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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

588 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
• 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (93)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

93 locations

Study team and timeline

Lead sponsor

Boehringer Ingelheim

Study start

Oct 11, 2024 Actual

Primary completion

Nov 30, 2028 Estimated

Study completion

Dec 29, 2028 Estimated

First posted

Sep 3, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts