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
Interventional
Phase 1/Phase 2
Regeneron Pharmaceuticals (Voir sur ClinicalTrials)
décembre 2020
avril 2027
02 mars 2026
This study is researching an investigational drug called marlotamig (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 marlotamig is by itself and in
combination with cemiplimab (with or without chemotherapy), and to find out what is the
best dose of marlotamig 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 marlotamig 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 marlotamig by itself and in
combination with cemiplimab with or without chemotherapy
- How marlotamig works in the body by itself and in combination with cemiplimab with
or without chemotherapy
- How much marlotamig is present in the blood when given by itself and in combination
with cemiplimab with or without chemotherapy
- To see if marlotamig 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
- Whether the body makes antibodies against the study drugs (marlotamig and
cemiplimab) (which could make the drug less effective or could lead to side effects)
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 | 23/04/2026 13:15:07 | Contacter | ||
Critères
Tous
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 Exclusion Criteria:
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, Central Nervous System (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