Trial Profile

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) in Combination With Intravenous Trastuzumab Deruxtecan (T-DXd) or in Combination With Intravenous Trastuzumab Emtansine (T-DM1) for Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC) and Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 22 Jun 2025

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At a glance

Drugs Trastuzumab emtansine (Primary) ; Trastuzumab-deruxtecan (Primary) ; Zongertinib (Primary)
Indications Adenocarcinoma; Gastric cancer; HER2 positive breast cancer; Oesophageal cancer
Focus Adverse reactions; Therapeutic Use
Acronyms Beamion BCGC-1
Sponsors Boehringer Ingelheim

11 Jun 2025 Planned End Date changed from 21 Aug 2028 to 28 Sep 2029.
11 Jun 2025 Planned primary completion date changed from 22 Feb 2027 to 28 Sep 2029.
07 Feb 2025 Planned number of patients changed from 240 to 582.

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