Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations

Official title

Beamion PANTUMOR-1: A Phase II, Multicentre, Multicohort, Open-label Trial to Evaluate the Efficacy and Safety of Oral Zongertinib (BI 1810631) for the Treatment of Selected HER2-mutated or Overexpressed/Amplified Solid Tumours

Overview

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 groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses 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.

Interventions

• Drug Zongertinib
  Zongertinib

Primary outcome measures

• Proportion of patients with objective response (OR) [Time frame: Up to 51 months]

Secondary outcome measures (6)

• Duration of objective response (DOR) [Time frame: Up to 51 months]
• Progression-Free Survival (PFS) [Time frame: Up to 51 months]
• Disease control (DC) [Time frame: Up to 51 months]
• Occurrence of treatment-emergent Adverse Events (AEs) [Time frame: Up to 51 months]
• Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, of the EORTC QLQ-C30, which includes IL-19, the physical functioning scale [Time frame: At baseline and up to 48 weeks]
• Overall survival (OS) [Time frame: Up to 51 months]

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 amplification
• Known activating HER2 mutations
• Availability and willingness to provide a sample of archival formalin-fixed paraffin embedded (FFPE) tumour tissue material
• Patient with histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour who has had at least one prior line of therapy for metastatic disease. In the opinion of the Investigator, patients must be unlikely to tolerate or derive clinically meaningful benefit from further standard of care therapy known to prolong survival.

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 of the breast
• localised prostate cancer on watchful waiting or active surveillance
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 20 centers

• Alaska Oncology and Hematology, LLC — Anchorage
• University of Arizona Comprehensive Cancer Center — Tucson
• Precision NextGen Oncology — Beverly Hills
• Scripps Cancer Center Torrey Pines — La Jolla
• Valkyrie Clinical Trials — Los Angeles
• Yale University School of Medicine — New Haven
• BRCR Global — Tamarac
• Illinois Cancer Specialists — Arlington Heights
• … and 12 more centers

Spain · 10 centers

• Complejo Hospitalario Universitario A Coruña — A Coruña
• Hospital Germans Trias i Pujol — Badalona
• Hospital del Mar — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• … and 6 more centers

Japan · 9 centers

• Aichi Cancer Center Hospital — Aichi, Nagoya
• National Cancer Center Hospital East — Chiba, Kashiwa
• Kyushu University Hospital — Fukuoka, Fukuoka
• Hokkaido University Hospital — Hokkaido, Sapporo
• Okayama University Hospital — Okayama, Okayama
• Osaka International Cancer Institute — Osaka, Osaka
• Shizuoka Cancer Center — Shizuoka, Sunto-gun
• National Cancer Center Hospital — Tokyo, Chuo-ku
• … and 1 more center

China · 8 centers

• Peking University First Hospital — Beijing
• Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Hangzhou
• Anhui Provincial Cancer Hospital — Hefei
• The First Affiliated Hospital of Nanchang University — Nanchang
• Shanghai East Hospital — Shanghai
• Shanghai GoBroad Cancer Hospital — Shanghai
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
• Henan Cancer Hospital — Zhengzhou

France · 6 centers

• INS Bergonie — Bordeaux
• CTR Georges-François Leclerc — Dijon
• CTR Leon Berard — Lyon
• HOP Timone — Marseille
• HOP la Milétrie — Poitiers
• Institut Gustave Roussy — Villejuif

Germany · 6 centers

• Charité - Universitätsmedizin Berlin — Berlin
• Justus-Liebig Universität Gießen — Giessen
• Asklepios Kliniken GmbH & Co. KGaA — Hamburg
• Universität Leipzig — Leipzig
• Universitätsklinikum Mannheim GmbH — Mannheim
• Klinikum rechts der Isar der Technischen Universität München — München

Italy · 6 centers

• Az. Ospedaliere Umberto I di Ancona — Ancona
• Centro di riferimento Oncologico — Aviano (PN)
• Istituto Scientifico Romagnolo — Meldola (FC)
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• AOU Università degli Studi della Campania Luigi Vanvitelli — Naples
• Fondazione Policlinico Universitario Campus Bio-medico — Rome

Australia · 5 centers

• Macquarie University — Macquarie Park
• GenesisCare North Shore — St Leonards
• Princess Alexandra Hospital — Woolloongabba
• Cancer Research South Australia — Adelaide
• St John of God Subiaco Hospital — Subiaco

Canada · 5 centers

• Cross Cancer Institute (University of Alberta) — Edmonton
• BC Cancer Agency - Vancouver — Vancouver
• Princess Margaret Cancer Centre — Toronto
• Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal
• McGill University Health Centre (MUHC) — Montreal

South Korea · 4 centers

• Seoul National University Hospital — Seoul
• Severance Hospital — Seoul
• Asan Medical Center — Seoul
• Samsung Medical Center — Seoul

United Kingdom · 3 centers

Center list to be confirmed — check the primary protocol.

Belgium · 2 centers

• Cliniques Universitaires Saint-Luc — Brussels
• Universitair Ziekenhuis Antwerpen — Edegem

Netherlands · 2 centers

• Nederlands Kanker Instituut — Amsterdam
• Radboud Universitair Medisch Centrum — Nijmegen

Norway · 1 center

• Oslo Universitetssykehus HF, Radiumhospitalet — Oslo

Puerto Rico · 1 center

• Pan American Center for Oncology Trials, LLC — Rio Piedras

Singapore · 1 center

• National Cancer Centre Singapore — Singapore

Publications

• Schram AM, Park JJ, Italiano A, Kitano S, Guo Y, Li J, Bedard PL, van Marcke C, Ko R, Lunger L, Klotz DM, Hussain J, Maier D, Erzen D, Planchard D, Prenen H, Clay TD, Park JO, Kim HD, Hernando-Calvo A, Maruki Y, Ponz-Sarvise M, Dumbrava E. Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors. Future Oncol. 2026 Mar; PMID 41777164

Identifiers

NCT: NCT06581432 · 1479-0009 · 2023-510429-14-00 · U1111-1302-3333

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