Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study start
estimated completion

Description

Summary

This study is researching an investigational drug called 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 REGN7075 is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of REGN7075 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 REGN7075 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 REGN7075 by itself and in combination with cemiplimab with or without chemotherapy.
  • How REGN7075 works in the body by itself and in combination with cemiplimab with or without chemotherapy.
  • How much REGN7075 is present in your blood when given by itself and in combination with cemiplimab with or without chemotherapy.
  • To see if REGN7075 by itself and in combination with cemiplimab with or without chemotherapy works to treat your cancer by controlling the proliferation of tumor cells to shrink your tumor.

Official Title

A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Keywords

Advanced Solid Tumors, Variety of mixed advanced solid tumor types, First in Human (FIH), Cemiplimab, REGN7075, Platinum-based doublet chemotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • The Regents of the University of California, San Francisco (UCSF) accepting new patients
    San Francisco California 840011 United States
  • START - South Texas Accelerated Research Therapeutics, LLC accepting new patients
    San Antonio Texas 78229 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT04626635
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 769 study participants
Last Updated