A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
NCT ID: NCT03448042
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
123 participants
INTERVENTIONAL
2018-06-06
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Trastuzumab
Trastuzumab will be administered via IV infusion
Tocilizumab
Participants will receive IV tocilizumab if needed
Dose Expansion
Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Trastuzumab
Trastuzumab will be administered via IV infusion
Tocilizumab
Participants will receive IV tocilizumab if needed
Interventions
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Runimotamab
Runimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
Trastuzumab
Trastuzumab will be administered via IV infusion
Tocilizumab
Participants will receive IV tocilizumab if needed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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%
* 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
* 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 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Yale University
New Haven, Connecticut, United States
Washington University
Saint Louis, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Grand Hopital de Charleroi asbl
Charleroi, , Belgium
Princess Margaret Hospital
Toronto, Ontario, Canada
Rigshospitalet-Blegdamsvej 9
Copenhagen, , Denmark
EDOG - Institut Bergonie - PPDS
Bordeaux, Gironde, France
Centre Léon Bérard
Lyon, Rhône, France
Gustave Roussy
Villejuif, Val-de-Marne, France
Institut Claudius Regaud
Toulouse, , France
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan, Lombardy, Italy
National Cancer Center East
Chiba, , Japan
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
National Cancer Centre
Singapore, , Singapore
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
Madrid, , Spain
START MADRID_Hospital Universitario HM Sanchinarro - CIOCC - EDOS
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Countries
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Other Identifiers
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GO40311
Identifier Type: -
Identifier Source: org_study_id
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