Tests zanidatamab in adults with HER2-expressing solid tumors that were previously treated
Tests zanidatamab in adults whose tumors overexpress HER2 and were treated before.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
Key facts
- Where
- Barcelona, Las Palmas, Madrid, Málaga, Pamplona, and Valencia, SpainSee the 8 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors with high HER2 levels (IHC 3+), whose cancer got worse after earlier treatment. They would receive zanidatamab.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced, unresectable or metastatic solid tumors (biliary tract cancer is not included) that got worse after at least 1 earlier systemic treatment, with no treatment of confirmed benefit left. At least 1 measurable lesion is needed.
- Earlier treatment
- At least 1 earlier systemic treatment is needed. Cohort 1 cannot have had HER2-targeted therapy. Breast cancer (Cohort 2) and GEA (Cohort 3) need earlier trastuzumab deruxtecan (T-DXd). No earlier zanidatamab.
- Biomarker or test result
- HER2 overexpression (IHC 3+), confirmed by the sponsor's central laboratory on a tumor sample.
Main reasons for not taking part
- Leptomeningeal disease or untreated brain metastases
- Known HIV infection
- Active hepatitis B or C infection
- Pregnant or breastfeeding, or planning a pregnancy
- Uncontrolled or significant heart disease
Read by machine on 12 November 2026.
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- Hospital Universitario Vall d'HebronBarcelona, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- Hospital Universitario Insular Gran CanariasLas Palmas, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- Hospital Regional Universitario de Malaga - Hospital GeneralMálaga, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- Complejo Hospitalario de NavarraPamplona, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
- INCLIVA-Hospital Clínico Universitario de ValenciaValencia, SpainContact: Clinical Trial Disclosure & TransparencyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jazz Pharmaceuticals
- Trial code
- NCT06695845EU 2024-516551-41-00
- Record updated
- 4 November 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.Read full original descriptionShow less
A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.
Inclusion: Is at least 18 years of age inclusive at the time of signing the informed consent; Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required; HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory; All participants must have adequate tumor sample for submission to allow central HER2 testing; Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Has a life expectancy of at least 3 months, in the opinion of the investigator; Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:; Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS; Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to < Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment > 7 days prior to Cycle 1 Day 1; Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention; Adequate organ functions; Females of childbearing potential must have a negative pregnancy test result; Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion: Prior treatment with HER2-targeted therapy (Cohort 1 only); Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1; Received zanidatamab at any time prior to the current study; Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen; Has known or suspected leptomeningeal disease and/or untreated brain metastasis; Has uncontrolled or significant cardiovascular disease; Has ongoing toxicity related to prior cancer therapy; Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals; Has known Human Immunodeficiency Virus (HIV) infection; Has active hepatitis B or C infection; Has an active SARS-CoV-2 infection; Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab; Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site; Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study; Has a history of trauma or major surgery; Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations; Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion; Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.