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 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: R7075-ONC-20092022-501234-37-00
• Study Type: interventional
• Target: 548
• Locations: 7 countries
• Sites: 54

Brief 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)

Conditions

Advanced Solid Tumors

Keywords

Variety of mixed advanced solid tumor types; First in Human (FIH)

Outcome Measures

Primary Outcomes (6)

• The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period

  Dose escalation

  Up to 6 weeks

• Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

  Dose escalation

  Approximately 90 days from last dose; up to 5 years

• Incidence and severity of Adverse Events of Special Interest (AESIs)

  Dose escalation

  Approximately 90 days from last dose; up to 5 years

• Incidence and severity of Serious Adverse Events (SAEs)

  Dose escalation

  Approximately 90 days from last dose; up to 5 years

• Incidence and severity of grade ≥3 laboratory abnormalities

  Dose escalation

  Approximately 90 days from last dose; up to 5 years

• Objective Response Rate (ORR)

  Dose expansion

  Up to 5 years

Secondary Outcomes (39)

• Concentrations of marlotamig in serum

  Up to 5 years

• ORR

  Up to 5 years

• Progression Free Survival (PFS)

  Up to 5 years

• Duration of Response (DOR)

  Up to 5 years

• Disease Control Rate (DCR)

  Up to 5 years

Study Arms (11)

Dose Escalation

EXPERIMENTAL

Variety of mixed advanced solid tumor types

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion A

EXPERIMENTAL

Triple Negative Breast Cancer (TNBC)

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion B

EXPERIMENTAL

Cutaneous Squamous Cell Carcinoma (CSCC)

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion C

EXPERIMENTAL

Non-Small Cell Lung Cancer (NSCLC)

Drug: REGN7075; Drug: Cemiplimab; Drug: Platinum-based doublet chemotherapy

Dose Expansion D

EXPERIMENTAL

Head and Neck Squamous Cell Carcinoma (HNSCC)

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion E

EXPERIMENTAL

Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion F

EXPERIMENTAL

MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases)

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion G

EXPERIMENTAL

Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI)

Drug: REGN7075; Drug: Cemiplimab; Drug: Platinum-based doublet chemotherapy

Dose Expansion H

EXPERIMENTAL

EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy

Drug: REGN7075; Drug: Cemiplimab

Dose Expansion I

EXPERIMENTAL

Third-line (3L) MSS-CRC with Active Liver Metastases

Drug: REGN7075; Drug: Cemiplimab; Drug: Bevacizumab; Drug: Trifluridine-tipiracil

Dose Expansion J

EXPERIMENTAL

3L MSS-CRC without Active Liver Metastases

Drug: REGN7075; Drug: Cemiplimab; Drug: Bevacizumab; Drug: Trifluridine-tipiracil

Interventions

REGN7075 DRUG

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

Also known as: marlotamig

Dose Escalation; Dose Expansion A; Dose Expansion B; Dose Expansion C; Dose Expansion D; Dose Expansion E; Dose Expansion F; Dose Expansion G; Dose Expansion H; Dose Expansion I; Dose Expansion J

Cemiplimab DRUG

Administered concomitantly Q3W by IV infusion or SC injection

Also known as: REGN2810, Libtayo

Dose Escalation; Dose Expansion A; Dose Expansion B; Dose Expansion C; Dose Expansion D; Dose Expansion E; Dose Expansion F; Dose Expansion G; Dose Expansion H; Dose Expansion I; Dose Expansion J

Bevacizumab DRUG

Administered per protocol

Dose Expansion I; Dose Expansion J

Platinum-based doublet chemotherapy DRUG

Administered IV Q3W

Dose Expansion C; Dose Expansion G

Trifluridine-tipiracil DRUG

Administered per protocol

Dose Expansion I; Dose Expansion J

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Has at least 1 lesion that meets study criteria as defined in the protocol
• Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
• Has adequate organ and bone marrow function as defined in the protocol
• In the judgement of the investigator, has a life expectancy of at least 3 months

You may not qualify if:

• Is currently participating in another study of a therapeutic agent
• 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
• 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
• Has received recent anti-Epidermal Growth Factor Receptor (EGFR) antibody therapy as defined in the protocol
• 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
• Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
• Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
• Has second malignancy that is progressing or requires active treatment as defined in the protocol
• 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
• 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
• Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression
• Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
• Has any ongoing inflammatory skin disease as defined in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (54)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

University of California Los Angeles (UCLA) Medical Center

Los Angeles, California, 90095, United States

Location

The Regents of the University of California, San Francisco

San Francisco, California, 94118, United States

Location

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

Aurora, Colorado, 80045, United States

Location

University of Florida Health

Gainesville, Florida, 32608, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

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

Grand Rapids, Michigan, 49546, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

The Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, 43212, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Sarah Cannon Research Institute - 25th Ave

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

South Texas Oncology And Hematology

San Antonio, Texas, 78229, United States

Location

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

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

Lyon, Auvergne-Rhone, 69008, France

Location

Hopital Lyon Sud

Pierre-Bénite, Auvergne-Rhône, 69310, France

Location

Centre Georges Francois Leclerc

Dijon, Bourgogne-Franche-Comté, 21034, France

Location

Institut Claudius Regaud, IUCT-Oncopole

Toulouse, Haute-Garonne, 31059, France

Location

Centre Hospitalier Universitaire (CHU) de Lille

Lille, Hauts-de-France, 59000, France

Location

Institut Bergonie

Bordeaux, New Aquitaine, 33076, France

Location

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, New Aquitaine, 86021, France

Location

Nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

Location

Centre Antoine Lacassagne

Nice, Provence Alpes Cote dAzur, 06189, France

Location

Hospital Paris Saint-Joseph

Paris, 75014, France

Location

Begin Army Instruction Hospital

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

Location

Gustave Roussy

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

Location

Sheba Medical Center

Ramat Gan, Central District, 5265601, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah Medical Center

Jerusalem, 91220, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Medpolonia Sp. z o.o.

Poznan, Wielkopolska, 60-693, Poland

Location

Dom Lekarski SA

Szczecin, Zach, 70-784, Poland

Location

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Genesis Care Hospital San Francisco de Asis

Madrid, 28002, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario - University of Valencia

Valencia, 28040, Spain

Location

Baskent Universitesi

Yüreğir, Adana, 01120, Turkey (Türkiye)

Location

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, 06200, Turkey (Türkiye)

Location

Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

Istanbul, 81450, Turkey (Türkiye)

Location

Ciftlikkoy Campus Yenisehir Mersin

Mersin, 33343, Turkey (Türkiye)

Location

MeSH Terms

Interventions

cemiplimab; Bevacizumab; trifluridine tipiracil drug combination

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: December 21, 2020
• Primary Completion (Estimated): November 13, 2026
• Study Completion (Estimated): March 5, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), * the legal authority to share the data, * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (20); NL (2); FR (12); TU (4); PL (2); ES (8); IL (6)