RECRUITING

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

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Conditions

Solid Tumours

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-11
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06581432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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).
  3. * Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
  4. * HER2 overexpression/amplification
  5. * Known activating HER2 mutations
  6. * 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.
  7. * 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.
  1. * Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
  2. * Previous or concomitant malignancies other than the 1 treated in this trial within the previous 3 years except:
  3. * effectively treated non-melanoma skin cancers
  4. * effectively treated carcinoma in situ of the cervix
  5. * effectively treated ductal carcinoma in situ of the breast
  6. * localised prostate cancer on watchful waiting or active surveillance
  7. * other effectively treated malignancy that is considered cured by local treatment.
  8. * 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
  9. * 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.

Contacts and Locations

Study Contact

Boehringer Ingelheim
CONTACT
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Study Locations (Sites)

Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508
United States
Scripps Cancer Center Torrey Pines
La Jolla, California, 92037
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
BRCR Global
Tamarac, Florida, 33321
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
VCU Health Community Memorial Hospital
South Hill, Virginia, 23970
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2024-10-11
Study Completion Date2027-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Solid Tumours