Beamion™ BCGC‑1: Phase Ib/II zongertinib study in HER2‑positive mBC, metastatic GI cancers, or mCRC (NCT06324357)

Beamion™ BCGC-1: A Phase Ib dose escalation and Phase II dose optimization, randomized, open-label, multi-center trial of oral zongertinib alone or in combination with other agents for the treatment of patients with advanced HER2-positive metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (mGEAC), or metastatic colorectal cancer (mCRC) (NCT06324357)^1–3

*Two selected zongertinib doses per cohort.
DEC, Dose Escalation Committee; GI, gastrointestinal; HER2(+), human epidermal growth receptor 2 (positive); mBC, metastatic breast cancer; mCRC, metastatic colorectal cancer; mGEAC, metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma; OR, objective response; PFS, progression-free survival; PK, pharmacokinetics; PROs, patient-reported outcomes; T-DM1, trastuzumab emtansine; T-DXd, trastuzumab deruxtecan; treatment-emergent adverse event.