CompletedPhase 2

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

United States, Canada, Chile74 participantsStarted 2019-08-29

Plain-language summary

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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion: * Disease diagnosis: * Part 1: * GEA: Unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA (IHC 3+ or 2+ with or without gene amplification based upon local assessment or central assessment) * 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) * CRC: Unresectable, locally advanced, recurrent or metastatic HER2-expressing CRC (IHC 3+ with or without gene amplification; or IHC 0, 1+ or 2+ with gene amplification, based upon central assessment). Patients will be required to be extended RAS (KRAS and NRAS) and BRAF wild-type based upon central assessment. * Part 2: * GEA: Unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA (IHC 3+, or IHC 2+ and FISH+ by central assessment) * BTC: Same as Part 1 * CRC: Same as Part 1 * Tumor measurements as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: * Part 1: Measurable or non-measurable disease * Part 2: Measurable disease * An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Adequate organ function * Adequate cardiac left ventricular function, as defined by a LVEF \>/= institutional standard of normal Exclusion: * Prior treatment with a H…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this Phase 2 trial of zanidatamab combined with chemotherapy for HER2-expressing cancers like mine has already completed, has the results data been published, and what did it show about response rates and safety in patients with my specific cancer type?
2The trial measured something called 'objective response rate' as a key outcome — based on the results, how does zanidatamab's response rate compare to what I might expect from standard HER2-targeted treatments already approved for my cancer?
3The study specifically tracked dose-limiting toxicities and adverse events — given that this was a Phase 2 trial, does my doctor feel there's enough safety data now to understand the real risks of combining zanidatamab with chemotherapy for someone in my situation?
4Since this trial covered three different cancer types — gastroesophageal adenocarcinoma, biliary tract cancer, and colorectal cancer — is the data relevant to my specific diagnosis, and were results different across those cancer types?
5Based on what this completed trial found, are there now follow-up trials, expanded access programs, or approved treatment options involving zanidatamab that might be worth exploring for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of dose-limiting toxicities (DLTs) (Part 1)

Timeframe: Up to 6 weeks

Incidence of adverse events (Part 1)

Timeframe: Up to 11 months

Incidence of lab abnormalities (Part 1)

Timeframe: Up to 11 months

Objective response rate (ORR) (Part 2)

Timeframe: Up to 10 months

Trial details

NCT IDNCT03929666

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer trials