Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Boehringer Ingelheim (Voir sur ClinicalTrials)
octobre 2024
décembre 2028
29 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 24/07/2026 07:10:04 | Contacter | ||
Critères
Tous
- 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.