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New drug combo shows promise for Hard-to-Treat GI cancers

NCT ID NCT03929666

Disease control Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new drug called zanidatamab (ZW25) combined with standard chemotherapy in 74 people with advanced HER2-positive cancers of the stomach, bile duct, or colon. The goal was to see if the combination is safe and shrinks tumors. Results will help decide if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zanidatamab (ZW25) plus standard chemotherapy drugs
What this could lead to
If successful, this could point toward a more effective first-line treatment option for people with HER2-positive gastrointestinal cancers.
What could go wrong
This is a small, early-phase trial (Phase 2) with no control group, so results may not confirm real benefit. Side effects from combining multiple drugs could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

74 people

The number who actually took part.

Started

Aug 2019

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 HER2-targeted agent * Prior systemic anti-cancer therapy (including investigational products) except prior adjuvant/neoadjuvant therapy, which must be completed at least 6 months prior to first study treatment dosing. For subjects with BTC and CRC the following additional exceptions apply: * BTC: patients may have started therapy for advanced disease but may not have received more than one cycle of any standard gemcitabine-based chemotherapy regimen. * CRC: patients may have started therapy for advanced disease but may not have received more than one cycle of 5-FU-based chemotherapy (\< 1 month of therapy). * Patients with certain contraindications to bevacizumab cannot be enrolled on the mFOLFOX6-2 with bevacizumab arm. * Palliative radiotherapy is allowed if completed at least 2 weeks prior to first study treatment dosing * Untreated known brain metastases (patients with treated brain metastases who are off steroids, off antiseizure medications, and stable for at least 1 month at the time of screening are eligible) * Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Patients with known myocardial infarction or unstable angina within 6 months prior to randomization are also excluded. * QTc Fridericia (QTcF) \> 470 ms. For patients with longer QTcF on initial electrocardiogram (ECG), follow-up ECG may be performed in triplicate to determine eligibility * Peripheral neuropathy \> Grade 1 per NCI-CTCAE v5.0 * Clinically significant interstitial lung disease * Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Active hepatitis B or hepatitis C infection or infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2 (Exception: patients with well controlled HIV \[e.g., CD4 \> 350/mm3 and undetectable viral load\] are eligible)

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms cholangiocarcinoma colorectal cancer colorectal neoplasm digestive system neoplasm Esophageal Neoplasms gastric neoplasm gastroesophageal adenocarcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-expressing gastrointestinal cancers, including gastroesophageal adenocarcinoma, biliary tract cancer, and colorectal cancer

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • CECIM Biocinetic

    Santiago, 8320000, Chile

  • Centro Internacional de Estudios Clínicos

    Santiago, 8420383, Chile

  • Centro de Investigacion Clinica SAGA

    Santiago, 7500653, Chile

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663, United States

  • Icegclinic Research & Care

    Santiago, 8241479, Chile

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2C1, Canada

  • Pusan National University

    Busan, 49241, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • The Cancer and Hematology Centers

    Grand Rapids, Michigan, 49503, United States

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6, Canada

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.