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)
CTR Georges-Franรงois Leclerc
๐ซ๐ทDijon, France
Edegem - UNIV UZ Antwerpen
๐ง๐ชEdegem, Belgium
Alaska Oncology and Hematology, LLC
๐บ๐ธAnchorage, Alaska, United States
University of Arizona Comprehensive Cancer Center
๐บ๐ธTucson, Arizona, United States
Precision NextGen Oncology
๐บ๐ธBeverly Hills, California, United States
Scripps Cancer Center Torrey Pines
๐บ๐ธLa Jolla, California, United States
Valkyrie Clinical Trials
๐บ๐ธLos Angeles, California, United States
University of California Los Angeles
๐บ๐ธLos Angeles, California, United States
Yale University School of Medicine
๐บ๐ธNew Haven, Connecticut, United States
BRCR Global
๐บ๐ธTamarac, Florida, United States
Illinois Cancer Specialists
๐บ๐ธArlington Heights, Illinois, United States
Maryland Oncology Hematology, Columbia
๐บ๐ธColumbia, Maryland, United States
Karmanos Cancer Institute
๐บ๐ธDetroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
๐บ๐ธNew York, New York, United States
Memorial Sloan-Kettering Cancer Center
๐บ๐ธNew York, New York, United States
Alliance Cancer Specialists, PC, Wynnewood
๐บ๐ธWynnewood, Pennsylvania, United States
Mary Crowley Cancer Research Center
๐บ๐ธDallas, Texas, United States
The University of Texas MD Anderson Cancer Center
๐บ๐ธHouston, Texas, United States
Virginia Cancer Specialists, PC
๐บ๐ธFairfax, Virginia, United States
Macquarie University
๐ฆ๐บMacquarie Park, New South Wales, Australia
GenesisCare North Shore
๐ฆ๐บSt Leonards, New South Wales, Australia
Princess Alexandra Hospital
๐ฆ๐บWoolloongabba, Queensland, Australia
St John of God Subiaco Hospital
๐ฆ๐บSubiaco, Western Australia, Australia
Brussels - UNIV Saint-Luc
๐ง๐ชBruxelles, Belgium
BC Cancer Agency - Vancouver
๐จ๐ฆVancouver, British Columbia, Canada
Princess Margaret Cancer Centre
๐จ๐ฆToronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
๐จ๐ฆMontreal, Quebec, Canada
McGill University Health Centre (MUHC)
๐จ๐ฆMontreal, Quebec, Canada
The First Affiliated Hospital of Nanchang University
๐จ๐ณNanchang, China
Shanghai East Hospital
๐จ๐ณShanghai, China
Henan Cancer Hospital
๐จ๐ณZhengzhou, China
INS Bergonie
๐ซ๐ทBordeaux, France
HOP la Milรฉtrie
๐ซ๐ทPoitiers, France
INS Gustave Roussy
๐ซ๐ทVillejuif, France
Justus-Liebig Universitรคt Gieรen
๐ฉ๐ชGieรen, Germany
Asklepios Kliniken GmbH & Co. KGaA
๐ฉ๐ชHamburg, Germany
Universitรคt Leipzig
๐ฉ๐ชLeipzig, Germany
Universitรคtsklinikum Mannheim GmbH
๐ฉ๐ชMannheim, Germany
Klinikum rechts der Isar der Technischen Universitรคt Mรผnchen
๐ฉ๐ชMรผnchen, Germany
Az. Ospedaliere Umberto I di Ancona
๐ฎ๐นAncona, Italy
Istituto Scientifico Romagnolo
๐ฎ๐นMeldola (fc), Italy
ASST Grande Ospedale Metropolitano Niguarda
๐ฎ๐นMilano, Italy
AOU Universitร degli Studi della Campania Luigi Vanvitelli
๐ฎ๐นNapoli, Italy
Aichi Cancer Center Hospital
๐ฏ๐ตAichi, Nagoya, Japan
National Cancer Center Hospital East
๐ฏ๐ตChiba, Kashiwa, Japan
Osaka International Cancer Institute
๐ฏ๐ตOsaka, Osaka, Japan
Shizuoka Cancer Center
๐ฏ๐ตShizuoka, Sunto-gun, Japan
National Cancer Center Hospital
๐ฏ๐ตTokyo, Chuo-ku, Japan
Japanese Foundation for Cancer Research
๐ฏ๐ตTokyo, Koto-ku, Japan
Seoul National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Severance Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Nederlands Kanker Instituut
๐ณ๐ฑAmsterdam, Netherlands
Radboud Universitair Medisch Centrum
๐ณ๐ฑNijmegen, Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
๐ณ๐ดOslo, Norway
Pan American Center for Oncology Trials, LLC
๐ต๐ทRio Piedras, Puerto Rico
Hospital A Coruรฑa
๐ช๐ธA Coruรฑa, Spain
Hospital del Mar
๐ช๐ธBarcelona, Spain
Hospital Vall d'Hebron
๐ช๐ธBarcelona, Spain
Clรญnica Universidad de Navarra - Madrid
๐ช๐ธMadrid, Spain
Hospital Clรญnico San Carlos
๐ช๐ธMadrid, Spain
Clรญnica Universidad de Navarra
๐ช๐ธPamplona, Spain
Hospital Virgen del Rocรญo
๐ช๐ธSevilla, Spain