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New cancer combo aims to shrink Hard-to-Treat tumors

NCT ID NCT04626635

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This study tests a new drug called marlotamig (REGN7075) alone or with cemiplimab (Libtayo) and sometimes chemotherapy in people with advanced solid tumors. The goal is to find the safest dose and see if the combination can shrink tumors. About 933 participants are being recruited for this early-phase trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
marlotamig (REGN7075) combined with cemiplimab (Libtayo) and sometimes chemotherapy
What this could lead to
If it works, this could offer a new treatment option for people with advanced solid tumors that have stopped responding to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2), so the main goal is safety and dosing—not yet proof of effectiveness. Side effects from the drug combo could be serious, and many experimental cancer drugs fail in later stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

548 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

Contacts and locations

Locations

  • Baskent Universitesi

    Yüreğir, Adana, 01120, Turkey (Türkiye)

  • Begin Army Instruction Hospital

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

  • Centre Antoine Lacassagne

    Nice, Provence Alpes Cote dAzur, 06189, France

  • Centre Georges Francois Leclerc

    Dijon, Bourgogne-Franche-Comté, 21034, France

  • Centre Hospitalier Universitaire (CHU) de Lille

    Lille, Hauts-de-France, 59000, France

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, New Aquitaine, 86021, France

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

    Lyon, Auvergne-Rhone, 69008, France

  • Ciftlikkoy Campus Yenisehir Mersin

    Mersin, 33343, Turkey (Türkiye)

  • Dom Lekarski SA

    Szczecin, Zach, 70-784, Poland

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 06200, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Genesis Care Hospital San Francisco de Asis

    Madrid, 28002, Spain

  • Gustave Roussy

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

  • Hadassah Medical Center

    Jerusalem, 91220, Israel

  • Hopital Lyon Sud

    Pierre-Bénite, Auvergne-Rhône, 69310, France

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico Universitario - University of Valencia

    Valencia, 28040, Spain

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195, Spain

  • Hospital Paris Saint-Joseph

    Paris, 75014, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Institut Bergonie

    Bordeaux, New Aquitaine, 33076, France

  • Institut Claudius Regaud, IUCT-Oncopole

    Toulouse, Haute-Garonne, 31059, France

  • Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital

    Istanbul, 81450, Turkey (Türkiye)

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medpolonia Sp. z o.o.

    Poznan, Wielkopolska, 60-693, Poland

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Nantes University Hospital

    Nantes, Pays de la Loire Region, 44093, France

  • Netherlands Cancer Institute

    Amsterdam, 1066 CX, Netherlands

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

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

    Grand Rapids, Michigan, 49546, United States

  • Sarah Cannon Research Institute - 25th Ave

    Nashville, Tennessee, 37203, United States

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601, Israel

  • Soroka University Medical Center

    Beersheba, 84101, Israel

  • South Texas Oncology And Hematology

    San Antonio, Texas, 78229, United States

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Regents of the University of California, San Francisco

    San Francisco, California, 94118, United States

  • The Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212, United States

  • University of California Los Angeles (UCLA) Medical Center

    Los Angeles, California, 90095, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

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

    Aurora, Colorado, 80045, United States

  • University of Florida Health

    Gainesville, Florida, 32608, United States

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Washington/Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067, United States

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.