A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Regeneron Pharmaceuticals
Summary
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key 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…
Interventions
- DrugREGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
- DrugCemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
- DrugPlatinum-based doublet chemotherapy
Administered IV Q3W
- DrugBevacizumab
Administered per protocol
- DrugTrifluridine-tipiracil
Administered per protocol
Locations (57)
- Valkyrie Clinical TrialsLos Angeles, California
- University of California Los Angeles (UCLA) Medical CenterLos Angeles, California
- The Regents of the University of California, San FranciscoSan Francisco, California
- University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer ClinicAurora, Colorado
- University of Florida HealthGainesville, Florida
- Moffitt Cancer CenterTampa, Florida