Back to resultsGEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
Primary Purpose
Malignant Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GEN1042
Pembrolizumab
Cisplatin
Carboplatin
5-FU
Gemcitabine
Nab paclitaxel
Pemetrexed
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Solid Tumor
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 and tumor demonstrating PD-L1 IHC CPS ≥1.
- 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
- 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.
Sites / Locations
- Alaska Oncology and Hematology LLCRecruiting
- Cancer & Blood Specialty ClinicRecruiting
- Moores Cancer Center at the UC San Diego HealthRecruiting
- Yale University Cancer CenterRecruiting
- ChristianaCareRecruiting
- Mount Sinai Comprehensive Cancer Center
- Florida Cancer AffiliatesRecruiting
- University of Kentucky
- Norton Cancer InstituteRecruiting
- University of Maryland Greenebaum Comprehensive Cancer Center
- Maryland Oncology Hematology PARecruiting
- Washington University School of MedicineRecruiting
- Levine Cancer CenterRecruiting
- Novant Health Cancer Institute - Forsyth (Medical Oncology)Recruiting
- Kaiser Permanente (KP) Oncology/HematologyRecruiting
- University of PennsylvaniaRecruiting
- Fox Chase Cancer CenterRecruiting
- Sarah Cannon Research InstituteRecruiting
- Lumi ResearchRecruiting
- Utah Cancer SpecialistsRecruiting
- Virgina Cancer SpecialistsRecruiting
- Adventist Health System/Sunbelt,Inc
- Medical Oncology Associates, PSRecruiting
- Central Washington Health Services Association
- Rigshospitalet (Copenhagen University Hospital)
- Herlev University HospitalRecruiting
- University Hospital of Southern Denmark, Vejle HospitalRecruiting
- Centre hospitalier Universitaire de BordeauxRecruiting
- Centre Antoine Lacassagne
- Gustave RoussyRecruiting
- ARENSIA Research Clinic at the Research Institute of Clinical Medicine
- Nationales Centrum fr Tumorerkrankungen NCT
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH
- Department of Dermatology, University of Mainz
- Universitätsmedizin Mannheim Dermatologie
- Universitaetsklinikum Wuerzburg
- Rabin Medical Center
- Tel Aviv Sourasky Medical CenterRecruiting
- Azienda Ospedaliera Spedali Civili di BresciaRecruiting
- Azienda Ospedaliera S.Croce e Carle Cuneo
- Istituto Nazionale dei TumoriRecruiting
- Istituto Clinico Humanitas
- Chungbuk National University HospitalRecruiting
- Jeonbuk National University HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Korea University Guro HospitalRecruiting
- Samsung Medical CenterRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Pusan National University Yangsan HospitalRecruiting
- ARENSIA Research Clinic at the Oncology Institute
- H. Vall d'HebronRecruiting
- START Barcelona HM Nou DelfosRecruiting
- Hospital Duran i Reynals - ICO L HospitaletRecruiting
- Hospital Universitario Insular de Gran Canaria
- Hospital Universitario Lucus AugustiRecruiting
- Clinica Universidad de NavarraRecruiting
- HM CIOCC Hospital Universitario HM SanchinarroRecruiting
- Hospital Clinico San CarlosRecruiting
- Hospital General Universitario Gregorio MaranRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- MD Anderson Cancer Center MadridRecruiting
- START Madrid - Hospital Universitario Fundacion Jimenez DiazRecruiting
- Hospital Universitario Virgen de la VictoriaRecruiting
- Clinica Universidad de NavarraRecruiting
- Complejo Hospitalario Universitario de Santiago (CHUS)Recruiting
- Hospital Virgen del RocioRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
- Chang Gung Memorial Hospital (CGMH) - Kaohsiung BranchRecruiting
- Kaohsiung Medical University Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- Taipei Medical University HospitalRecruiting
- Taipei Veterans General Hospital, VGHTPERecruiting
- Chang Gung Memorial Hospital Linkou BranchRecruiting
- Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Monotherapy - Dose Escalation and Dose Expansion parts
Combination Therapy - Dose Expansion Part
Arm Description
Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).
GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Dose-Limiting Toxicities (DLT)
Occurrence of Dose-Limiting Toxicities (DLT) assessed by the Investigator
Objective Response Rate (ORR)
Defined as proportion of participants who have a confirmed partial or complete response (PR or CR). Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Secondary Outcome Measures
Percentage of Subjects with Adverse Events and Serious Adverse Events
Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0
Duration of Object Response (DOR)
Defined as time from the first documentation of objective response (CR or PR) to the date of first PD or death.
