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Monoclonal Antibodies

Zanidatamab + Chemotherapy for Gastrointestinal Cancers

Phase 2
Waitlist Available
Research Sponsored by Zymeworks Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BTC: Unresectable, locally advanced, recurrent or metastatic HER2-expressing BTC (including intrahepatic cholangiocarcinoma [ICC], extrahepatic cholangiocarcinoma [ECC], or gallbladder cancer [GBC]) (IHC 3+ with or without gene amplification; or IHC 0, 1+ or 2+ with gene amplification, based upon central assessment)
Adequate cardiac left ventricular function, as defined by a LVEF >/= institutional standard of normal
Must not have
Prior treatment with a HER2-targeted agent
Peripheral neuropathy > Grade 1 per NCI-CTCAE v5.0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug, zanidatamab, to see if it is safe and effective for treating certain types of gastrointestinal cancers. Eligible patients have cancer that has spread and cannot be removed by surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include reactions related to infusion of the drugs, nausea, vomiting from chemotherapy; increased risk of bleeding or blood clots due to Bevacizumab; nerve damage symptoms like tingling or numbness from Oxaliplatin; and general fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bile duct cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.
Select...
My heart's left ventricle is functioning well.
Select...
My stomach cancer is advanced or has spread and tests show it is HER2 positive.
Select...
My colorectal cancer is advanced, cannot be surgically removed, and tests positive for HER2 without certain gene mutations.
Select...
My stomach cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.
Select...
My cancer can be measured or observed.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with a HER2-targeted therapy before.
Select...
My nerve damage does not severely affect my daily activities.
Select...
I do not have serious heart conditions or recent heart attacks.
Select...
I do not have any health conditions that prevent me from taking bevacizumab.
Select...
I don't have another cancer that could affect this treatment's safety or results.
Select...
I have a serious lung condition affecting the tissue and space around the air sacs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (Part 1)
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Incidence of lab abnormalities (Part 1)
+1 more
Secondary study objectives
Clinical benefit rate (Parts 1 and 2)
Disease control rate (Parts 1 and 2)
Duration of response (Parts 1 and 2)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
2013
Completed Phase 3
~3960
Cisplatin
2013
Completed Phase 3
~3120
Oxaliplatin
2011
Completed Phase 4
~2890
Bevacizumab
2013
Completed Phase 4
~5540
ZW25 (Zanidatamab)
2020
Completed Phase 2
~90
Fluorouracil
2014
Completed Phase 3
~11700
Leucovorin
2005
Completed Phase 4
~6010
Gemcitabine
2017
Completed Phase 3
~1920

Find a Location

Who is running the clinical trial?

Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,397 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,767 Total Patients Enrolled
Jonathan Grim, MD, PhDStudy DirectorZymeworks Inc.
1 Previous Clinical Trials
918 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03929666 — Phase 2
Cancer Research Study Groups: ZW25 + mFOLFOX6 with bevacizumab, ZW25 + FP, ZW25 + mFOLFOX6, ZW25 + XELOX, ZW25 + CisGem
Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03929666 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03929666 — Phase 2
~8 spots leftby Jul 2025
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