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RECRUITING

NCT04626635

PHASE1/PHASE2

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

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

933

Start Date

2020-12-21

Completion Date

2027-04-07

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Advanced Solid Tumors

Interventions

DRUG

REGN7075

Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)

DRUG

Cemiplimab

Administered concomitantly Q3W by IV infusion or SC injection

DRUG

Platinum-based doublet chemotherapy

Administered IV Q3W

DRUG

Bevacizumab

Administered per protocol

DRUG

Trifluridine-tipiracil

Administered per protocol

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, Central Nervous System (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 (57)

Valkyrie Clinical Trials

Los Angeles, California, United States

University of California Los Angeles (UCLA) Medical Center

Los Angeles, California, United States

The Regents of the University of California, San Francisco

San Francisco, California, United States

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

Aurora, Colorado, United States

University of Florida Health

Gainesville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts, United States

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

Grand Rapids, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

The Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute - 25th Ave

Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

South Texas Oncology And Hematology

San Antonio, Texas, United States

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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

Lyon, Auvergne-Rhone, France

Centre Jean Perrin

Clermont-Ferrand, Auvergne-Rhône, France

Hopital Lyon Sud

Pierre-Bénite, Auvergne-Rhône, France

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, France

Institut Claudius Regaud, IUCT-Oncopole

Toulouse, Haute-Garonne, France

Centre Hospitalier Universitaire (CHU) de Lille

Lille, Hauts-de-France, France

Institut Bergonie

Bordeaux, Nouvelle-Aquitaine, France

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, Nouvelle-Aquitaine, France

Nantes University Hospital

Nantes, Pays de la Loire Region, France

Centre Antoine Lacassagne

Nice, Provence Alpes Cote dAzur, France

Hospital Paris Saint-Joseph

Paris, France

Begin Army Instruction Hospital

Saint-Mandé, Île-de-France Region, France

Gustave Roussy

Villejuif, Île-de-France Region, France

Sheba Medical Center

Ramat Gan, Central District, Israel

Soroka University Medical Center

Beersheba, Israel

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Netherlands Cancer Institute

Amsterdam, Netherlands

Erasmus MC

Rotterdam, Netherlands

Medpolonia Sp. z o.o.

Poznan, Wielkopolska, Poland

Dom Lekarski SA

Szczecin, Zach, Poland

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Genesis Care Hospital San Francisco de Asis

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital Clinico Universitario - University of Valencia

Valencia, Spain

Baskent Universitesi

Yüreğir, Adana, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye)

Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, Turkey (Türkiye)

Ciftlikkoy Campus Yenisehir Mersin

Mersin, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)