Zanidatamab + Chemotherapy for Gastrointestinal Cancers

Recruiting at25 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Zymeworks Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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).

Research Team

Phillip Garfin, MD, PhD

Principal Investigator

Jazz Pharmaceuticals

Eligibility Criteria

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.

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.

Treatment Details

Interventions

• Bevacizumab (Monoclonal Antibodies)
• Capecitabine (Anti-metabolites)
• Cisplatin (Alkylating agents)
• Fluorouracil (Anti-metabolites)
• Gemcitabine (Anti-tumor antibiotic)
• Leucovorin (Other)
• Oxaliplatin (Alkylating agents)
• ZW25 (Zanidatamab) (Monoclonal Antibodies)

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.

Participant Groups

Group I: ZW25 + mFOLFOX6 with bevacizumab Experimental Treatment 5 Interventions

ZW25 plus 5-FU, leucovorin, oxaliplatin, and bevacizumab

Group II: ZW25 + mFOLFOX6 Experimental Treatment 4 Interventions

ZW25 plus 5-FU, leucovorin, and oxaliplatin

Group III: ZW25 + XELOX Experimental Treatment 3 Interventions

ZW25 plus capecitabine and oxaliplatin

Group IV: ZW25 + FP Experimental Treatment 3 Interventions

ZW25 plus fluorouracil (5-FU) and cisplatin

Group V: ZW25 + CisGem Experimental Treatment 2 Interventions

ZW25 plus cisplatin and gemcitabine

Bevacizumab is already approved in Japan, Canada for the following indications:

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

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

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