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 suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken alone or together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab with or without capecitabine, with zanidatamab with or without docetaxel,

Trial Details

NCT ID
NCT06324357
Phase
PHASE1 / PHASE2
Sponsor
Boehringer Ingelheim
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • Zongertinib
  • Trastuzumab deruxtecan
  • Trastuzumab emtansine
  • Trastuzumab
  • Capecitabine
  • mFOLFOX6
Locations (sample)
  • Cerritos, California, United States|33.85835,-118.06479
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

  • Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informe…
  • Cohorts A to K and Cohort O and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast c…
  • Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplif…
  • For (Phase II): Patient must provide tumor tissue

For full eligibility, visit ClinicalTrials.gov.

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