A Phase 1/2 Study of Regn7075 (Egfrxcd28 Costimulatory Bispecific Antibody) in Combination with Cemiplimab in Patients with Advanced Solid Tumors
The main purpose of this study is to learn about the safety and tolerability of REGN7075 alone and in combination with cemiplimab and to find out what is the best dose of REGN7075 to be given to people with advanced solid tumors when combined with cemiplimab.
Currently participating in another study of a therapeutic agent
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
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
Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol
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
Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
Prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
Second malignancy that is progressing or requires active treatment as defined in the protocol
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
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
Untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
Encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
Any ongoing inflammatory skin disease as defined in the protocol
Other protocol-defined Inclusion/ Exclusion Criteria apply
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