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NCT06324357 · ClinicalTrials.gov registry record · Phase 1
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
A Phase 1 study of Colorectal Cancer and Metastatic Breast Cancer, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 768
- Enrollment target
- 20
- Study locations
NCT06324357: Recruiting Phase 1 study of Colorectal Cancer and Metastatic Breast Cancer, sponsored by Boehringer Ingelheim.
NCT06324357 is a Phase 1 study of Colorectal Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 768 participants, below the 1,543-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06324357, a Phase 1 study of Colorectal Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 768 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab and capecitabine, with zanidatamab, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. In this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.
Primary Outcome
The MTD evaluation period is defined as the first 21 days of the first treatment cycle for Cohorts A, B, C, G, K, and O. The MTD evaluation period is defined as the first 28 days after the first administration of any trial medication for Cohorts M and N.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Trastuzumab deruxtecan
- DRUG Trastuzumab emtansine
- DRUG Zongertinib
Study Locations (20)
California
- The Oncology Institute of Hope and Innovation - Cerritos
- Ellison Medical Institute - Los Angeles
- Valkyrie Clinical Trials - Los Angeles
- University of California Los Angeles - Los Angeles
- University of California Irvine - Orange
- Sharp Memorial Hospital - San Diego
Florida
- Mayo Clinic - Florida - Jacksonville
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Tennessee
- Baptist Cancer Center - Memphis - Memphis
- SCRI Oncology Partners - Nashville
Arizona
- Mayo Clinic-Arizona - Phoenix
Connecticut
- Yale University School of Medicine - New Haven
Indiana
- Community Health Network - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 768 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2029-01-08 |
| Phase | Phase 1 |
What NCT06324357 shows while recruiting
NCT06324357 is an interventional study that assigns participants to a tested intervention. The registered 768 participants enrollment target is mid-sized for trials with a published cap, below the 1,543-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (50% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT06324357 names 20 study sites across 12 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06324357 about?
NCT06324357 is a clinical study titled "Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread". This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suit...
What is the current status of trial NCT06324357?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 768 participants. The study started on 2024-06-03. Estimated completion is 2029-01-08.
What conditions does trial NCT06324357 study?
This clinical trial studies the following conditions: Colorectal Cancer, Metastatic Breast Cancer, Esophageal Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Metastatic Gastric Adenocarcinoma.
What interventions are being tested in trial NCT06324357?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Trastuzumab deruxtecan (DRUG), Trastuzumab emtansine (DRUG), Zongertinib (DRUG).
Who is sponsoring clinical trial NCT06324357?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06324357 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06324357's enrollment target sits among peer trials
768 60th of 381 higher than 321 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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