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
novembre 2028
23 juillet 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CTR Georges-François Leclerc - 21079 - Dijon - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP la Milétrie - 86000 - Poitiers - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| INS Bergonie - 33000 - Bordeaux - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
Critères
Tous
inclusion criteria:
- Signed and dated written informed consent in accordance with International Council
for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial.
- Patients ≥18 years old or over the legal age of consent in countries where that is
greater than 18 years at the time of signature of the Informed consent form (ICF).
- Documented (previously established by local testing) Human epidermal growth factor
receptor 2 (HER2) status of:
- HER2 overexpression/amplification
- Known activating HER2 mutations
- An archival (enrolment) tumour tissue sample must be submitted after inclusion of
the patient to retrospectively confirm the HER2 status (enrolment tissue sample). If
no archival tissue is available, this may be acceptable in exceptional cases after
written agreement with the sponsor. Please note that sample must not be from an area
irradiated prior to the biopsy.
- Patient with histologically or cytologically confirmed locally advanced unresectable
or metastatic solid tumour who has had at least one prior line of therapy for
metastatic disease. In the opinion of the Investigator, patients must be unlikely to
tolerate or derive clinically meaningful benefit from further standard of care
therapy known to prolong survival.
Further inclusion criteria apply.
- Signed and dated written informed consent in accordance with International Council
for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to
admission to the trial.
- Patients ≥18 years old or over the legal age of consent in countries where that is
greater than 18 years at the time of signature of the Informed consent form (ICF).
- Documented (previously established by local testing) Human epidermal growth factor
receptor 2 (HER2) status of:
- HER2 overexpression/amplification
- Known activating HER2 mutations
- An archival (enrolment) tumour tissue sample must be submitted after inclusion of
the patient to retrospectively confirm the HER2 status (enrolment tissue sample). If
no archival tissue is available, this may be acceptable in exceptional cases after
written agreement with the sponsor. Please note that sample must not be from an area
irradiated prior to the biopsy.
- Patient with histologically or cytologically confirmed locally advanced unresectable
or metastatic solid tumour who has had at least one prior line of therapy for
metastatic disease. In the opinion of the Investigator, patients must be unlikely to
tolerate or derive clinically meaningful benefit from further standard of care
therapy known to prolong survival.
Further inclusion criteria apply.
- Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
- Previous or concomitant malignancies other than the 1 treated in this trial within
the previous 3 years except:
- effectively treated non-melanoma skin cancers
- effectively treated carcinoma in situ of the cervix
- effectively treated ductal carcinoma in situ of the breast
- localised prostate cancer on watchful waiting or active surveillance
- other effectively treated malignancy that is considered cured by local
treatment.
- Patients who must or wish to continue the intake of restricted medications or any
drug considered likely to interfere with the safe conduct of the trial
- Not completely recovered from major surgery (major according to the investigator's
assessment) performed prior to screening or planned within 6 months after screening,
e.g. hip replacement Further exclusion criteria apply.