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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 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 1,509-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 12 states.

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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.

Conditions Studied

Colorectal Cancer Metastatic Breast Cancer Esophageal Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Metastatic Gastric Adenocarcinoma

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

FieldValue
Enrollment Target 768 participants
Start Date 2024-06-03
Est. Completion 2029-01-08
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06324357

The ClinicalTrials.gov registry entry for NCT06324357 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 768 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,509-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (49% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.