RECRUITING

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

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.

Conditions

Solid Tumours
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Related Conditions:

Solid Tumours

Study Overview

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Study Details

Study 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 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.

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

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

Condition
Solid Tumours
Intervention / Treatment

-

Contacts and Locations

Anchorage

Alaska Oncology and Hematology, LLC, Anchorage, Alaska, United States, 99508

La Jolla

Scripps Cancer Center Torrey Pines, La Jolla, California, United States, 92037

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Los Angeles

University of California Los Angeles, Los Angeles, California, United States, 90095

Tamarac

BRCR Global, Tamarac, Florida, United States, 33321

New York

Memorial Sloan-Kettering Cancer Center, New York, New York, United States, 10065

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Fairfax

Virginia Cancer Specialists, PC, Fairfax, Virginia, United States, 22031

South Hill

VCU Health Community Memorial Hospital, South Hill, Virginia, United States, 23970

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boehringer Ingelheim,

Study Record Dates

2027-09-30