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New drug runimotamab takes on Hard-to-Treat HER2 cancers

NCT ID NCT03448042

Disease control Sponsor: Genentech, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called runimotamab, alone or with trastuzumab, in 123 people with advanced HER2-positive cancers. The main goal is to check safety and how the drug moves through the body. It is for patients whose cancer has spread or cannot be removed by surgery.

What this could mean

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

Active substance
runimotamab (with trastuzumab and tocilizumab as needed)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced HER2-positive cancers that are hard to treat.
What could go wrong
This is an early phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not work or could cause serious side effects.

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

123 people

The number who actually took part.

Started

Jun 2018

Expected to finish

Apr 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 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Adequate hematologic and end-organ function * Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade \</=1 prior to study entry * Left Ventricular Ejection Fraction (LVEF) \>/=50% HER2-Expressing Breast Cancer-Specific Inclusion Criteria * Locally tested, Human Epidermal Growth Factor Receptor 2 (HER2)-expressing BC * Locally advanced or metastatic BC that has relapsed or is refractory to established therapies HER2-Expressing Gastric/Gastroesophageal (GEJ) Cancer-Specific Inclusion Criteria * Adenocarcinoma of the stomach or GEJ with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy * HER2-expressing tumor (primary tumor or metastasis) as assessed by local lab testing * HER2-positive gastric/GEJ cancer must have received prior trastuzumab, cisplatin (or carboplatin or oxaliplatin or investigational platinum agent) and 5-fluorouracil (5-FU)/capecitabine HER2-Positive Solid Tumor Specific Inclusion Criteria * HER2-positive tumor (primary tumor or metastasis) as assessed by local (non-central) laboratory testing * Locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate; or for whom a clinical trial of an investigational agent is a recognized standard of care; or for whom a clinical trial of an investigational agent is considered an acceptable treatment option Exclusion Criteria * Pregnant or breastfeeding, or intending to become pregnant during the study or within 140 days after the last dose of runimotamab * Significant cardiopulmonary dysfunction * Known clinically significant liver disease * Positive for acute or chronic Hepatitis B virus (HBV) infection * Acute or chronic Hepatitis C virus (HCV) infection * Human Immunodeficiency Virus (HIV) seropositivity * Poorly controlled Type 2 diabetes mellitus * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias * Current treatment with medications that are well known to prolong the Q-wave/T-wave (QT) interval * Known clinically significant liver disease * Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control) * Leptomeningeal disease * Spinal cord compression that has not definitively treated with surgery and/or radiation * History of autoimmune disease * Prior allogeneic stem cell or solid organ transplantation

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Conditions

The condition(s) this trial relates to.

gastric cancer gastroesophageal junction adenocarcinoma HER2 positive breast carcinoma

As listed by the trial registrant

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

Solid tumors

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

    Milan, Lombardy, 20162, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Centre Léon Bérard

    Lyon, Rhône, 69008, France

  • China Medical University Hospital

    Taichung, 40447, Taiwan

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LJ, United Kingdom

  • EDOG - Institut Bergonie - PPDS

    Bordeaux, Gironde, 33000, France

  • Grand Hopital de Charleroi asbl

    Charleroi, 6000, Belgium

  • Gustave Roussy

    Villejuif, Val-de-Marne, 94805, France

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX, Netherlands

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10017, United States

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Rigshospitalet-Blegdamsvej 9

    Copenhagen, 2100, Denmark

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START MADRID_Hospital Universiario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC - EDOS

    Madrid, 28050, Spain

  • Seoul National University Hospital

    Seoul, 110-744, South Korea

  • Washington University

    Saint Louis, Michigan, 63130, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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