A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
- Conditions
- Solid Tumors
- Interventions
- Registration Number
- NCT03448042
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation Runimotamab Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD). Dose Expansion Runimotamab Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation. Dose Escalation Trastuzumab Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD). Dose Escalation Tocilizumab Participants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD). Dose Expansion Tocilizumab Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation. Dose Expansion Trastuzumab Participants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events From baseline through end of study (approximately 78 months)
- Secondary Outcome Measures
Name Time Method Minimum Observed Serum Concentration (Cmin) of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year) Volume of Distribution at Steady State (Vss) of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year) Serum Concentration of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year) Objective Response (OR) as Determined by the Investigator According to Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) Baseline through the end of study (approximately 78 months) Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year) Maximum Observed Serum Concentration (Cmax) of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year) Clearance (CL) of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year) Duration of Response (DOR) From the first occurrence of a documented objective response to first documented disease progression or death from any cause, through the end of the study (approximately 78 months) Anti-Drug Antibody (ADA) Levels of Runimotamab At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Trial Locations
- Locations (27)
Centre Léon Bérard
🇫🇷Lyon, Rhône, France
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
START MADRID_Hospital Universiario Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Grand Hopital de Charleroi asbl
🇧🇪Charleroi, Belgium
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
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Rigshospitalet-Blegdamsvej 9
🇩🇰Copenhagen, Denmark
EDOG - Institut Bergonie - PPDS
🇫🇷Bordeaux, Gironde, France
Gustave Roussy
🇫🇷Villejuif, Val-de-Marne, France
Institut Claudius Regaud
🇫🇷Toulouse, France
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
🇮🇹Milano, Lombardia, Italy
National Cancer Center East
🇯🇵Chiba, Japan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
🇳🇱Amsterdam, Netherlands
National Cancer Centre
🇸🇬Singapore, Singapore
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcón, 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