Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
- Registration Number
- NCT06581432
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.
Participants are put into 13 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.
Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zongertinib treatment Zongertinib -
- Primary Outcome Measures
Name Time Method Proportion of patients with objective response (OR) Up to 37 months Objective response (OR) is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as assessed by central independent review, from the date of treatment start until the earliest date of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or trial treatment discontinuation.
- Secondary Outcome Measures
Name Time Method Duration of objective response (DOR) Up to 37 months Duration of objective response (DOR) is defined as the time from first documented confirmed Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review.
Progression-Free Survival (PFS) Up to 37 months PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first.
Disease control (DC) Up to 37 months Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review.
Occurrence of treatment-emergent Adverse Events (AEs) Up to 37 months Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, item list (EORTC IL19) At baseline and up to 48 weeks The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much".
Trial Locations
- Locations (64)
Alaska Oncology and Hematology, LLC
🇺🇸Anchorage, Alaska, United States
University of Arizona Comprehensive Cancer Center
🇺🇸Tucson, Arizona, United States
Precision NextGen Oncology
🇺🇸Beverly Hills, California, United States
Scripps Cancer Center Torrey Pines
🇺🇸La Jolla, California, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
BRCR Global
🇺🇸Tamarac, Florida, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Community MD Anderson Cancer Center - East Medical Oncology
🇺🇸Indianapolis, Indiana, United States
Maryland Oncology Hematology, Columbia
🇺🇸Columbia, Maryland, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Alliance Cancer Specialists, PC, Wynnewood
🇺🇸Wynnewood, Pennsylvania, United States
Mary Crowley Cancer Research Center
🇺🇸Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Macquarie University
🇦🇺Macquarie Park, New South Wales, Australia
GenesisCare North Shore
🇦🇺St Leonards, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
St John of God Subiaco Hospital
🇦🇺Subiaco, Western Australia, Australia
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
BC Cancer Agency - Vancouver
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Shanghai East Hospital
🇨🇳Shanghai, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
INS Bergonie
🇫🇷Bordeaux, France
CTR Georges-François Leclerc
🇫🇷Dijon, France
HOP la Milétrie
🇫🇷Poitiers, France
INS Gustave Roussy
🇫🇷Villejuif, France
Justus-Liebig Universität Gießen
🇩🇪Gießen, Germany
Asklepios Kliniken GmbH & Co. KGaA
🇩🇪Hamburg, Germany
Universität Leipzig
🇩🇪Leipzig, Germany
Universitätsklinikum Mannheim GmbH
🇩🇪Mannheim, Germany
Klinikum rechts der Isar der Technischen Universität München
🇩🇪München, Germany
Az. Ospedaliere Umberto I di Ancona
🇮🇹Ancona, Italy
Istituto Scientifico Romagnolo
🇮🇹Meldola (fc), Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
AOU Università degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Italy
Aichi Cancer Center Hospital
🇯🇵Aichi, Nagoya, Japan
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Osaka, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Sunto-gun, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Chuo-ku, Japan
Japanese Foundation for Cancer Research
🇯🇵Tokyo, Koto-ku, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Nederlands Kanker Instituut
🇳🇱Amsterdam, Netherlands
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
🇳🇴Oslo, Norway
Pan American Center for Oncology Trials, LLC
🇵🇷Rio Piedras, Puerto Rico
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Clínica Universidad de Navarra - Madrid
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain