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

Last updated: December 2, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

REGN7075

Bevacizumab

Trifluridine-tipiracil

Clinical Study ID

NCT04626635
R7075-ONC-2009
2022-501234-37-00
  • Ages > 18
  • All Genders

Study 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 the 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 cancer by controlling the proliferation of tumor cells to shrink the tumor

Eligibility Criteria

Inclusion

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 definedin the protocol

  3. Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmedcell death ligand-1 (PD-L1) naïve, defined as never having previously been treatedwith 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 corebiopsy) 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

Exclusion

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 investigationaldevice within 4 weeks of the first administration of study drug as defined in theprotocol

  3. Has received treatment with an approved systemic therapy within 4 weeks of the firstadministration of study drug or has not yet recovered (ie, grade 1 or baseline) fromany acute toxicities

  4. Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy asdefined in the protocol

  5. Has received radiation therapy or major surgery within 14 days of the firstadministration of study drug or has not recovered (ie, grade 1 or baseline) fromadverse events

  6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4weeks of first administration of study drug.

  7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug asdefined in the protocol

  8. Has second malignancy that is progressing or requires active treatment as defined inthe protocol

  9. Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mgprednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the firstdose of study drug as defined in the protocol

  10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease orany other condition that required treatment with systemic immunosuppressivetreatments 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) oruncontrolled 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

Study Design

Total Participants: 933
Treatment Group(s): 6
Primary Treatment: REGN7075
Phase: 1/2
Study Start date:
December 21, 2020
Estimated Completion Date:
December 12, 2026

Connect with a study center

  • Centre Jean Perrin

    Clermont-Ferrand, Auvergne 63011
    France

    Site Not Available

  • Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

    Lyon 2996944, Auvergne-Rhone 69008
    France

    Active - Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand 3024635, Auvergne-Rhône 63011
    France

    Site Not Available

  • Hopital Lyon Sud

    Pierre-Bénite 2987314, Auvergne-Rhône 69310
    France

    Active - Recruiting

  • Centre Jean Perrin - Centre Regional de Lutte contre le Cancer d Auvergne

    Clermont Ferrand, Auvergne-Rhône-Alpes 63011
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne Franche Comte 21034
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon 3021372, Bourgogne-Franche-Comté 11071619 21034
    France

    Active - Recruiting

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse, Haute-Garonne 31059
    France

    Site Not Available

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse 2972315, Haute-Garonne 31059
    France

    Active - Recruiting

  • Begin Army Instruction Hospital

    Saint-Mande, Ile De France 94240
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, Ile De France 94800
    France

    Site Not Available

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif, Ile De France 94805
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon Cedex 08, Lyon 69008
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Groupement Hospitalier Sud

    Pierre Benite, Lyon 69495
    France

    Site Not Available

  • Hopital Lyon Sud

    Pierre-Benite, Lyon 69310
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux, Nouvelle-Aquitaine 33076
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux 3031582, Nouvelle-Aquitaine 11071620 33076
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers 2986495, Nouvelle-Aquitaine 11071620 86021
    France

    Active - Recruiting

  • Nantes University Hospital

    Nantes 2990969, Pays de la Loire Region 2988289 44093
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice, Provence Alpes Cote dAzur 06189
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice 2990440, Provence Alpes Cote dAzur 06189
    France

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice Cedex 2, Provence-Alpes-Côte d'Azur 06189
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Begin Army Instruction Hospital

    Saint-Mandé 2978621, Île-de-France Region 3012874 94240
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif 2968705, Île-de-France Region 3012874 94800
    France

    Active - Recruiting

  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    Bordeaux, 33000
    France

    Active - Recruiting

  • Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)

    Lyon, 69008
    France

    Site Not Available

  • Hospital Paris Saint-Joseph

    Paris 2988507, 75014
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, Central District 294904 5265601
    Israel

    Active - Recruiting

  • Soroka University Medical Center

    Be'er Sheva, 84101
    Israel

    Site Not Available

  • Soroka University Medical Center

    Beersheba 295530, 84101
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa 294801, 3109601
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 91220
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem 281184, 91220
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem 281184, 9103102
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv 293397, 64239
    Israel

    Active - Recruiting

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX
    Netherlands

    Site Not Available

  • Netherlands Cancer Institute

    Amsterdam 2759794, 1066 CX
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam 2747891, 3015 GD
    Netherlands

    Active - Recruiting

  • Medpolonia Sp. z o.o.

