor
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Melanoma
Head and Neck Squamous Cell Carcinoma (HNSCC)
Pancreatic Ductal Adenocarcinoma (PDAC)
Conditions: Official terms:
Neoplasms
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Gemcitabine
Pembrolizumab
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GEN1042
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Arm group label:
Monotherapy - Dose Escalation and Dose Expansion Parts
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
5-FU
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Intravenous
Arm group label:
Combination Therapy - Safety Run-in and Expansion Parts
Summary:
The goal of this trial is to learn about the antibody GEN1042 when it is used alone and
when it is used together with another antibody cancer drug, pembrolizumab (with or
without chemotherapy), for treatment of participants with certain types of cancer.
Detailed 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 participants with metastatic or locally advanced solid
tumors.
Participants will receive either GEN1042 alone, GEN1042 with pembrolizumab, or GEN1042
with pembrolizumab and chemotherapy. All participants will receive active drug; no one
will receive placebo.
This trial has 2 parts. The purpose of the first part is to find out if GEN1042 is safe
and to find out the best doses of GEN1042 to use. The purpose of the second part is to
give GEN1042 to more participants to see how well the dose(s) of GEN1042 selected in the
first part work against cancer with GEN1042 when given alone or in combination with
pembrolizumab or in combination with pembrolizumab and chemotherapy.
Trial details include:
- The average trial duration will be about 3 years.
- The treatment duration will be up to 2 years (when GEN1042 is combined with
pembrolizumab).
- The visit frequency will be weekly at first and lessening over time until visits are
only once every 3 weeks.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
Monotherapy - Dose Escalation and Dose Expansion Parts
- Participants with non-CNS solid tumors that is metastatic or unresectable and for
whom there is no available standard therapy.
- Participants 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
- Participants 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.
- Participants with Stage IV metastatic or recurrent NSCLC with no prior systemic
anticancer therapy, no actionable mutation.
- Participants with recurrent or metastatic HNSCC with no prior systemic therapy
administered in the recurrent or metastatic setting.
- Participants 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)
- Participants 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
- Participants 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alaska Oncology and Hematology LLC
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer & Blood Specialty Clinic
Address:
City:
Los Alamitos
Zip:
90720
Country:
United States
Status:
Recruiting
Facility:
Name:
Moores Cancer Center at the UC San Diego Health
Address:
City:
San Diego
Zip:
92037
Country:
United States
Status:
Completed
Facility:
Name:
Yale University Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
ChristianaCare
Address:
City:
Newark
Zip:
19713
Country:
United States
Status:
Recruiting
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Affiliates
Address:
City:
Ocala
Zip:
34474
Country:
United States
Status:
Recruiting
Facility:
Name:
Hope and Healing Cancer Services
Address:
City:
Hinsdale
Zip:
60521
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Maryland Oncology Hematology PA
Address:
City:
Columbia
Zip:
21044
Country:
United States
Status:
Completed
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Levine Cancer Center
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
Novant Health Cancer Institute - Forsyth (Medical Oncology)
Address:
City:
Winston-Salem
Zip:
27103
Country:
United States
Status:
Recruiting
Facility:
Name:
Kaiser Permanente (KP) Oncology/Hematology
Address:
City:
Portland
Zip:
97227
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Lumi Research
Address:
City:
Kingwood
Zip:
77339
Country:
United States
Status:
Recruiting
Facility:
Name:
Utah Cancer Specialists
Address:
City:
Salt Lake City
Zip:
84124
Country:
United States
Status:
Completed
Facility:
Name:
Virgina Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Adventist Health System/Sunbelt,Inc
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical Oncology Associates, PS
Address:
City:
Spokane
Zip:
99204
Country:
United States
Status:
Completed
Facility:
Name:
Rigshospitalet (Copenhagen University Hospital)
Address:
City:
Copenhagen
Country:
Denmark
Status:
Completed
Facility:
Name:
Herlev University Hospital
Address:
City:
Herlev
Country:
Denmark
Status:
Completed
Facility:
Name:
University Hospital of Southern Denmark, Vejle Hospital
Address:
City:
Vejle
Country:
Denmark
Status:
Completed
Facility:
Name:
Centre hospitalier Universitaire de Bordeaux
Address:
City:
Bordeaux
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Recruiting
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Facility:
Name:
ARENSIA Research Clinic at the Research Institute of Clinical Medicine
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Nationales Centrum fr Tumorerkrankungen NCT
Address:
City:
Heidelberg
Country:
Germany
Status:
Completed
Facility:
Name:
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Address:
City:
Ludwigshafen
Country:
Germany
Status:
Completed
Facility:
Name:
Department of Dermatology, University of Mainz
Address:
City:
Mainz
Country:
Germany
Status:
Completed
Facility:
Name:
Universitätsmedizin Mannheim Dermatologie
Address:
City:
Mannheim
Country:
Germany
Status:
Completed
Facility:
Name:
Universitaetsklinikum Wuerzburg
Address:
City:
Wuerzburg
Country:
Germany
Status:
Completed
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah tikva
Country:
Israel
Status:
Completed
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Country:
Israel
Status:
Completed
Facility:
Name:
Azienda Ospedaliera Spedali Civili di Brescia
Address:
City:
Brescia
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera S.Croce e Carle Cuneo
Address:
City:
Cuneo
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Nazionale dei Tumori
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju-si
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Jeonbuk National University Hospital
Address:
City:
Jeonju
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Namdong
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pusan National University Yangsan Hospital
Address:
City:
Yangsan
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
ARENSIA Research Clinic at the Oncology Institute
Address:
City:
Chisinau
Country:
Moldova, Republic of
Status:
Recruiting
Facility:
Name:
H. Vall d'Hebron
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Barcelona HM Nou Delfos
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Duran i Reynals - ICO L Hospitalet
Address:
City:
L'Hospitalet De Llobregat
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Insular de Gran Canaria
Address:
City:
Las Palmas De Gran Canaria
Zip:
35016
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Lucus Augusti
Address:
City:
Lugo
Country:
Spain
Status:
Completed
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
HM CIOCC Hospital Universitario HM Sanchinarro
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico San Carlos
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Maran
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario La Paz
Address:
City:
Madrid
Country:
Spain
Status:
Completed
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
MD Anderson Cancer Center Madrid
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de la Victoria
Address:
City:
Málaga
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Complejo Hospitalario Universitario de Santiago (CHUS)
Address:
City:
Santiago De Compostela
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Virgen del Rocio
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
Address:
City:
Kaohsiung City
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University Memorial Hospital
Address:
City:
Kaohsiung City
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Medical University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital, VGHTPE
Address:
City:
Taipei
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Memorial Hospital Linkou Branch
Address:
City:
Taoyuan
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Royal Marsden NHS Foundation Trust
Address:
City:
Sutton
Country:
United Kingdom
Status:
Completed
Start date:
September 17, 2019
Completion date:
September 2025
Lead sponsor:
Agency:
Genmab
Agency class:
Industry
Collaborator:
Agency:
BioNTech SE
Agency class:
Industry
Source:
Genmab
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04083599
