Beamion™ PANTUMOR‑1: Phase II study of zongertinib in HER2‑altered solid tumors (NCT06581432)

Beamion™ PANTUMOR-1: A Phase II, multi-center, multi-cohort, open-label trial to evaluate the efficacy and safety of oral zongertinib for the treatment of selected HER2-mutated or HER2-overexpressed/amplified solid tumors (NCT06581432)^1,2

*In previous versions of the protocol, patients with HER2 overexpression ± mutations were also eligible; ^†Biliary tract cancer (includes cholangiocarcinoma, gallbladder cancer, and ampullary cancer); ^‡After implementation of CTP version 4.0, patients will be enrolled in Cohorts 14 to 21 (240 mg QD dose). Once these cohorts are full, HER2-amplified patients may be enrolled in Cohorts 2, 4, 5, 6, 11, and 12 at the discretion of the sponsor as long as slots remain available; ^​§Interim analysis after 10 patients pending.
BTC, biliary tract cancer; CTP, clinical trial protocol; DOR duration of objective response; GE, gastro-esophageal; HER2, human epidermal growth factor 2; NSCLC, non-small cell lung cancer; OS, overall survival; PFS progression-free survival; QD, once daily; QOL, quality of life; sq, squamous; TEAE, treatment emergent adverse events.