Informations générales (source: ClinicalTrials.gov)
A Phase 1 Dose Finding and Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Clinical Activity of Immunoradiotherapy Combinations as a Treatment Option in Subjects With Metastatic Solid Tumors
Interventional
Phase 1/Phase 2
Genmab (Voir sur ClinicalTrials)
mars 2023
août 2025
02 novembre 2025
The main purpose is to assess the safety and clinical activity of GEN1042 in combination
with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a
treatment option for participants with metastatic solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Eric DEUTSCH | 12/04/2024 08:07:14 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - 69008 - Lyon 2996944 - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Bergonie - 33076 - Bordeaux 3031582 - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- Participants with histologically confirmed non-central nervous system (CNS) solid
tumor that is metastatic and for whom there is no available standard therapy.
- At least 18 years of age.
- Signed informed consent prior to any screening procedures.
- Measurable disease according to RECIST v1.1.
- Life expectancy of >3 months.
- Qualify for palliative radiotherapy as an available option for disease management.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Normal or adequate liver, renal, cardiac and bone marrow function.
Key Exclusion Criteria:
- Prior malignancy except for non-melanoma skin cancers and in situ cancers.
- Condition contraindicating radiotherapy.
- Rapidly progressing disease.
- Active, known or suspected autoimmune disease.
- History of non-infectious pneumonitis that required steroids or currently has
pneumonitis.
- Contraindications to the use of pembrolizumab.
- Condition requiring systemic treatment with either corticosteroids or other
immunosuppressive medications within 14 days of first treatment.
- Received an allogeneic tissue/solid organ transplant.
- Active infection requiring systemic therapy.
Note: Other protocol defined inclusion and exclusion criteria may apply.