A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

Launched by REGENERON PHARMACEUTICALS · Nov 6, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called REGN7075, which is being tested alone and in combination with another drug called cemiplimab, and possibly with chemotherapy, for adults with advanced solid tumors, or cancers that have spread and are harder to treat. The main goals of the study are to determine how safe REGN7075 is, what the best dose might be, and how effective it is at helping to shrink tumors. Researchers will also monitor any side effects that participants might experience and how the drug works in the body.

To participate in this study, patients generally need to be between 18 and 74 years old, have specific types of cancer confirmed by a doctor, and be in relatively good health (meaning they can carry out daily activities with little difficulty). Participants will need to provide a small sample of their tumor tissue and will be monitored closely throughout the trial. If you or a loved one are considering joining, it's crucial to discuss with your doctor to understand if this trial is a suitable option based on your individual health situation.

Gender

ALL

Eligibility criteria

• 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 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, 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