Clinical trial NCT06581432: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Solid Tumours
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Proportion of patients with objective response (OR)
timeFrame: Up to 37 months
Secondary outcomes:
measure: Duration of objective response (DOR)
timeFrame: Up to 37 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 37 months
measure: Disease control (DC)
timeFrame: Up to 37 months
measure: Occurrence of treatment-emergent Adverse Events (AEs)
timeFrame: Up to 37 months
measure: 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)
timeFrame: At baseline and up to 48 weeks
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology, LLC
state: Alaska
city: Tucson
country: United States
facility: University of Arizona Comprehensive Cancer Center
state: Arizona
city: Beverly Hills
country: United States
facility: Precision NextGen Oncology
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center Torrey Pines
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tamarac
country: United States
facility: BRCR Global
state: Florida
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Indianapolis
country: United States
facility: Community MD Anderson Cancer Center - East Medical Oncology
state: Indiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology, Columbia
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Wynnewood
country: United States
facility: Alliance Cancer Specialists, PC, Wynnewood
state: Pennsylvania
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
city: Bruxelles
country: Belgium
facility: Brussels - UNIV Saint-Luc
city: Edegem
country: Belgium
facility: Edegem - UNIV UZ Antwerpen
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Bordeaux
country: France
facility: INS Bergonie
city: Dijon
country: France
facility: CTR Georges-François Leclerc
city: Poitiers
country: France
facility: HOP la Milétrie
city: Villejuif
country: France
facility: INS Gustave Roussy
city: Gießen
country: Germany
facility: Justus-Liebig Universität Gießen
city: Hamburg
country: Germany
facility: Asklepios Kliniken GmbH & Co. KGaA
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim GmbH
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Ancona
country: Italy
facility: Az. Ospedaliere Umberto I di Ancona
city: Meldola (fc)
country: Italy
facility: Istituto Scientifico Romagnolo
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: AOU Università degli Studi della Campania Luigi Vanvitelli
city: Aichi, Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Chiba, Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Osaka, Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Shizuoka, Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo, Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Tokyo, Koto-ku
country: Japan
facility: Japanese Foundation for Cancer Research
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF, Radiumhospitalet
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials, LLC
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Clínica Universidad de Navarra - Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
Study officials:
References: