Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors (COMBINE-EGFR-1)
Interventional
Phase 1/Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2020
décembre 2026
26 juin 2025
This study is researching an investigational drug called REGN7075 by itself and in
combination with cemiplimab with or without chemotherapy. The study is focused on
patients with certain solid tumors that are in an advanced stage. The aim of the study is
to see how safe and tolerable REGN7075 is by itself and in combination with cemiplimab
(with or without chemotherapy), and to find out what is the best dose of REGN7075 to be
given to patients with advanced solid tumors when combined with cemiplimab (with or
without chemotherapy). Another aim of the study is to see how effective REGN7075 by
itself, or in combination with cemiplimab (with or without chemotherapy), is at treating
cancer patients.
The study is also looking at:
- Side effects that may be experienced by people taking REGN7075 by itself and in
combination with cemiplimab with or without chemotherapy
- How REGN7075 works in the body by itself and in combination with cemiplimab with or
without chemotherapy
- How much REGN7075 is present in the blood when given by itself and in combination
with cemiplimab with or without chemotherapy
- To see if REGN7075 by itself and in combination with cemiplimab with or without
chemotherapy works to treat cancer by controlling the proliferation of tumor cells
to shrink the tumor
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Anas GAZZAH | 24/06/2024 09:10:14 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HIA BEGIN | 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 | |||||
| Centre Antoine Lacassagne - 06189 - Nice - Provence Alpes Cote dAzur - France | Contact (sur clinicalTrials) | ||||
| Centre Georges Francois Leclerc - 21034 - Dijon - Bourgogne Franche Comte - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire (CHU) de Poitiers - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - Auvergne - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL) - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Lyon Sud - 69310 - Pierre-Benite - Lyon - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud, IUCT-Oncopole - 31059 - Toulouse - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Has histologically or cytologically confirmed cancer that meets criteria as defined
in the protocol
3. Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed
cell death ligand-1 (PD-L1) naïve, defined as never having previously been treated
with a drug that targets the PD-1
4. Has at least 1 lesion that meets study criteria as defined in the protocol
5. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core
biopsy) from a tumor site that has not been previously irradiated
6. Has adequate organ and bone marrow function as defined in the protocol
7. In the judgement of the investigator, has a life expectancy of at least 3 months
Key
1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Has histologically or cytologically confirmed cancer that meets criteria as defined
in the protocol
3. Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed
cell death ligand-1 (PD-L1) naïve, defined as never having previously been treated
with a drug that targets the PD-1
4. Has at least 1 lesion that meets study criteria as defined in the protocol
5. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core
biopsy) from a tumor site that has not been previously irradiated
6. Has adequate organ and bone marrow function as defined in the protocol
7. In the judgement of the investigator, has a life expectancy of at least 3 months
Key
1. Is currently participating in another study of a therapeutic agent
2. Has participated in any study of an investigational agent or an investigational
device within 4 weeks of the first administration of study drug as defined in the
protocol
3. Has received treatment with an approved systemic therapy within 4 weeks of the first
administration of study drug or has not yet recovered (ie, grade 1 or baseline) from
any acute toxicities
4. Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as
defined in the protocol
5. Has received radiation therapy or major surgery within 14 days of the first
administration of study drug or has not recovered (ie, grade 1 or baseline) from
adverse events
6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4
weeks of first administration of study drug.
7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as
defined in the protocol
8. Has second malignancy that is progressing or requires active treatment as defined in
the protocol
9. Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg
prednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the first
dose of study drug as defined in the protocol
10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or
any other condition that required treatment with systemic immunosuppressive
treatments as defined in the protocol
11. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease,
or spinal cord compression
12. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or
uncontrolled seizures within 1 year prior to the first dose of study drug
13. Has any ongoing inflammatory skin disease as defined in the protocol
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply