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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
CRC: Same as Part 1
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My condition meets the criteria outlined in Part 1.
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My bile duct cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.
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My heart's left ventricle is functioning well.
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My stomach cancer is advanced or has spread and tests show it is HER2 positive.
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My colorectal cancer is advanced, cannot be surgically removed, and tests positive for HER2 without certain gene mutations.
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My stomach cancer is advanced and cannot be removed by surgery, and it tests positive for HER2.
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My organs are working well.
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I have been diagnosed with a specific disease.
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This information is part of a larger set of criteria.
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This information is part of a multi-step process.
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My cancer can be measured or observed.
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I am fully active or can carry out light work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (Part 1)
Incidence of dose-limiting toxicities (DLTs) (Part 1)
Incidence of lab abnormalities (Part 1)
+1 more
Secondary outcome measures
Clinical benefit rate (Parts 1 and 2)
Disease control rate (Parts 1 and 2)
Duration of response (Parts 1 and 2)
+9 more

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
Leucovorin
2005
Completed Phase 4
~5730
Gemcitabine
2017
Completed Phase 3
~2070
Fluorouracil
2014
Completed Phase 3
~11540
Bevacizumab
2013
Completed Phase 4
~5280
Cisplatin
2013
Completed Phase 3
~1940
Oxaliplatin
2011
Completed Phase 4
~2560
Capecitabine
2013
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Zymeworks Inc.Lead Sponsor
10 Previous Clinical Trials
2,235 Total Patients Enrolled
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,285 Total Patients Enrolled
Phillip Garfin, MD, PhDStudy DirectorJazz Pharmaceuticals
3 Previous Clinical Trials
189 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03929666 — Phase 2
Gastrointestinal Cancers Research Study Groups: ZW25 + mFOLFOX6 with bevacizumab, ZW25 + FP, ZW25 + CisGem, ZW25 + mFOLFOX6, ZW25 + XELOX
Gastrointestinal Cancers 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been associated with the use of Zanidatamab (ZW25)?

"There is some evidence suggesting ZW25 (Zanidatamab) may be safe, so it was allocated a rating of 2. However, since this Phase 2 trial there are no available data that point to the drug's efficacy."

Answered by AI

Is there precedent for medical research involving Zanidatamab (ZW25)?

"Currently, 1771 clinical trials are evaluating the efficacy of ZW25 (Zanidatamab). Of those studies, 563 have reached Phase 3. In all 81965 medical centres across Guangzhou, Guangdong are running these tests."

Answered by AI

Is enrollment open to participants for this research?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical trial, which began recruiting on August 29th 2019, is still searching for participants to enroll in the study. 362 individuals need to be enrolled across 8 centres nationwide."

Answered by AI

What is the cap for enlistment in this medical experiment?

"This clinical study requires 362 suitable patients to be enrolled. Zymeworks Inc., is managing the protocol from Omaha's Nebraska Methodist Hospital and USC/Norris Comprehensive Cancer Center in LA, California."

Answered by AI

How many facilities are involved in conducting this research experiment?

"This study is conducted in 11 sites, including Nebraska Methodist Hospital (Omaha), USC/Norris Comprehensive Cancer Center (Los Angeles), and Cancer and Hematology Centers of Western Michigan (Kalamazoo) as well as 8 additional locations."

Answered by AI

What medical indications is Zanidatamab (ZW25) commonly employed to treat?

"Zanidatamab (ZW25) is the drug of choice for treating urinary bladder cancer, as well as advanced testicular carcinoma, refractory fallopian tube malignancy and small cell lung neoplasia."

Answered by AI
~19 spots leftby Nov 2025