RECRUITING

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

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Conditions

Advanced Solid TumorsVariety of mixed advanced solid tumor typesFirst in Human (FIH)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2020-12-21
Study Completion:2027-04-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04626635

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  2. 2. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
  3. 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. 4. Has at least 1 lesion that meets study criteria as defined in the protocol
  5. 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. 6. Has adequate organ and bone marrow function as defined in the protocol
  7. 7. In the judgement of the investigator, has a life expectancy of at least 3 months
  1. 1. Is currently participating in another study of a therapeutic agent
  2. 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. 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. 4. Has received recent anti-Epidermal Growth Factor Receptor (EGFR) antibody therapy as defined in the protocol
  5. 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. 6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
  7. 7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
  8. 8. Has second malignancy that is progressing or requires active treatment as defined in the protocol
  9. 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. 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. 11. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression
  12. 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. 13. Has any ongoing inflammatory skin disease as defined in the protocol

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
University of California Los Angeles (UCLA) Medical Center
Los Angeles, California, 90095
United States
The Regents of the University of California, San Francisco
San Francisco, California, 94118
United States
University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic
Aurora, Colorado, 80045
United States
University of Florida Health
Gainesville, Florida, 32608
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
University of Illinois Cancer Center
Chicago, Illinois, 60612
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts, 02215
United States
START Midwest - Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, 49546
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
The Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Sarah Cannon Research Institute - 25th Ave
Nashville, Tennessee, 37203
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
South Texas Oncology And Hematology
San Antonio, Texas, 78229
United States
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-21
Study Completion Date2027-04-07

Study Record Updates

Study Start Date2020-12-21
Study Completion Date2027-04-07

Terms related to this study

Keywords Provided by Researchers

  • Variety of mixed advanced solid tumor types
  • First in Human (FIH)

Additional Relevant MeSH Terms

  • Advanced Solid Tumors