1479-0009
Research type
Research Study
Full title
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
IRAS ID
1013453
Contact name
Medical Information
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Clinicaltrials.gov Identifier
Research summary
Beamion PANTUMOR-1 study tests whether zongertinib helps people with advanced cancers with HER2 alterations. HER2 is a gene involved in cell growth; when altered, it can cause abnormal growth leading to cancer. Zongertinib inhibits HER2. The goal is to find out whether zongertinib reduces the tumour size and whether it is tolerated. The main endpoint is objective response (OR), which measures if tumours shrink or disappear from treatment start until progression, death, new therapy, or treatment discontinuation. Secondary endpoints include duration of OR, progression-free survival, disease control, overall survival, health problems during treatment, and change from baseline to week 48 or progression in the EORTC QLQ-C30 quality-of-life questionnaire. This is a multinational, open-label, multicentre, multicohort study. Participants may remain in the study if they benefit and tolerate treatment. Adults aged 18+ with advanced cancer with HER2 alterations may join if at least one prior treatment was unsuccessful. Participants are assigned to 1 of 13 cohorts based on cancer type and HER2 alteration. Eight cohorts include HER2-overexpressed/amplified cancers (e.g., urothelial, biliary tract, uterine, cervical, NSCLC, salivary gland, colorectal, and any other tumour types except breast). Five cohorts include HER2-mutant cancers (e.g., urothelial, breast, gastric/oesophageal adenocarcinoma, biliary tract, and other tumour types except NSCLC). All take one daily dose of zongertinib and continue while benefiting and tolerating treatment. Tumours are regularly imaged, and health information is collected. Participants may not personally benefit, but their involvement may help future patients. Possible benefits include tumour reduction or disease stabilisation. Risks include effects on the liver, mouth, gastrointestinal system, immune system, skin, reproduction, development, and possible hair discolouration. Safety is closely monitored, and doses are based on previous safe use.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0038
Date of REC Opinion
14 Apr 2026
REC opinion
Further Information Favourable Opinion