GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors
Malignant Solid Tumor, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
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
Experimental
Experimental
Monotherapy - Dose Escalation and Dose Expansion parts
Combination Therapy - Dose Expansion Part
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.