A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
NCT ID: NCT04626635
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
933 participants
INTERVENTIONAL
2020-12-21
2026-12-12
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Variety of mixed advanced solid tumor types
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion A
Triple Negative Breast Cancer (TNBC)
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion B
Cutaneous Squamous Cell Carcinoma (CSCC)
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion C
Non-Small Cell Lung Cancer (NSCLC)
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Platinum-based doublet chemotherapy
Administered IV Q3W
Dose Expansion D
Head and Neck Squamous Cell Carcinoma (HNSCC)
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion E
Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion F
MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases)
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion G
Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI)
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Platinum-based doublet chemotherapy
Administered IV Q3W
Dose Expansion H
EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Dose Expansion I
Third-line (3L) MSS-CRC with Active Liver Metastases
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Bevacizumab
Administered per protocol
Trifluridine-tipiracil
Administered per protocol
Dose Expansion J
3L MSS-CRC without Active Liver Metastases
REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Bevacizumab
Administered per protocol
Trifluridine-tipiracil
Administered per protocol
Interventions
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REGN7075
Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
Cemiplimab
Administered concomitantly Q3W by IV infusion or SC injection
Platinum-based doublet chemotherapy
Administered IV Q3W
Bevacizumab
Administered per protocol
Trifluridine-tipiracil
Administered per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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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
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
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)
Countries
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Central Contacts
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Other Identifiers
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2022-501234-37-00
Identifier Type: OTHER
Identifier Source: secondary_id
R7075-ONC-2009
Identifier Type: -
Identifier Source: org_study_id