Disease Control Rate (DCR)
Determined by Investigator Using RECIST Version 1.1
Progression-Free Survival (PFS)
Defined as the time from start of study treatment to first documented progression per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Overall survival (OS)
Defined as the time from start of study treatment to date of death due to any cause.
Dose Escalation: Maximum Concentration (Cmax) of GEN1042
Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Maximum Concentration (Cmax) of GEN1042
Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
Dose Escalation: Half-life (t1/2) of GEN1042
Dose Escalation: Half-life (t1/2) of GEN1042
Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042
Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042
Dose Expansion: Maximum Concentration (Cmax) of GEN1042
Dose Expansion: Maximum Concentration (Cmax) of GEN1042
Dose Escalation: Incidence of ADA response to GEN1042
Dose Escalation: Incidence of ADA response to GEN1042responses to GEN1042
Dose Expansion: Incidence of ADA response to GEN1042
Dose Expansion: Incidence of ADA response to GEN1042
Full Information
NCT ID
NCT04083599
First Posted
September 6, 2019
Last Updated
October 11, 2023
Sponsor
Genmab
Collaborators
BioNTech SE
1. Study Identification
Unique Protocol Identification Number
NCT04083599
Brief Title
GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
Official Title
A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
Collaborators
BioNTech SE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and anti-tumor activity of GEN1042 in patients with metastatic or locally advanced solid tumors.
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 subjects with metastatic or locally advanced solid tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Melanoma, Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Ductal Adenocarcinoma (PDAC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
647 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monotherapy - Dose Escalation and Dose Expansion parts
Arm Type
Experimental
Arm Description
Escalating doses of GEN1042 monotherapy in subjects with non-central nervous system (CNS) solid malignant tumors followed by monotherapy expansion cohorts at selected dose(s) in subjects with relapsed or refractory, advanced and/or metastatic melanoma, or non-small-cell lung cancer (NSCLC), or colorectal cancer (CRC).
Arm Title
Combination Therapy - Dose Expansion Part
Arm Type
Experimental
Arm Description
GEN1042 safety and efficacy will be evaluated in combination with pembrolizumab with or without chemotherapy in treatment-naive subjects with advanced or metastatic melanoma, non-small-cell lung cancer [NSCLC], head and neck squamous cell carcinoma [HNSCC], and pancreatic cancer.
Intervention Type
Biological
Intervention Name(s)
GEN1042
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Percentage of Subjects With Dose-Limiting Toxicities (DLT)
Description
Occurrence of Dose-Limiting Toxicities (DLT) assessed by the Investigator
Time Frame
First Cycle (21 days)
Title
Objective Response Rate (ORR)
Description
Defined as proportion of participants who have a confirmed partial or complete response (PR or CR). Determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame
From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)
Secondary Outcome Measure Information:
Title
Percentage of Subjects with Adverse Events and Serious Adverse Events
Description
Incidence of Adverse Events and Serious Adverse Events as assessed by NCI CTCAE V5.0
Time Frame
Baseline up to 90 Days After the Last Dose, assessed up to 36 months after the last subject's first treatment in the trial.
Title
Duration of Object Response (DOR)
Description
Defined as time from the first documentation of objective response (CR or PR) to the date of first PD or death.
Time Frame
From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)
Title
Disease Control Rate (DCR)
Description
Determined by Investigator Using RECIST Version 1.1
Time Frame
From the start of the study treatment until disease progression/death/ lost to follow-up/start of new anticancer therapy or withdrawal of consent, whichever occurs first. (an expected average of 10 months)
Title
Progression-Free Survival (PFS)
Description
Defined as the time from start of study treatment to first documented progression per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Time Frame
From the start of the study treatment until disease progression/death whichever occurs first. (an expected average of 10 months)
Title
Overall survival (OS)
Description
Defined as the time from start of study treatment to date of death due to any cause.
Time Frame
From the start of the study treatment until death due to any cause, assessed up to 36 months after the last subject's first treatment in the trial.
