Zanidatamab + Chemotherapy for Gastrointestinal Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
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 standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain cancer treatments or have specific health conditions, you may not be eligible to participate.
What is the safety profile of Zanidatamab and chemotherapy for gastrointestinal cancers?
Bevacizumab, a drug often used in combination with chemotherapy, has a safety profile that includes mild to moderate side effects like high blood pressure, protein in urine, and minor bleeding, which are generally manageable. More serious side effects like wound healing issues, gastrointestinal perforations, and arterial thrombosis are less common. This makes it a suitable addition to chemotherapy in cases where it has been shown to be effective.12345
What makes the drug Zanidatamab + Chemotherapy unique for gastrointestinal cancers?
Zanidatamab, combined with chemotherapy, is unique because it targets specific proteins on cancer cells, potentially enhancing the effectiveness of traditional chemotherapy drugs like 5-FU, cisplatin, and oxaliplatin. This combination aims to improve outcomes in gastrointestinal cancers, where no standard chemotherapy regimen has been established.678910
What data supports the effectiveness of the drug combination Zanidatamab + Chemotherapy for gastrointestinal cancers?
Research shows that combining drugs like cisplatin and 5-fluorouracil (5-FU) with other agents can improve survival in gastric cancer patients. Capecitabine, a form of 5-FU, has been effective in combination with cisplatin and other drugs, offering a convenient oral option with similar effectiveness to intravenous 5-FU.611121314
Who Is on the Research Team?
Phillip Garfin, MD, PhD
Principal Investigator
Jazz Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for adults with advanced HER2-expressing gastrointestinal cancers, including gastroesophageal adenocarcinoma, biliary tract cancer, and colorectal cancer that can't be removed by surgery. Participants should have an ECOG score of 0 or 1 (which means they are fully active or restricted in physically strenuous activity but can do light work), no prior treatment with HER2-targeted agents, and no significant heart disease or untreated brain metastases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ZW25 plus standard first-line combination chemotherapy regimens for selected gastrointestinal cancers
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Capecitabine
- Cisplatin
- Fluorouracil
- Gemcitabine
- Leucovorin
- Oxaliplatin
- ZW25 (Zanidatamab)
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Zymeworks Inc.
Lead Sponsor
Jazz Pharmaceuticals
Lead Sponsor
Bruce C. Cozadd
Jazz Pharmaceuticals
Chief Executive Officer since 2009
BA in Economics from Yale University, MBA from Stanford University
Dr. Austin
Jazz Pharmaceuticals
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland