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New treatment option for Solid Tumours
Official title Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
ClinicalTrials.gov ID: NCT06581432
What this study is testing
What is Zongertinib?
Zongertinib is an investigational medicine, being studied as a potential treatment for solid tumours.
Also referred to as BI 1810631, Hernexeos®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local...
- 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...
- Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
- HER2 amplification
- Known activating HER2 mutations
You likely can't join if
- 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
See the full 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 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Tamarac, Florida, United States
- Arlington Heights, Illinois, United States
- Indianapolis, Indiana, United States
- Columbia, Maryland, United States
- Detroit, Michigan, United States
- Albuquerque, New Mexico, United States
- New York, New York, United States
- Maumee, Ohio, United States
- Wynnewood, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Plano, Texas, United States
- Fairfax, Virginia, United States
- Macquarie Park, New South Wales, Australia
+ 61 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; Tucson, Arizona, United States; Beverly Hills, California, United States; La Jolla, California, United States; Los Angeles, California, United States; New Haven, Connecticut, United States and 75 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.