Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors - PubMed

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Zongertinib is a novel, oral, irreversible, HER2-selective tyrosine kinase inhibitor.
Phase II Beamion PANTUMOR-1 trial evaluates zongertinib in HER2-positive or HER2-mutant solid tumors.
Patients are enrolled into specific cohorts based on tumor type and HER2 status.
Primary endpoint is objective response rate assessed by central independent review.
Secondary endpoints include duration of response, progression-free survival, and safety.
Zongertinib showed promising activity in HER2-altered tumors in earlier Phase Ia/Ib trials.
Common side effects in previous studies were diarrhea and rash, both manageable.
Recruitment is ongoing in 13 countries globally.

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