A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers (NCT04626635) — USA Trial Details

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

REGN7075 →Cemiplimab →Platinum-based doublet chemotherapyBevacizumab →Trifluridine-tipiracil →

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

Study 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)

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

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

Primary outcome measure(s)

The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period — Up to 6 weeks
Dose escalation
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) — Approximately 90 days from last dose; up to 5 years
Dose escalation
Incidence and severity of Adverse Events of Special Interest (AESIs) — Approximately 90 days from last dose; up to 5 years
Dose escalation
Incidence and severity of Serious Adverse Events (SAEs) — Approximately 90 days from last dose; up to 5 years
Dose escalation
Incidence and severity of grade ≥3 laboratory abnormalities — Approximately 90 days from last dose; up to 5 years
Dose escalation
Objective Response Rate (ORR) — Up to 5 years
Dose expansion

Trial sites (54)

Facility	City	Region
Valkyrie Clinical Trials	Los Angeles	California
University of California Los Angeles (UCLA) Medical Center	Los Angeles	California
The Regents of the University of California, San Francisco	San Francisco	California
University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic	Aurora	Colorado
University of Florida Health	Gainesville	Florida
Moffitt Cancer Center	Tampa	Florida
University of Illinois Cancer Center	Chicago	Illinois
University of Iowa Hospitals and Clinics	Iowa City	Iowa
START Midwest - Cancer & Hematology Centers of Western Michigan, PC	Grand Rapids	Michigan
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
Memorial Sloan Kettering Cancer Center	New York	New York
University of Cincinnati Medical Center	Cincinnati	Ohio
The Stefanie Spielman Comprehensive Breast Center	Columbus	Ohio
Fox Chase Cancer Center	Philadelphia	Pennsylvania
Sarah Cannon Research Institute - 25th Ave	Nashville	Tennessee
Vanderbilt Ingram Cancer Center	Nashville	Tennessee
MD Anderson Cancer Center	Houston	Texas
South Texas Oncology And Hematology	San Antonio	Texas
University of Washington/Fred Hutchinson Cancer Center	Seattle	Washington
Medical College of Wisconsin	Milwaukee	Wisconsin
Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)	Lyon	Auvergne-Rhone
Hopital Lyon Sud	Pierre-Bénite	Auvergne-Rhône
Centre Georges Francois Leclerc	Dijon	Bourgogne-Franche-Comté
Institut Claudius Regaud, IUCT-Oncopole	Toulouse	Haute-Garonne
Centre Hospitalier Universitaire (CHU) de Lille	Lille	Hauts-de-France
Institut Bergonie	Bordeaux	New Aquitaine
Centre Hospitalier Universitaire (CHU) de Poitiers	Poitiers	New Aquitaine
Nantes University Hospital	Nantes	Pays de la Loire Region
Centre Antoine Lacassagne	Nice	Provence Alpes Cote dAzur
Hospital Paris Saint-Joseph	Paris	France
Begin Army Instruction Hospital	Saint-Mandé	Île-de-France Region
Gustave Roussy	Villejuif	Île-de-France Region
Sheba Medical Center	Ramat Gan	Central District
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

+ 14 more sites — see the full list on the official registry below.

On this site

📄 Libtayo (cemiplimab) drug profile → 📄 Avastin (bevacizumab) drug profile →

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