Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors.
Alison M Schram, John J Park, Antoine Italiano...
https://pubmed.ncbi.nlm.nih.gov/41777164Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06581432
Beamion PANTUMOR-1: A Study to Evaluate Oral Zongertinib for Advanced HER2-mutated or Overexpressed Solid Tumors
Led by Boehringer Ingelheim · Updated on 2026-04-29
430
Participants Needed
88
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the medicine zongertinib helps adults aged 18 and over with advanced cancers that have HER2 alterations. These alterations can cause cancer to grow, and zongertinib works by blocking HER2. This Phase II trial focuses on people whose previous cancer treatments were not successful and who have advanced solid tumors with specific HER2 mutations or overexpression. Participants are assigned to groups based on their type of advanced cancer, the HER2 alteration type, and the daily dose of zongertinib they receive. There are two different doses of zongertinib taken each day, and participants can continue treatment as long as they benefit and tolerate it. The study is open-label and multicenter, involving oral administration of the drug. During the study, participants regularly visit the study site where doctors measure tumor size and check for spread to other body parts. Health status and any side effects are closely monitored at each visit. Researchers measure the proportion of patients who respond to treatment, duration of response, disease progression, adverse events, quality of life changes, and overall survival over up to 51 months of follow-up.
CONDITIONS
Brief Title
Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before joining the trial
- Adults aged 18 years or older (or legal age of consent in your country)
- Documented HER2 status showing amplification or activating mutations
- Willing and able to provide a sample of tumor tissue
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor
- Received at least one prior line of therapy for metastatic disease
- Patients unlikely to tolerate or benefit from further standard care therapies known to prolong survival
You will not qualify if you...
- Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
- Previous or other current cancers within the past 3 years, except effectively treated non-melanoma skin cancer, carcinoma in situ of cervix or breast, localized prostate cancer under surveillance, or other cured malignancies
- Use of medications that interfere with the safe conduct of the trial
- Not fully recovered from major surgery prior to screening or planned within 6 months after screening
- Other exclusion criteria as assessed by the investigator may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 51 months
Participants receive oral Zongertinib for advanced HER2-mutated or overexpressed solid tumors.
Visits scheduled throughout treatment as per protocol
Trial Site Locations
Total: 88 locations
1
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
University of Arizona Comprehensive Cancer Center
Tucson, Arizona, United States, 85719
Not Yet Recruiting
3
Precision NextGen Oncology
Beverly Hills, California, United States, 90212
Actively Recruiting
4
Scripps Cancer Center Torrey Pines
La Jolla, California, United States, 92037
Not Yet Recruiting
5
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
6
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
7
BRCR Global
Tamarac, Florida, United States, 33321
Actively Recruiting
8
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Not Yet Recruiting
9
Community MD Anderson Cancer Center - East Medical Oncology
Indianapolis, Indiana, United States, 46219
Actively Recruiting
10
Maryland Oncology Hematology, Columbia
Columbia, Maryland, United States, 21044
Not Yet Recruiting
11
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Not Yet Recruiting
12
Presbyterian Healthcare Services
Albuquerque, New Mexico, United States, 87110
Not Yet Recruiting
13
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
14
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
15
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Not Yet Recruiting
16
Alliance Cancer Specialists, PC, Wynnewood
Wynnewood, Pennsylvania, United States, 19096
Not Yet Recruiting
17
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States, 75230
Not Yet Recruiting
18
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
Texas Oncology - Plano West
Plano, Texas, United States, 75093
Not Yet Recruiting
20
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
21
Macquarie University
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
22
GenesisCare North Shore
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
23
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
24
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia, 6008
Actively Recruiting
25
Cancer Research South Australia
Adelaide, Australia
Not Yet Recruiting
26
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
27
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
28
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
29
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Not Yet Recruiting
30
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
31
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Not Yet Recruiting
32
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
33
Peking University First Hospital
Beijing, China, 100034
Not Yet Recruiting
34
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, China, 310016
Not Yet Recruiting
35
Anhui Provincial Cancer Hospital
Hefei, China, 230001
Not Yet Recruiting
36
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
37
Shanghai East Hospital
Shanghai, China, 200120
Actively Recruiting
38
Shanghai GoBroad Cancer Hospital
Shanghai, China, 200131
Not Yet Recruiting
39
Wuhan Union Hospital
Wuhan, China, 430022
Not Yet Recruiting
40
Henan Cancer Hospital
Zhengzhou, China, 450008
Actively Recruiting
41
INS Bergonie
Bordeaux, France, 33000
Actively Recruiting
42
CTR Georges-François Leclerc
Dijon, France, 21079
Actively Recruiting
43
CTR Leon Berard
Lyon, France, 69373
Not Yet Recruiting
44
HOP Timone
Marseille, France, 13385
Not Yet Recruiting
45
HOP la Milétrie
Poitiers, France, 86000
Actively Recruiting
46
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
47
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Not Yet Recruiting
48
Justus-Liebig Universität Gießen
Giessen, Germany, 35392
Actively Recruiting
49
Asklepios Kliniken GmbH & Co. KGaA
Hamburg, Germany, 22763
Actively Recruiting
50
Universität Leipzig
Leipzig, Germany, 04103
Actively Recruiting
51
Universitätsklinikum Mannheim GmbH
Mannheim, Germany, 68167
Actively Recruiting
52
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Not Yet Recruiting
53
Az. Ospedaliere Umberto I di Ancona
Ancona, Italy, 60020
Actively Recruiting
54
Centro di riferimento Oncologico
Aviano (PN), Italy, 33081
Not Yet Recruiting
55
Istituto Scientifico Romagnolo
Meldola (FC), Italy, 47014
Actively Recruiting
56
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
57
AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy, 80131
Actively Recruiting
58
Fondazione Policlinico Universitario Campus Bio-medico
Rome, Italy, 00128
Not Yet Recruiting
59
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan, 464-8681
Actively Recruiting
60
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Actively Recruiting
61
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Not Yet Recruiting
62
Hokkaido University Hospital
Hokkaido, Sapporo, Japan, 060-8648
Not Yet Recruiting
63
Okayama University Hospital
Okayama, Okayama, Japan, 700-8558
Not Yet Recruiting
64
Osaka International Cancer Institute
Osaka, Osaka, Japan, 541-8567
Actively Recruiting
65
Shizuoka Cancer Center
Shizuoka, Sunto-gun, Japan, 411-8777
Actively Recruiting
66
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan, 104-0045
Actively Recruiting
67
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Actively Recruiting
68
Nederlands Kanker Instituut
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
69
Radboud Universitair Medisch Centrum
Nijmegen, Netherlands, 6525 GL
Actively Recruiting
70
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, Norway, N-0379
Actively Recruiting
71
Pan American Center for Oncology Trials, LLC
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
72
National Cancer Centre Singapore
Singapore, Singapore, 168583
Not Yet Recruiting
73
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
74
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
75
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
76
Samsung Medical Center
Seoul, South Korea, 135-710
Actively Recruiting
77
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Actively Recruiting
78
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Not Yet Recruiting
79
Hospital del Mar
Barcelona, Spain, 08003
Actively Recruiting
80
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
81
Hospital Duran i Reynals
Barcelona, Spain, 08908
Not Yet Recruiting
82
Clínica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Actively Recruiting
83
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
84
Clínica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
85
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
86
Hospital Clinico De Valencia (INCLIVA)
Valencia, Spain, 46010
Not Yet Recruiting
87
Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Not Yet Recruiting
88
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
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Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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