Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2- Expressing Gastrointestinal (GI) Cancers, Including Gastroesophageal Adenocarcinoma (GEA), Biliary Tract Cancer (BTC), and Colorectal Cancer (CRC)
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus physician's choice of combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA). Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA.
To characterize the safety and tolerability of ZW25 when administered with combination chemotherapy in subjects receiving first-line treatment for human epidermal growth factor receptor 2 (HER2)- expressing GEA, BTC, or CRC (physician fs choice of XELOX, FP, mFOLFOX6 for subjects with GEA CisGem for subjects with BTC; and mFOLFOX6 with or without bevacizumab for subjects with CRC)
To establish the recommended dose (RD) of ZW25 when administered with combination chemotherapy
- To evaluate anti-tumor activity of ZW25 when administered with physician's choice of combination chemotherapy in patients receiving first-line treatment for HER2-expressing GEA, BTC, or CRC
- To characterize the immunogenicity of ZW25 when administered in combination with physician's choice of first-line combination chemotherapy
- To evaluate the PK of ZW25 when administered in combination with physician's choice of first-line combination chemotherapy
Treatment for GEA with prior anti-cancer therapy (including investigational products) except prior adjuvant/neoadjuvant therapy, which must be completed at least 6 months prior to first study treatment dosing. Palliative radiotherapy is allowed if completed at least 2 weeks prior to first study treatment dosing.
Untreated known brain metastases (patients with treated brain metastases who are off steroids, off anti-seizure medications, and stable for at least 1 month at the time of screening are eligible)
Having clinically significant cardiac disease or known myocardial infarction or unstable angina (within 6 months before first study treatment dosing)
QTc Fridericia (QTcF) > 470 ms for females and > 450 ms for males
Peripheral neuropathy > Grade 1 per NCI-CTCAE v5.0
Clinically significant interstitial lung disease
Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Active hepatitis B or hepatitis C infection or other known chronic liver disease or infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2 (Exception: patients with well controlled HIV [e.g., CD4 > 350/mm3 and undetectable viral load] are eligible.)
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