New drug duo aims to halt stomach cancer spread
NCT ID NCT06043427
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study tests whether adding a drug called zanidatamab to the usual chemotherapy can slow or stop the growth of advanced stomach, esophagus, or gastroesophageal junction cancer that is HER2-positive. About 168 adults who have already tried one standard treatment will be randomly assigned to receive either the usual drugs alone or with zanidatamab. The goal is to see if the new combination helps people live longer without their cancer getting worse.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 Criteria: * Participants must have histologically or pathologically confirmed gastroesophageal adenocarcinoma (stomach, gastroesophageal junction or esophagus) that is unresectable or metastatic and which must be HER2 positive as confirmed by central testing using FDA-approved HER2 assay. HER2 positive is defined as IHC 3+, or IHC 2+ and FISH positive. * Participants must have received and failed at least one prior trastuzumab-containing regimen in combination with platinum-based chemotherapy for treatment of locally advanced or metastatic disease. Failure is defined as demonstrated objective disease progression (radiologic) on the most recently administered HER2 targeting agent. * Participants must have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). * Participants must be considered a suitable candidate for, and able to receive chemotherapy for advanced disease with paclitaxel and ramucirumab. * Participants must consent to the provision of samples of blood, serum and plasma in order that the specific correlative marker assays may be conducted. * Participants must consent to provision of, and investigator(s) must confirm access to a representative formalin fixed paraffin embedded (FFPE) block of tumour tissue/ or a predetermined number of freshly cut slides of representative tumour tissue of adequate amount and quality in order that the central HER2 testing may be done * Participants must be ≥ 18 years of age. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must have a life expectancy of at least 12 weeks at the time of study entry * Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be done within 28 days prior to randomization * Participants must have adequate cardiac function by ECHO or MUGA defined as EF ≥ 50%. This is to be performed within 4 weeks (preferred) but no more than 8 weeks prior to randomization * Participants must have adequate normal organ and marrow function * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English or French * Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. * Participant must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment * Participants of childbearing potential must have agreed to use a highly effective contraceptive method for the entire period of study treatment and for at least 7 months after discontinuing study therapy. Exclusion Criteria: * Participants with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years. Patients with a history of other malignancies detected at an early stage and whom the investigator believes have been curatively treated and are at a low risk of recurrence MAY be eligible * Participants receiving therapy in a concurrent clinical study. Patients must agree not to participate in other clinical studies during their participation in this trial while on study treatment * Participants with active or uncontrolled intercurrent illness * Participants with human immunodeficiency virus infection (positive HIV 1/2 antibodies), active hepatitis B infection (positive HBV surface antigen (HBsAg)) or positive for hepatitis C (HCV) antibody may be considered for enrollment, if infection is adequately controlled in the opinion of the investigator. * Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy * Any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol * Any unresolved toxicity (CTCAE grade 2 or greater) from previous anti-cancer therapy which in the opinion of the investigator puts the participant at higher than expected risk during protocol treatment. However, participants with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational products in the Investigator's opinion may be included.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
18 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allan Blair Cancer Centre
RECRUITINGRegina, Saskatchewan, S4T 7T1, Canada
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Arthur J.E. Child Comprehensive Cancer Centre
RECRUITINGCalgary, Alberta, T2N 5G2, Canada
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BCCA - Vancouver
RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
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CHUM-Centre Hospitalier de l'Universite de Montreal
RECRUITINGMontreal, Quebec, H2X 3E4, Canada
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CancerCare Manitoba
RECRUITINGWinnipeg, Manitoba, R3E 0V9, Canada
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Centre Integre Universitaire De Sante Et De Services
RECRUITINGMontreal, Quebec, H4J 1C5, Canada
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Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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Kingston Health Sciences Centre
RECRUITINGKingston, Ontario, K7L 2V7, Canada
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Lakeridge Health Oshawa
RECRUITINGOshawa, Ontario, L1G 2B9, Canada
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London Health Sciences Centre Research Inc.
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Odette Cancer Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Ottawa Hospital Research Institute
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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QEII Health Sciences Centre
RECRUITINGHalifax, Nova Scotia, B3H 1V7, Canada
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Royal Victoria Regional Health Centre
RECRUITINGBarrie, Ontario, L4M 6M2, Canada
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Saskatoon Cancer Centre
RECRUITINGSaskatoon, Saskatchewan, S7N 4H4, Canada
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St. Michael's Hospital
RECRUITINGToronto, Ontario, M5B 1W8, Canada
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University Health Network
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Waterloo Regional Health Network (WRHN)
RECRUITINGKitchener, Ontario, N2G 1G3, Canada
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