Brief Summary

The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.

The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.

The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.

In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.

The participants are in the study for as long as they benefit from and can tolerate treatment.

Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.

Conditions

• Neoplasm Metastasis
• Non-Small Cell Lung Cancer

Intervention / Treatment

• Drug: zongertinib

Primary Outcome Measures

• Phase Ia: Maximum Tolerated Dose (MTD) (At the end of Cycle 1 (each cycle is 21 days).)
  Maximum tolerated dose is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period in any studied regimen.
• Phase Ia: Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period (At the end of Cycle 1 (each cycle is 21 days).)
• Phase Ib - Cohorts 1, 2, 3 (enrolled from CTP v8.0), and 5: Objective response (OR) as assessed by central independent review (From the start of the trial treatment until end of month 12, up to 12 months.)
  OR is defined as best overall response of complete response (CR) or partial response (PR), where best overall response is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, from the first treatment administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anticancer therapy, loss to follow-up or withdrawal of consent.
• Phase Ib - Cohorts 3 (patients prior to CTP v8.0), 6, 7, 8, and 9: Objective response according to RECIST 1.1 by investigator assessment (From the start of the trial treatment until end of month 12, up to 12 months.)
  Clincal Trial Protocol version 8.0 = CTP v8.0
• Phase Ib: Cohort 4: Objective response according to Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) by central independent review (From the start of the trial treatment until end of month 12, up to 12 months.)

Countries

Australia, Austria, Belgium, China, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, South Korea, Spain, Sweden, United Kingdom, United States

Locations and Investigators

• University of Alabama at Birmingham, Birmingham, United States (Recruiting)
  • Boehringer Ingelheim
• Precision NextGen Oncology, Beverly Hills, United States (Completed)
• City of Hope-Duarte-56419, Duarte, United States (Recruiting)
  • Boehringer Ingelheim
• City of Hope - Seacliff, Huntington Beach, United States (Completed)
• City of Hope-Irvine-69674, Irvine, United States (Completed)
• Valkyrie Clinical Trials, Los Angeles, United States (Recruiting)
  • Boehringer Ingelheim
• University of California Irvine, Orange, United States (Recruiting)
  • Boehringer Ingelheim
• University of California Davis, Sacramento, United States (Recruiting)
  • Boehringer Ingelheim
• Georgetown University, Washington D.C., United States (Recruiting)
  • Boehringer Ingelheim
• Holy Cross Hospital-Fort Lauderdale-57892, Fort Lauderdale, United States (Recruiting)
  • Boehringer Ingelheim
• Winship Cancer Institute, Atlanta, United States (Recruiting)
  • Boehringer Ingelheim
• Hawaii Cancer Care - Honolulu, Honolulu, United States (Recruiting)
  • Boehringer Ingelheim
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, United States (Recruiting)
  • Boehringer Ingelheim
• Duke University Medical Center, Durham, United States (Recruiting)
  • Boehringer Ingelheim
• Cleveland Clinic, Cleveland, United States (Recruiting)
  • Boehringer Ingelheim
• Sarah Cannon Research Institute-Nashville-48456, Nashville, United States (Recruiting)
  • Boehringer Ingelheim
• Mary Crowley Cancer Research Center, Dallas, United States (Recruiting)
  • Boehringer Ingelheim
• The University of Texas MD Anderson Cancer Center, Houston, United States (Recruiting)
  • Boehringer Ingelheim
• Virginia Cancer Specialists, PC, Fairfax, United States (Recruiting)
  • Boehringer Ingelheim
• Fred Hutchinson Cancer Research Center, Seattle, United States (Recruiting)
  • Boehringer Ingelheim
• Macquarie University, Macquarie Park, Australia (Completed)
• Ordensklinikum Linz GmbH, Linz, Austria (Completed)
• Brussels - HOSP Jules Bordet, Anderlecht/Brussels-Capital, Belgium (Active not recruiting)
• Beijing Cancer Hospital, Beijing, China (Completed)
• Jilin Province Cancer Hospital, Changchun, China (Completed)
• The First Hospital of Jilin University, Changchun, China (Active not recruiting)
• Fujian Cancer Hospital, Fuzhou, China (Active not recruiting)
• Guangdong Provincial People's Hospital, Guangzhou, China (Active not recruiting)
• The First Affiliated Hospital, Zhejiang University, Hangzhou, China (Active not recruiting)
• Zhejiang Cancer Hospital, Hangzhou, China (Active not recruiting)
• Harbin Medical University Cancer Hospital, Harbin, China (Active not recruiting)
• The Affiliated Cancer Hospital, Guangxi Medical University, Nanning, China (Completed)
• Shanghai Chest Hospital, Shanghai, China (Completed)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China (Active not recruiting)
• Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T, Wuhan, China (Active not recruiting)
• First Affiliated Hospital of Xiamen University, Xiamen, China (Completed)
• Henan Cancer Hospital, Zhengzhou, China (Active not recruiting)
• The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China (Active not recruiting)
• Hopital Louis Pradel, Bron, France (Active not recruiting)
• CTR Leon Berard, Lyon, France (Active not recruiting)
• HOP Timone, Marseille, France (Active not recruiting)
• INS Curie, Paris, France (Active not recruiting)
• HOP Pontchaillou, Rennes, France (Active not recruiting)
• Institut Gustave Roussy, Villejuif, France (Active not recruiting)
• Universitätsklinikum Augsburg, Augsburg, Germany (Completed)
• Universitätsklinikum Köln (AöR), Cologne, Germany (Recruiting)
  • Boehringer Ingelheim
• Technische Universität Dresden, Dresden, Germany (Recruiting)
  • Boehringer Ingelheim
• Justus-Liebig Universität Gießen, Giessen, Germany (Recruiting)
  • Boehringer Ingelheim
• Pius-Hospital, Oldenburg, Oldenburg, Germany (Recruiting)
  • Boehringer Ingelheim
• Prince of Wales Hospital-Hong Kong-20715, Hong Kong, Hong Kong (Active not recruiting)

And 35 other sites.