Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
NCT Number: NCT06581432
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Solid Tumours
Interventions: DRUG: Zongertinib
Sponsor: Boehringer Ingelheim
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-16
Completion Date: 2027-09-30

Summary:
This is a study for people with advanced cancer for whom previous treatment was not successful or no treatment exists. 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 10 groups based on the type of advanced cancer and the type of HER2 alterations they have. All participants take one dose of zongertinib. 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.

Primary Outcome Measures: Proportion of patients with objective response (OR), Objective response (OR) is defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as assessed by central independent review, from the date of treatment start until the earliest date of progressive disease (PD), death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or trial treatment discontinuation., Up to 37 months
Secondary Outcome Measures: Duration of objective response (DOR), Duration of objective response (DOR) is defined as the time from first documented confirmed Objective response (OR) according to RECIST 1.1 until the earliest date of disease progression or death among patients with confirmed OR, assessed by central independent review., Up to 37 months|Progression-Free Survival (PFS), PFS is defined as the time from treatment start until the earliest date of tumour progression according to RECIST 1.1 assessed by central independent review, or death from any cause, whichever occurs first., Up to 37 months|Disease control (DC), Disease control (DC) is defined as best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) where BOR is defined according to RECIST 1.1 from first treatment administration until the earliest of disease progression, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, or treatment discontinuation, as assessed by central independent review., Up to 37 months|Occurrence of treatment-emergent Adverse Events (AEs), Up to 37 months|Change from baseline to Week 48 or progressive disease (PD) by central independent review, if earlier, in the European Organisation for Research and Treatment of Cancer, item list (EORTC IL19), The EORTC IL19 consists of five physical functioning scale items. It is rated on a scale from 1 to 4, ranging from "not at all" to "very much"., At baseline and up to 48 weeks