Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

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

NCT ID NCT05537740

Disease control Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

Study facts

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

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

129 people

The number who actually took part.

Started

Oct 2022

Expected to finish

May 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.

Inclusion Criteria: * Capable of giving signed informed consent. * Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1. * Adequate renal and liver function. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception. * Female participants are eligible if they are not pregnant, not breastfeeding or not a Woman of childbearing potential (WOCBP). * Inclusion criterion for the dose-escalation: Individuals with histologically or cytologically confirmed, advanced or metastatic solid tumors. * Inclusion criteria for disease-specific combination expansion: Individuals with histologically or cytologically confirmed triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), gastric cancer, melanoma, or head and neck squamous cell carcinoma (HNSCC). * Inclusion criterion for the monotherapy-MoA expansion: Individuals with histologically or cytologically confirmed NSCLC, TNBC, HNSCC, or melanoma. * Willingness and medical feasibility (as per Investigator assessment) to undergo paired tumor biopsies with a non-significant risk. Exclusion Criteria: * A known additional malignancy that is progressing or has required active treatment within the past 3 years. * Primary central nervous system malignancy. * Major surgery ≤ 28 days before start of study treatment. * Any unresolved toxicity of Grade ≥ 2, not otherwise specified in other eligibility criteria, from previous anticancer treatment, except for alopecia and skin pigmentation. * Uncontrolled intercurrent illness requiring systemic treatment or solid organ transplant. * Known hypersensitivity to study treatment or any drugs similar in structure or class, including severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients. * Any prior immune-related toxicity (Grade 3 or 4) leading to discontinuation of immunotherapy. * History of congestive heart failure New York Heart Association (NYHA) \>II. * Medical history of (non-infectious) pneumonitis/interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically-active pneumonitis/ILD. * HIV-infection with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. * History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator. * Any other history, condition, therapy, or uncontrolled intercurrent illness which could in the opinion of the Investigator affect compliance with study requirements. * New brain metastases on screening brain MRI/CT; previously treated brain metastases that are progressive at screening or leptomeningeal disease. * Prior therapy with a C-C motif chemokine receptor 8 (CCR8) depleting antibody. * Prior allogeneic tissue/solid organ transplant. * Radiation therapy to the lung that is \> 30 Gy within 6 months before the start of study treatment. * Diagnosis of immunodeficiency or current chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent). * Active autoimmune disease that has required systemic treatment in the past 2 years.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

More trials for these conditions

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