Trial Title:
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
NCT ID:
NCT06581432
Condition:
Solid Tumours
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zongertinib
Description:
Zongertinib
Arm group label:
Zongertinib treatment
Other name:
BI 1810631
Summary:
This is a study for people with advanced cancer for whom previous treatment was not
successful or no treatment exists. 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 10 groups based on the type of advanced cancer and the type of
HER2 alterations they have. All participants take one dose of zongertinib. 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.
Criteria for eligibility:
Criteria:
Inclusion criteria:
- Signed and dated written informed consent in accordance with International Council
for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial.
- Patients ≥18 years old or over the legal age of consent in countries where that is
greater than 18 years at the time of signature of the Informed consent form (ICF).
- Documented (previously established by local testing) Human epidermal growth factor
receptor 2 (HER2) status of:
- HER2 overexpression/amplification
- Known activating HER2 mutations
- An archival (enrolment) tumour tissue sample must be submitted after inclusion of
the patient to retrospectively confirm the HER2 status (enrolment tissue sample). If
no archival tissue is available, this may be acceptable in exceptional cases after
written agreement with the sponsor. Please note that sample must not be from an area
irradiated prior to the biopsy.
- Patient who has failed conventional treatment or for whom no therapy of proven
efficacy exists or who is not eligible for established treatment options. Patient
must have exhausted, or not be a suitable candidate for, available treatment options
known to prolong survival for their disease.
Further inclusion criteria apply.
Exclusion criteria:
- Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
- Previous or concomitant malignancies other than the 1 treated in this trial within
the previous 3 years except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ
- other effectively treated malignancy that is considered cured by local
treatment
- Patients who must or wish to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial
- Not completely recovered from major surgery (major according to the investigator's
assessment) performed prior to screening or planned within 6 months after screening,
e.g. hip replacement Further exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Alaska Oncology and Hematology, LLC
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Precision NextGen Oncology
Address:
City:
Beverly Hills
Zip:
90212
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
BRCR Global
Address:
City:
Tamarac
Zip:
33321
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Memorial Sloan-Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Mary Crowley Cancer Research Center
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
833-602-2368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Macquarie University
Address:
City:
Macquarie Park
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
GenesisCare North Shore
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
1800271035
Email:
australia@bitrialsupport.com
Facility:
Name:
Centre Hospitalier de l'Universite de Montreal (CHUM)
Address:
City:
Montreal
Zip:
H2X 0A9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
18336022346
Email:
canada@bitrialsupport.com
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
4001200553
Email:
china@bitrialsupport.com
Facility:
Name:
Severance Hospital
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
0808802084
Email:
namhan@bitrialsupport.com
Facility:
Name:
Pan American Center for Oncology Trials, LLC
Address:
City:
Rio Piedras
Zip:
00935
Country:
Puerto Rico
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
18336022368
Email:
unitedstates@bitrialsupport.com
Facility:
Name:
Hospital A Coruña
Address:
City:
A Coruña
Zip:
15006
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Clínico San Carlos
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Clínica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Facility:
Name:
Hospital Virgen del Rocío
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Boehringer Ingelheim
Phone:
900876092
Email:
espana@bitrialsupport.com
Start date:
September 12, 2024
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Boehringer Ingelheim
Agency class:
Industry
Source:
Boehringer Ingelheim
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06581432
http://www.mystudywindow.com
