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Clinical Trials in the UK / NCT06581432
Recruiting Phase 2

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

NCT06581432 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 2
Started
2024-10-11
Last updated
2026-09-15

Condition(s) studied

Solid Tumours

Investigational drug(s) / intervention(s)

Zongertinib

Zongertinib: Zongertinib

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion criteria: * Patients aged ≥18 years * Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing) * Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours * Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options * Availability of archival tumour tissue sample to confirm HER2 status * Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply. Exclusion criteria: * Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer or metastatic gastroesophageal adenocarcinoma * Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC) * Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs) * Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment * Uncontrolled or symptomatic brain or subdural metastases during screening * Known diagnosis of leptomeningeal disease * Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.

Primary outcome measure(s)

Trial sites (92)

FacilityCityRegionStatus
Alaska Oncology and Hematology, LLC Anchorage Alaska Recruiting
University of Arizona Comprehensive Cancer Center Tucson Arizona Completed
Precision NextGen Oncology Beverly Hills California Recruiting
Scripps Cancer Center Torrey Pines La Jolla California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
BRCR Global Tamarac Florida Recruiting
Illinois Cancer Specialists Arlington Heights Illinois Recruiting
Community MD Anderson Cancer Center - East Medical Oncology Indianapolis Indiana Recruiting
Maryland Oncology Hematology, Columbia Columbia Maryland Recruiting
Karmanos Cancer Institute Detroit Michigan Completed
Presbyterian Healthcare Services Albuquerque New Mexico Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Memorial Sloan-Kettering Cancer Center New York New York Recruiting
Taylor Cancer Research Center Maumee Ohio Recruiting
Alliance Cancer Specialists, PC, Wynnewood Wynnewood Pennsylvania Recruiting
Sarah Cannon Research Institute at Mary Crowley Dallas Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - Plano West Plano Texas Recruiting
Virginia Cancer Specialists, PC Fairfax Virginia Recruiting
Macquarie University Macquarie Park New South Wales Recruiting
GenesisCare North Shore St Leonards New South Wales Recruiting
Princess Alexandra Hospital Woolloongabba Queensland Recruiting
Cancer Research South Australia Adelaide South Australia Recruiting
St John of God Subiaco Hospital Subiaco Western Australia Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Recruiting
Cross Cancer Institute (University of Alberta) Edmonton Alberta Recruiting
BC Cancer Agency - Vancouver Vancouver British Columbia Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM) Montreal Quebec Recruiting
McGill University Health Centre (MUHC) Montreal Quebec Completed
Peking University First Hospital Beijing China Recruiting
Hunan Province Tumor Hospital Changsha China Not Yet Recruiting
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou China Recruiting
Anhui Provincial Cancer Hospital Hefei China Recruiting
The First Affiliated Hospital of Nanchang University Nanchang China Recruiting
Nanjing Drum Tower Hospital Nanjing China Not Yet Recruiting
Shanghai East Hospital Shanghai China Recruiting
Shanghai GoBroad Cancer Hospital Shanghai China Recruiting

+ 52 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06581432 on ClinicalTrials.gov ↗ ← All trials in the UK