Home › Trials › NCT06695845

Evaluating zanidatamab for HER2-expressing tumors

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)

Phase 2 Interventional Jazz Pharmaceuticals · NCT06695845

This study is testing a new drug called zanidatamab to see if it can help people with certain types of cancer that have high levels of HER2 and who have already tried other treatments without success.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorJazz Pharmaceuticals Industry-sponsored
Drugs / interventionstrastuzumab, zanidatamab
Locations21 sites (Prescott, Arizona and 20 other locations)
Trial IDNCT06695845 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of zanidatamab in patients with solid tumors that express Human Epidermal Growth Factor Receptor 2 (HER2) at high levels (IHC 3+). Participants must have previously received treatment and have no available options that have shown benefit. The study focuses on various cancers, including breast, gastric, esophageal, gastroesophageal, and colorectal cancers. Patients will be monitored for measurable lesions to assess treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have progressed after at least one prior treatment and exhibit HER2 IHC 3+ overexpression.

Not a fit: Patients with biliary tract cancer or those who have not previously received systemic treatment for their advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-expressing tumors who have limited treatment alternatives.

How similar studies have performed: Other studies targeting HER2 have shown promising results, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Is at least 18 years of age inclusive at the time of signing the informed consent
2. 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.
3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
4. All participants must have adequate tumor sample for submission to allow central HER2 testing.
5. 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)
6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Has a life expectancy of at least 3 months, in the opinion of the investigator.
8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:

   1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
   2. 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.
   3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
9. Adequate organ functions.
10. Females of childbearing potential must have a negative pregnancy test result.
11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.

Exclusion Criteria:

1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
2. Has uncontrolled or significant cardiovascular disease
3. Has ongoing toxicity related to prior cancer therapy
4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
5. Has known Human Immunodeficiency Virus (HIV) infection.
6. Has active hepatitis B or C infection.
7. Has an active SARS-CoV-2 infection.
8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
9. 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.
10. 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.
11. Prior treatment with HER2-targeted therapy (Cohort 1 only).
12. Has a history of trauma or major surgery
13. 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.
14. Received zanidatamab at any time prior to the current study.
15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
18. 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.

Where this trial is running

Prescott, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerGastric CancerEsophageal CancerGastroesophageal CancerColorectal CancerEndometrial CancerNon-small Cell Lung CancerOvarian Cancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.