Title
Dose Escalation: Maximum Concentration (Cmax) of GEN1042
Description
Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Maximum Concentration (Cmax) of GEN1042
Time Frame
Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and End of Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)
Title
Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
Description
Pharmacokinetic (PK) parameters of GEN1042, and incidence of anti-drug antibodies Dose Escalation: Area Under the Concentration Time Curve (AUC) of GEN1042
Time Frame
Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and , End of GEN1042 Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)
Title
Dose Escalation: Half-life (t1/2) of GEN1042
Description
Dose Escalation: Half-life (t1/2) of GEN1042
Time Frame
Cycle (Cy) 1 Day (D) 1 before GEN1042 infusion (BI) and End of Infusion (EOI), Cy1 D2, 3, 8, 15, Cy2 BI, EOI on D1, D 2, 3, 8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)
Title
Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042
Description
Dose Expansion: Area Under the Concentration Time Curve (AUC) of GEN1042
Time Frame
Cy 1 BI, EOI on D1, D8, 15, Cy 2 BI, EOI on D1, D8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)
Title
Dose Expansion: Maximum Concentration (Cmax) of GEN1042
Description
Dose Expansion: Maximum Concentration (Cmax) of GEN1042
Time Frame
Cy 1 BI, EOI on D1, D8, 15, Cy 2 BI, EOI on D1, D8, 15, and then D1 of Cy 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment) (Cy =21 days)
Title
Dose Escalation: Incidence of ADA response to GEN1042
Description
Dose Escalation: Incidence of ADA response to GEN1042responses to GEN1042
Time Frame
BI on Cy 1, 2, 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment), safety follow-up visit (SFU) (30 and 90 days post final dose) (Cy =21 days)
Title
Dose Expansion: Incidence of ADA response to GEN1042
Description
Dose Expansion: Incidence of ADA response to GEN1042
Time Frame
BI on Cy 1, 2, 3, 5, 7, 11, 15 and every 4 cycles thereafter (up to end of treatment), SFU (30 and 90 days post final dose) (Cy =21 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 and tumor demonstrating PD-L1 IHC CPS ≥1.
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genmab A/S Trial Information
Phone
+4570202728
Email
clinicaltrials@genmab.com
Facility Information:
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer & Blood Specialty Clinic
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Individual Site Status
Recruiting
Facility Name
Moores Cancer Center at the UC San Diego Health
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
ChristianaCare
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Cancer Affiliates
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Maryland Oncology Hematology PA
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Cancer Institute - Forsyth (Medical Oncology)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente (KP) Oncology/Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Individual Site Status
Recruiting
Facility Name
Virgina Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Adventist Health System/Sunbelt,Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical Oncology Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Washington Health Services Association
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Rigshospitalet (Copenhagen University Hospital)
City
Copenhagen
Country
Denmark
Individual Site Status
Completed
Facility Name
Herlev University Hospital
City
Herlev
Country
Denmark
Individual Site Status
Recruiting
Facility Name
University Hospital of Southern Denmark, Vejle Hospital
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Centre hospitalier Universitaire de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Name
ARENSIA Research Clinic at the Research Institute of Clinical Medicine
City
Tbilisi
Country
Georgia
Individual Site Status
Not yet recruiting
Facility Name
Nationales Centrum fr Tumorerkrankungen NCT
City
Hamburg
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
Country
Germany
Individual Site Status
Completed
Facility Name
Department of Dermatology, University of Mainz
City
Mainz
Country
Germany
Individual Site Status
Completed
Facility Name
Universitätsmedizin Mannheim Dermatologie
City
Mannheim
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
Country
Germany
Individual Site Status
Completed
Facility Name
Rabin Medical Center
City
Petah tikva
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera S.Croce e Carle Cuneo
City
Cuneo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Istituto Nazionale dei Tumori
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Namdong
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
ARENSIA Research Clinic at the Oncology Institute
City
Chisinau
Country
Moldova, Republic of
Individual Site Status
Not yet recruiting
Facility Name
H. Vall d'Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
START Barcelona HM Nou Delfos
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Duran i Reynals - ICO L Hospitalet
City
L'Hospitalet De Llobregat
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Insular de Gran Canaria
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
HM CIOCC Hospital Universitario HM Sanchinarro
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maran
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS)
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch
City
Kaohsiung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Memorial Hospital
City
Kaohsiung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital, VGHTPE
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital Linkou Branch
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
Country
United Kingdom
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35688554
Citation
Muik A, Adams 3rd HC, Gieseke F, Altintas I, Schoedel KB, Blum JM, Sanger B, Burm SM, Stanganello E, Verzijl D, Spires VM, Vascotto F, Toker A, Quinkhardt J, Fereshteh M, Diken M, Satijn DPE, Kreiter S, Ahmadi T, Breij ECW, Tureci O, Sasser K, Sahin U, Jure-Kunkel M. DuoBody-CD40x4-1BB induces dendritic-cell maturation and enhances T-cell activation through conditional CD40 and 4-1BB agonist activity. J Immunother Cancer. 2022 Jun;10(6):e004322. doi: 10.1136/jitc-2021-004322. Erratum In: J Immunother Cancer. 2022 Sep;10(9):
Results Reference
derived
Learn more about this trial
GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
We'll reach out to this number within 24 hrs