Recruiting
Phase 2

Zongertinib

Sponsor:

Boehringer Ingelheim

Code:

NCT06581432

Conditions

Solid Tumours

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zongertinib

Study Details

Brief summary:

This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study. The purpose of this study is to find out whether a medicine called zongertinib helps people with advanced cancers with HER2 alterations. HER2 alterations can cause cancer. Zongertinib inhibits HER2.

Participants are put into groups based on the type of advanced cancer they have, the type of HER2 alterations they have, and the dose of zongertinib they receive. Depending on the group they are in, participants take 1 of 2 different doses of zongertinib each day. Participants can continue the treatment as long as they benefit from it and can tolerate it.

Participants visit the study site regularly. During many of the visits, the doctors check the size of the tumour and whether it has spread to other parts of the body. During all the visits, the doctors check participants' health and take note of any unwanted effects.

Conditions

Solid Tumours

Study ID

NCT06581432

Start date

Oct 11, 2024

Status verified date

Oct, 2026

Completion date

Dec 29, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

588 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Zongertinib treatment

Interventions

Zongertinib

Zongertinib

Primary outcome measure

  • Proportion of patients with objective response (OR) [ Time Frame: Up to 51 months ]

Central Contacts and Locations

Central contacts

Boehringer Ingelheim

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Locations

Alaska Oncology and Hematology, LLC

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Precision NextGen Oncology

Recruiting

Beverly Hills, California, United States, 90212

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Scripps Cancer Center Torrey Pines

Recruiting

La Jolla, California, United States, 92037

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

BRCR Global - Tamarac

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Community MD Anderson Cancer Center - East Medical Oncology

Recruiting

Indianapolis, Indiana, United States, 46219

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Maryland Oncology Hematology, Columbia

Recruiting

Columbia, Maryland, United States, 21044

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Presbyterian Healthcare Services

Recruiting

Albuquerque, New Mexico, United States, 87110

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Memorial Sloan-Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Alliance Cancer Specialists, PC, Wynnewood

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Sarah Cannon Research Institute at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Texas Oncology - Plano West

Recruiting

Plano, Texas, United States, 75093

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Virginia Cancer Specialists, PC

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Cross Cancer Institute (University of Alberta)

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

BC Cancer Agency - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Boehringer Ingelheim

18336022346canada@bitrialsupport.com

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.