    Poznan, Wielkopolska 60-693
    Poland

    Site Not Available

  • Medpolonia Sp. z o.o.

    Poznan 3088171, Wielkopolska 60-693
    Poland

    Active - Recruiting

  • Dom Lekarski SA

    Szczecin, Zach 70-784
    Poland

    Site Not Available

  • Dom Lekarski SA

    Szczecin 3083829, Zach 70-784
    Poland

    Active - Recruiting

  • Hospital General de Catalunya

    Sant Cugat del Valles, Barcelona 08195
    Spain

    Site Not Available

  • Hospital General de Catalunya

    Sant Cugat del Vallès 3110718, Barcelona 08195
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia 08035
    Spain

    Active - Recruiting

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • University Hospital Quironsalud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón 3112989, Madrid 3117732 28223
    Spain

    Active - Recruiting

  • Hospital Universitari General de Catalunya

    Barcelona, 08195
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Start Madrid-FJD, Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Genesis Care Hospital San Francisco de Asis

    Madrid 3117735, 28002
    Spain

    Active - Recruiting

  • Hospital 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario - University of Valencia

    Valencia, 28040
    Spain

    Site Not Available

  • Hospital Clinico Universitario-University of Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario - University of Valencia

    Valencia 2509954, 28040
    Spain

    Active - Recruiting

  • Baskent Universitesi

    Yuregir, Adana 01120
    Turkey

    Site Not Available

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200
    Turkey

    Site Not Available

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450
    Turkey

    Active - Recruiting

  • Istanbul Medeniyet University Prof.Dr.Suleyman Yalcin Şehir Hospital

    Istanbul, 81450
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34450
    Turkey

    Active - Recruiting

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul, 34450
    Turkey

    Site Not Available

  • Baskent Universitesi

    Yüreğir 323716, Adana 325361 01120
    Turkey (Türkiye)

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara 323786, 06200
    Turkey (Türkiye)

    Active - Recruiting

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul 745044, 81450
    Turkey (Türkiye)

    Active - Recruiting

  • Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

    Istanbul 745044, 34450
    Turkey (Türkiye)

    Site Not Available

  • Ciftlikkoy Campus Yenisehir Mersin

    Mersin 304531, 33343
    Turkey (Türkiye)

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California Los Angeles (UCLA) Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • The Regents of the University of California, San Francisco

    San Francisco, California 94118
    United States

    Site Not Available

  • The Regents of the University of California, San Francisco (UCSF)

    San Francisco, California 840011
    United States

    Active - Recruiting

  • University of California Los Angeles (UCLA) Medical Center

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles 5368361, California 5332921 90067
    United States

    Active - Recruiting

  • The Regents of the University of California, San Francisco

    San Francisco 5391959, California 5332921 94118
    United States

    Active - Recruiting

  • University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • University of Florida Health

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Florida Health

    Gainesville 4156404, Florida 4155751 32608
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Completed

  • University of Illinois Cancer Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • University of Illinois Cancer Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52240
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute Brookline Avenue

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana Farber Cancer Institute Brookline Avenue

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • START Midwest - Cancer & Hematology Centers of Western Michigan, PC

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • START Midwest - Cancer & Hematology Centers of Western Michigan, PC

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43212
    United States

    Site Not Available

  • The Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio 43212-3117
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • The Stefanie Spielman Comprehensive Breast Center

    Columbus 4509177, Ohio 5165418 43212
    United States

    Completed

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19111
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute - 25th Ave

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute - 25th Ave

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • START - South Texas Accelerated Research Therapeutics, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • South Texas Oncology And Hematology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • South Texas Oncology And Hematology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Completed

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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