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
Study summary
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-expressing cancers.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Percentage of Participants with Adverse Events — From baseline through end of study (approximately 78 months)
Trial sites (26)
Facility
City
Region
Status
Yale University
New Haven
Connecticut
Washington University
Saint Louis
Michigan
Memorial Sloan Kettering Cancer Center
New York
New York
SCRI Oncology Partners
Nashville
Tennessee
MD Anderson Cancer Center
Houston
Texas
Peter MacCallum Cancer Centre
Melbourne
Victoria
Grand Hopital de Charleroi asbl
Charleroi
Belgium
Princess Margaret Hospital
Toronto
Ontario
Rigshospitalet-Blegdamsvej 9
Copenhagen
Denmark
EDOG - Institut Bergonie - PPDS
Bordeaux
Gironde
Centre Léon Bérard
Lyon
Rhône
Gustave Roussy
Villejuif
Val-de-Marne
Institut Claudius Regaud
Toulouse
France
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milan
Lombardy
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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