NCT06581432

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 430 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
DRUG	Zongertinib	Zongertinib

Timeline

• Start date: 2024-10-11
• Primary completion: 2027-12-31
• Completion: 2028-12-29
• First posted: 2024-09-03
• Last updated: 2026-04-17

Locations

84 sites across 16 countries: United States, Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Netherlands, Norway, Puerto Rico, Singapore, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study