Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread - 1479-0012

Studio Clinico

Patologia: Neoplasie della mammella, Neoplasie dello stomaco, Tumori dell’esofago

Osservazionale-Sperimentale: Sperimentale

Randomizzato: Sì

Fase di studio: 1, II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

1. Signed and dated written Informed consent form (ICF) 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 of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
3. Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).
4. For dose optimization (Phase II): Patient must provide tumor tissue from locations not radiated prior to biopsy, if possible, collected through archival tissue.
5. Documented investigator assessed progression.
6. Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy, and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2).
7. Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1. Further inclusion criteria apply.

Criteri di esclusione: 

1. Previous or concomitant malignancies other than the one treated in this trial within the previous 2 years, which require current systemic therapy 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
2. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction (or troponin levels consistent with myocardial infarction within 28 days of randomization), stroke, or pulmonary embolism within 6 months prior to randomization.
3. Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
4. Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) >470 msec.
5. Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age. Or any concomitant medication known to prolong the QT interval.
6. Ejection fraction <50% or the lower limit of normal of the institutional standard within 28 days prior to randomization.
7. Women who are pregnant, nursing, or who plan to become pregnant or nurse during the trial or within 7 months after the last dose of trial treatment with T-DXd or T-DM1.

Trattamento sperimentale: 

BI 1810631

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-509566-38-00

Data di inserimento: 15.11.2024

Promotore

Boehringer Ingelheim

CRO

IQVIA

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na