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A Phase 2b, Open-label, Single-arm Study of ZW25 Monotherapy in Subjects With Advanced or Metastatic HER2-amplified Biliary Tract Cancers - ZWI-ZW25-203

Studio Clinico

Patologia: Tumori delle vie biliari

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- Histologically - or cytologically - confirmed BTC, including ICC, ECC or GBC.
- Locally advanced or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
- Received at least 1 prior regimen of systemic therapy for advanced disease, including 1 gemcitabine-containing regimen, and experienced disease progression after or developed intolerance to the most recent prior therapy. For subjects who have received prior adjuvant or neoadjuvant treatment, if progression has occurred < 6 months from completion of the adjuvant or neoadjuvant therapy, this regimen will be considered as 1 prior line of therapy for advanced disease.
- Subjects must test positive for HER2 amplification by ISH-assay at a central laboratory on a new biopsy or archival tissue. Note that fine needle aspirates (FNAs; cytology samples) and biopsies from sites of bone metastases are not acceptable. Testing may occur at any time after diagnosis of advanced or metastatic disease and before study enrollment.
- Male or female, ≥18 years of age (or the legal age of adulthood per country-specific regulations).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Adequate organ function.
- Adequate cardiac function, as defined by left ventricular ejection fraction ≥ 50%.

Criteri di esclusione: 

- Received systemic anti-cancer therapy within 3 weeks of the first dose of ZW25. Received radiotherapy within 2 weeks of the first dose of ZW25.
- Prior treatment with HER2-targeted agents.
- Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as subjects who are off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks at the time of screening).
- Known leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline MRI, but is not suspected clinically by the investigator, the subject must be free of neurological symptoms of LMD.
- Concurrent uncontrolled or active hepatobiliary disorders or untreated or ongoing complications after laparoscopic procedures or stent placement, including but not limited to active cholangitis, unresolved biliary obstruction, biloma or abscess. Any complications should be resolved within 2 weeks prior to the first dose of ZW25.
- Prior or concurrent invasive malignancy whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.
- Active hepatitis
- Infection with human immunodeficiency virus (HIV)-1 or HIV-2
- QTc Fridericia (QTcF) > 470 ms.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease.
- Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease.

Trattamento sperimentale: 

ZW25 (Zanidatamab) Monotherapy

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or metastatic biliary tract cancer (BTC), including intra-hepatic cholangiocarcinoma (ICC), extra-hepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC).

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

Riferimento: Prof. Filippo De Braud
Telefono: 0223902148
Email: filippo.debraud@istitutotumori.mi.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof.ssa Lorenza Rimassa
Telefono: 0282244573
Email: lorenza.rimassa@hunimed.eu

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

Riferimento: Dr.ssa Sara Lonardi
Telefono: 0498215910
Email: sara.lonardi@iov.veneto.it

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

Riferimento: Dr.ssa Elisabetta Fenocchio
Telefono: 0119933250
Email: elisabetta.fenocchio@ircc.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-000459-11

Data di inserimento: 05.08.2021

Promotore

Zymeworks Inc.

CRO

Fondazione IRCCS 'Istituto Nazionale dei Tumori', Milano

Principal Investigator ITALIA

Fondazione IRCCS 'Istituto Nazionale dei Tumori', Milano

Riferimento: Prof. Filippo De Braud

Telefono: 0223902148

Email: filippo.debraud@istitutotumori.mi.it

Localita: Milano

 

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