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New antibody combo aims to boost immune attack on Hard-to-Treat cancers

NCT ID NCT05537740

Ongoing Disease control Sponsor: Bayer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This early-stage trial tests a new antibody, BAY 3375968, designed to help the immune system fight advanced solid tumors. It works by reducing regulatory T cells that can suppress immune activity. The study will test the drug alone and combined with pembrolizumab in about 129 people with cancers like lung, breast, head and neck, stomach, or melanoma. The main goals are to check safety, find the best dose, and see how the drug moves through the body.

What this could mean

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

Active substance
BAY 3375968 (also called Lanerkitug) and pembrolizumab
What this could lead to
If this works, it could offer a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 129 participants. The main goal is safety and dosing, not yet proving effectiveness. Side effects are unknown, and the drug may not work in humans as it did in animals.

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

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Conditions

The condition(s) this trial relates to.

melanoma neoplasm non-small cell lung carcinoma Recurrence Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

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

ADVANCED SOLID TUMORS

Contacts and locations

Locations

  • Antwerp University Hospital | Oncology Department

    Antwerp, Antwerp, 2650, Belgium

  • CHU de Liège

    Liège, 4000, Belgium

  • Centre Oscar Lambret - Service Oncologie

    Lille, Hauts-de-France, 59000, France

  • Clinica Universidad De Navarra | Madrid | Oncologia

    Madrid, 28027, Spain

  • Clinica Universidad De Navarra | Pamplona | Oncologia

    Pamplona, Navarre, 31008, Spain

  • Ghent University Hospital | Drug Research Unit Department

    Ghent, East Flanders, 9000, Belgium

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000, China

  • Hospital Universitari Vall D Hebron | Oncologia Medica

    Barcelona, 08035, Spain

  • Hospital Universitario Hm Sanchinarro | Oncologia Medica

    Madrid, 28050, Spain

  • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

    Bordeaux, New Aquitaine, 33000, France

  • Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)

    Villejuif, Île-de-France Region, 94805, France

  • Institut de Cancerologie Ouest - Saint Herblain - Oncologie medicale

    Saint-Herblain, Pays de la Loire Region, 44800, France

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000, China

  • LinYi Cancer Hospital (Linyi Tumor Hospital)

    Linyi, Shandong, 276001, China

  • National Cancer Center Singapore - Oncology Department

    Singapore, 168583, Singapore

  • National University Hospital Medical Centre

    Singapore, 119074, Singapore

  • OncoCare Cancer Centre | Gleneagles Medical Centre

    Singapore, 258499, Singapore

  • Princess Margaret Cancer Centre - Oncology Department

    Toronto, Ontario, M5G 2C4, Canada

  • Royal Marsden NHS Trust (Surrey)

    Sutton, Surrey, SM2 5PT, United Kingdom

  • START | San Antonio

    San Antonio, Texas, 78229, United States

  • South Texas Accelerated Research Therapeutics | START Rocky Mountain Region

    West Valley City, Utah, 84119, United States

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester, Greater Manchester, M204BX, United Kingdom

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655, China

  • The University of Chicago Medical Center - Hyde Park - Hematology & Oncology

    Chicago, Illinois, 60637, United States

  • UNC Hospitals - UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514, United States

  • Universitair Ziekenhuis Leuven | Gasthuisberg Campus - General Medical Oncology

    Leuven, Flemish Brabant, 3000, Belgium

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