A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Running, not enrolling · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID

NCT03448042

Run by

Genentech, Inc.

People needed

123

Starts

2018-06-06

Expected to finish

2027-11-30

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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