CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 430 target
Drug / intervention
Zongertinibdrug
Likely dose
Not stated in record
Key inclusion· 7
  • Age ≥18 years or legal age of consent if higher
  • Documented HER2 amplification or known activating HER2 mutations
  • Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour
  • At least one prior line of therapy for metastatic disease
Key exclusion· 4
  • HER2 mutant Non-small cell lung cancer (NSCLC)
  • Prior malignancy within 3 years except non-melanoma skin cancer, cervical CIS, breast DCIS, localised prostate cancer on surveillance, or other effectively treated cured malignancy
  • Use of restricted medications or drugs likely to interfere with safe conduct of trial
  • Not completely recovered from major surgery performed prior to screening or planned within 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06581432
NCT06581432Phase 2RecruitingOn Track

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

Boehringer Ingelheim·interventional·Posted Sep 3, 2024·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating Zongertinib for Solid Tumours. Currently recruiting, targeting 430 participants across 88 sites in 16 countries.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumours
CountriesAustralia, Belgium, Canada, China, France, Germany, Italy, Japan, Netherlands, Norway, Puerto Rico, Singapore, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
20252026202720282029
First PostedSep 3, 2024
Enrollment StartOct 11, 2024
Primary CompletionDec 31, 2027
Study CompletionDec 29, 2028
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 1.8 years agoPrimary completion in 1.5 years

Arms & Interventions

Zongertinib treatmentexperimental

Drug: Zongertinib

Interventions

Zongertinibdrug

Zongertinib