Actively 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
Led by Regeneron Pharmaceuticals · Updated on 2026-04-09
933
Participants Needed
57
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
- For expansion cohorts only: Has never been treated with anti-PD-1/PD-L1 drugs
- Has at least one tumor lesion that meets study criteria
- Willing to provide a new biopsy sample from a tumor site not previously exposed to radiation
- Has adequate organ and bone marrow function as defined in the protocol
- Has a life expectancy of at least 3 months as judged by the investigator
You will not qualify if you...
- Currently participating in another study of a therapeutic agent
- Participated in a study of an investigational agent or device within 4 weeks before starting this study
- Received approved systemic therapy within 4 weeks before starting or not fully recovered from any acute toxicities
- Received recent anti-EGFR antibody therapy as defined in the protocol
- Received radiation therapy or major surgery within 14 days before starting or not recovered from related adverse events
- Received systemic, non-immunomodulatory biologic therapy within 4 weeks before starting
- Had prior anti-cancer immunotherapy within 5 half-lives before starting
- Has a progressing second malignancy requiring active treatment
- Requires ongoing corticosteroid therapy of more than 10 mg prednisone/day or equivalent within 1-2 weeks before first dose
- Has active or recent significant autoimmune disease or required systemic immunosuppressive treatment within 5 years
- Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
- Has had encephalitis, meningitis, organic brain disease, or uncontrolled seizures within 1 year before first dose
- Has any ongoing inflammatory skin disease as defined in the protocol
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Trial Site Locations
Total: 57 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
University of California Los Angeles (UCLA) Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
3
The Regents of the University of California, San Francisco
San Francisco, California, United States, 94118
Actively Recruiting
4
University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Florida Health
Gainesville, Florida, United States, 32608
Actively Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
7
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
8
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts, United States, 02215
Withdrawn
10
START Midwest - Cancer & Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
11
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
12
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
13
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
14
The Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Completed
15
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
16
Sarah Cannon Research Institute - 25th Ave
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
18
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
South Texas Oncology And Hematology
San Antonio, Texas, United States, 78229
Completed
20
University of Washington/Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
21
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
22
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
Lyon, Auvergne-Rhone, France, 69008
Actively Recruiting
23
Centre Jean Perrin
Clermont-Ferrand, Auvergne-Rhône, France, 63011
Withdrawn
24
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France, 69310
Actively Recruiting
25
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France, 21034
Actively Recruiting
26
Institut Claudius Regaud, IUCT-Oncopole
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
27
Centre Hospitalier Universitaire (CHU) de Lille
Lille, Hauts-de-France, France, 59000
Actively Recruiting
28
Institut Bergonie
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
29
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, New Aquitaine, France, 86021
Actively Recruiting
30
Nantes University Hospital
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
31
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, France, 06189
Actively Recruiting
32
Hospital Paris Saint-Joseph
Paris, France, 75014
Actively Recruiting
33
Begin Army Instruction Hospital
Saint-Mandé, Île-de-France Region, France, 94240
Actively Recruiting
34
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
35
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
36
Soroka University Medical Center
Beersheba, Israel, 84101
Actively Recruiting
37
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
38
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
39
Hadassah Medical Center
Jerusalem, Israel, 91220
Actively Recruiting
40
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
41
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
42
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
43
Medpolonia Sp. z o.o.
Poznan, Wielkopolska, Poland, 60-693
Actively Recruiting
44
Dom Lekarski SA
Szczecin, Zach, Poland, 70-784
Actively Recruiting
45
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195
Actively Recruiting
46
Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
47
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
48
Genesis Care Hospital San Francisco de Asis
Madrid, Spain, 28002
Actively Recruiting
49
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
50
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
51
Hospital 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
52
Hospital Clinico Universitario - University of Valencia
Valencia, Spain, 28040
Actively Recruiting
53
Baskent Universitesi
Yüreğir, Adana, Turkey (Türkiye), 01120
Actively Recruiting
54
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
55
Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye), 34450
Withdrawn
56
Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
Istanbul, Turkey (Türkiye), 81450
Actively Recruiting
57
Ciftlikkoy Campus Yenisehir Mersin
Mersin, Turkey (Türkiye), 33343
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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