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Phase I/2 study
REGN7075  in Combination With Cemiplimab
REGN7075: EGFRxCD28 Costimulatory Bispecific Antibody (bsAb), aims to restore immune sensitivity in traditionally non-immunoresponsive tumors by bridging CD28+ T cells with EGFR-expressing tumor cells (unlike other bsAbs that target CD3), facilitating T-cell activation through endogenous tumor antigens.
Cemiplimab: checkpoint inhibitor, anti PD-1 (Libatyo)
Microsatellite-Stable Colorectal Cancer (MSS CRC) is one of the dose expansion arms.

ASCO 2024: “Of the 15 patients with MSS CRC without liver metastases treated with active REGN7075 doses, overall response rate was 20% and disease control rate was 80% (1 patient had a complete response; 2 partial responses; 9 with stable disease). After data cutoff, 1 additional patient with liver metastases achieved partial response”. See Helpful Links.

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Criterios de inclusión

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 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

Criterios de exclusión

Criterios de exclusión:

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