74 Participants Needed

Zanidatamab + Chemotherapy for Gastrointestinal Cancers

Recruiting at 25 trial locations
ZC
CT
Overseen ByClinical Trial Disclosure & Transparency
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

PG

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

My condition meets the criteria outlined in Part 1.
My bile duct cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.
My heart's left ventricle is functioning well.
See 12 more

Exclusion Criteria

I have been treated with a HER2-targeted therapy before.
I haven't had cancer treatment recently, except for early-stage therapy over 6 months ago.
I have treated brain metastases and have been stable without steroids or seizure meds for 1 month.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ZW25 plus standard first-line combination chemotherapy regimens for selected gastrointestinal cancers

Up to 11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Capecitabine
  • Cisplatin
  • Fluorouracil
  • Gemcitabine
  • Leucovorin
  • Oxaliplatin
  • ZW25 (Zanidatamab)
Trial Overview The study tests ZW25 (zanidatamab) combined with standard chemotherapy to see how safe it is and how well it works against certain gastrointestinal cancers. It's a Phase 2 trial where all participants receive the experimental drug plus one of several chemo regimens like Fluorouracil/Leucovorin with Bevacizumab or Gemcitabine/Cisplatin.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: ZW25 + mFOLFOX6 with bevacizumabExperimental Treatment5 Interventions
ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab
Group II: ZW25 + mFOLFOX6Experimental Treatment4 Interventions
ZW25 plus 5-FU, leucovorin, and oxaliplatin
Group III: ZW25 + XELOXExperimental Treatment3 Interventions
ZW25 plus capecitabine and oxaliplatin
Group IV: ZW25 + FPExperimental Treatment3 Interventions
ZW25 plus fluorouracil (5-FU) and cisplatin
Group V: ZW25 + CisGemExperimental Treatment2 Interventions
ZW25 plus cisplatin and gemcitabine

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

🇪🇺
Approved in European Union as Avastin for:
  • Colorectal cancer
  • Breast cancer
  • Non-small cell lung cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇺🇸
Approved in United States as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Glioblastoma
  • Renal cell carcinoma
  • Cervical cancer
  • Ovarian cancer
🇯🇵
Approved in Japan as Avastin for:
  • Colorectal cancer
  • Non-small cell lung cancer
  • Breast cancer
  • Renal cell carcinoma
  • Ovarian cancer
🇨🇦
Approved in Canada as Avastin for:
  • 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

Trials
11
Recruited
2,400+

Jazz Pharmaceuticals

Lead Sponsor

Trials
252
Recruited
35,100+
Bruce C. Cozadd profile image

Bruce C. Cozadd

Jazz Pharmaceuticals

Chief Executive Officer since 2009

BA in Economics from Yale University, MBA from Stanford University

Dr. Austin profile image

Dr. Austin

Jazz Pharmaceuticals

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

Bevacizumab (Avastin) effectively targets VEGF to inhibit tumor angiogenesis, showing a safety profile that includes mostly mild to moderate side effects such as hypertension and proteinuria, which are manageable in clinical settings.
The side effects associated with bevacizumab, including rare but serious events like gastrointestinal perforation and arterial thrombosis, do not typically exacerbate the toxicity of standard chemotherapy, making it a suitable adjunct treatment for metastatic colorectal cancer.
Managing patients treated with bevacizumab combination therapy.Gordon, MS., Cunningham, D.[2015]
A study of 27 cancer patients with inflammatory bowel disease (IBD) showed that combining bevacizumab with chemotherapy is safe, with no observed clinical flares of IBD during treatment.
Despite some patients experiencing grade 2 or higher complications like proteinuria and hypertension, the overall safety profile suggests that bevacizumab can be effectively used in patients with either quiescent or moderately active IBD.
Safety and Efficacy of Bevacizumab in Cancer Patients with Inflammatory Bowel Disease.Herrera-Gómez, RG., Grecea, M., Gallois, C., et al.[2022]
In a study of 1,401 patients with metastatic colorectal cancer, adding bevacizumab to first-line oxaliplatin-based chemotherapy significantly improved progression-free survival (PFS) from 8.0 months to 9.4 months compared to placebo.
While overall survival was longer in the bevacizumab group (21.3 months vs. 19.9 months), this difference was not statistically significant, indicating that while bevacizumab helps delay disease progression, it may not necessarily extend overall survival.
Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study.Saltz, LB., Clarke, S., Díaz-Rubio, E., et al.[2023]

Citations

Advanced gastric cancer: an update and future directions. [2021]
A phase II study of capecitabine, oxaliplatin, and bevacizumab in the treatment of metastatic esophagogastric adenocarcinomas. [2022]
Cisplatin Plus Capecitabine After Adjuvant S-1 in Metastatic Gastric Cancer: A Phase II T-CORE1102 Trial. [2022]
[Neo-adjuvants, adjuvants and palliative therapy for gastric carcinoma]. [2008]
Emerging role of capecitabine in gastric cancer. [2022]
Managing patients treated with bevacizumab combination therapy. [2015]
Safety and Efficacy of Bevacizumab in Cancer Patients with Inflammatory Bowel Disease. [2022]
Bevacizumab in Combination With Oxaliplatin-Based Chemotherapy As First-Line Therapy in Metastatic Colorectal Cancer: A Randomized Phase III Study. [2023]
Incidence and management of ZIv-aflibercept related toxicities in colorectal cancer. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. [2023]
11.Korea (South)pubmed.ncbi.nlm.nih.gov
Chemotherapy for advanced gastric cancer: review and update of current practices. [2023]
[Patient with stomach cancer with metastases. What is the value of chemotherapy?]. [2013]
Chemotherapy of gastric cancer. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Pemetrexed in patients with gastrointestinal carcinoma. [2019]
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