Testing Zongertinib for Advanced Cancers with HER2 Alterations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of zongertinib in treating adults with advanced cancers that have HER2 alterations, particularly after previous treatments have failed. Participants, aged 18 and older, will be grouped based on their specific type of advanced cancer and HER2 alteration. Each participant will take a daily dose of zongertinib and will be monitored regularly for tumor size and health status. The goal is to determine if zongertinib can provide therapeutic benefits for these patients.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Patients aged ≥18 years
* Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
* Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours
* Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options
* Availability of archival tumour tissue sample to confirm HER2 status
* Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply.

Exclusion criteria:

* Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer
* Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)
* Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)
* Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment
* Uncontrolled or symptomatic brain or subdural metastases during screening
* Known diagnosis of leptomeningeal disease
* Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.

Where it's running

• Alaska Oncology and Hematology, LLC
  Anchorage, Alaska, United States Recruiting
• Precision NextGen Oncology
  Beverly Hills, California, United States Recruiting
• Scripps Cancer Center Torrey Pines
  La Jolla, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting
• BRCR Global - Tamarac
  Tamarac, Florida, United States Recruiting

+43 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.