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New drug combo takes on aggressive breast cancer

NCT ID NCT05852691

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This phase 2 trial tests a new immunotherapy drug called tobemstomig combined with chemotherapy (nab-paclitaxel) against the standard combination of pembrolizumab plus chemotherapy. It includes 83 people with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. The goal is to see if the new combo delays cancer growth better than the current standard.

What this could mean

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

Active substance
Tobemstomig (an immunotherapy drug) combined with nab-paclitaxel (chemotherapy)
What this could lead to
If it works, this could offer a new treatment option for people with a tough-to-treat breast cancer, potentially improving how long the cancer stays under control.
What could go wrong
This is a phase 2 trial with only 83 people, so results are preliminary. The new drug may not work better than the existing treatment, and side effects are unknown.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

83 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Oct 2026

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: * Metastatic or locally advanced unresectable, histologically documented triple-negative breast cancer (TNBC) (absence of HER2-over-expression, ER, and PgR expression by local assessment) * HER2-low-status * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * If metastatic disease (Stage IV), measurable disease outside of the bone * No prior systemic therapy for metastatic or locally advanced unresectable TNBC * Tumor PD-L1 expression as documented through central testing of a representative tumor tissue specimen * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and end-organ function * Negative HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/uL, and have an undetectable viral load * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening, or a negative HBsAb at screening accompanied by either of the following: negative hepatitis B core antibody (HBcAb); positive HBcAb test followed by quantitative hepatitis B virus (HBV) DNA \< 500 IU/mL * Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening * Adequate cardiovascular function Exclusion Criteria: * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 4 months after the final dose of tobemstomig or pembrolizumab, and 6 months after the final dose of nab-paclitaxel * Poor venous access * History of malignancy within 5 years prior to consent, except for the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * History of leptomeningeal disease * Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Hypercalcemia or hypercalcemia that is symptomatic * Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis (granulomatosis with polyangiitis), Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Active tuberculosis (TB) * Significant cardiovascular/cerebrovascular disease within 3 months prior to consent * History or presence of an abnormal ECG that is deemed clinically significant * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome * Major surgical procedure within 4 weeks prior to initiation of study treatment * Treatment with therapeutic oral or IV antimicrobials (anti-bacterial, anti-fungal, antiviral, anti-parasitic) within 1 week prior to initiation of study treatment * Prior allogeneic stem cell or solid organ transplantation * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications * Treatment with a live, attenuated vaccine within 28 days prior to initiation of study treatment * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Prior treatment with CD137 agonists or anti-CTLA therapeutic antibodies or an anti-LAG3 agent * Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment * Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 2 weeks prior to initiation of study treatment * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tobemstomig or pembrolizumab formulation * Known allergy or hypersensitivity to any component of the to nab-paclitaxel formulation

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • ?wi?tokrzyskie Centrum Onkologii

    Kielce, 25-734, Poland

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Cancer Blood and Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Centro Medico Monte Carmelo

    Arequipa, 04001, Peru

  • Centro Médico Zambrano Hellion

    Monterrey, Nuevo León, 66278, Mexico

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020, Mexico

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L

    Buenos Aires, C1113AAE, Argentina

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001, Brazil

  • Dres. Andreas Köhler und Roswitha Fuchs

    Langen, 63225, Germany

  • Fakultni Thomayerova nemocnice

    Praha 4 - Krc, 140 59, Czechia

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273, South Korea

  • Hadassah University Hospital - Ein Kerem

    Jerusaelm, 9112001, Israel

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000, Brazil

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34, Peru

  • Instituto Peruano de Oncología y Radioterapia

    Lima, Peru

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

    Essen, 45136, Germany

  • Komarom-Eszergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800, Hungary

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196, South Africa

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • National Taiwan Uni Hospital

    Taipei, 100, Taiwan

  • Novant Health Presbyterain Medical Center

    Charlotte, North Carolina, 28204, United States

  • OncoMed

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Oncosalud Sac

    Lima, 41, Peru

  • Ospedale Provinciale Santa Maria Delle Croci

    Ravenna, Emilia-Romagna, 48100, Italy

  • Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Sheba Medical Center

    Ramat Gan, 5262100, Israel

  • Sunshine Hospital

    St Albans, Victoria, Australia

  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

    Krakow, 31-501, Poland

  • Universitätsklinikum Ulm Am Michelsberg

    Ulm, 89075, Germany

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