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Clinical Trial 21163

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04626635

Phase: Phase I/II
Principal Investigator: Khong, Hung

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or 1-800-679-0775 Learn More
Overview

Study Title

A Phase 1/2 Study of Regn7075 (Egfrxcd28 Costimulatory Bispecific Antibody) in Combination with Cemiplimab in Patients with Advanced Solid Tumors

Summary

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.

Objective

Treatments

Therapies

Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

Medications

Inclusion Criteria

Key Inclusion Criteria:

  • 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
  • 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
  • At least 1 lesion that meets study criteria as defined in the protocol
  • Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
  • Adequate organ and bone marrow function as defined in the protocol
  • In the judgement of the investigator, has a life expectancy of at least 3 months
  • Additional criteria apply

  • Exclusion Criteria

    Key Exclusion Criteria:

  • 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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.