🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT03448042
Active, not recruiting Phase 1

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

NCT03448042 · tracked via the Priya Life Science UK tracker
Sponsor
Genentech, Inc.
Phase
Phase 1
Started
2018-06-06
Last updated
2026-08-26

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

RunimotamabTrastuzumabTocilizumab

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)

Trial sites (26)

FacilityCityRegionStatus
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 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
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

On this site

📄 Herceptin (trastuzumab) drug profile → 📄 Actemra (tocilizumab) drug profile →

More Genentech, Inc. trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT03448042 on ClinicalTrials.gov ↗ ← All trials in the UK