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 (1479-0009)

Studio Clinico

Patologia: Neoplasie della mammella, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. 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.
2. 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).
3. Documented (previously established by local testing) Human epidermal growth factor receptor 2 (HER2) status of:
    - HER2 overexpression/amplification
    - Known activating HER2 mutations
4. 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.
5. Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease.

Criteri di esclusione: 

1. Diagnosis of HER2 mutant Non-small cell lung cancer (NSCLC)
2. 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
    - other effectively treated malignancy that is considered cured by local treatment
3. 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
4. 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.

Trattamento sperimentale: 

BI 1810631

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-510429-14-00

Data di inserimento: 03.03.2025

Promotore

Boehringer Ingelheim

CRO

IQVIA

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na