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

Human epidermal growth factor receptor 2 (HER2, encoded by <i>ERBB2</i>) alterations are known oncogenic drivers in many solid tumors. Zongertinib is a novel, oral, irreversible, HER2-selective tyrosine kinase inhibitor that spares wild-type epidermal growth factor receptor, thereby limiting associated toxicities. In a Phase Ia/Ib trial (NCT04886804), zongertinib demonstrated encouraging activity with a manageable safety profile in HER2-altered tumors (HER2 overexpression, amplification, or mutations).The Phase II, open-label, Beamion PANTUMOR-1 basket trial (NCT06581432) is evaluating the efficacy and safety of zongertinib monotherapy in previously treated patients with HER2-positive (HER2-overexpressed/amplified) or <i>HER2</i>-mutant solid tumors. Patients with HER2-positive tumors will be enrolled to one of eight cohorts: urothelial, biliary tract, uterine, cervical, non-squamous lung, salivary gland, colorectal or tumor agnostic. Patients with <i>HER2</i>-mutant tumors will be enrolled to one of five cohorts: urothelial, breast, gastroesophageal, biliary tract or tumor agnostic. Patients will receive zongertinib 120 mg orally once daily until disease progression (RECIST v1.1), unacceptable toxicity, death, or withdrawal of patient consent, whichever occurs first. The primary endpoint is objective response (central independent review, RECIST v1.1). Secondary endpoints include duration of response, progression-free survival, disease control, occurrence of treatment-emergent adverse events, and health-related quality of life. Recruitment is ongoing in 13 countries globally.Clinical trial registration http://www.clinicaltrials.gov identifier is NCT06581432.

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Publication Details

Journal
Future Oncology
Published
2026-03-04
DOI
https://doi.org/10.1080/14796694.2026.2637740
Primary Topic
HER2/EGFR in Cancer Research
Type
article
Field-Weighted Citation Impact
0.00

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article

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

Daniel Martin Klotz, Alberto Hernando‐Calvo, Shigehisa Kitano, Lukas Lunger et al.
Future Oncology
HER2/EGFR in Cancer Research
article

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

Daniel Martin Klotz, Alberto Hernando‐Calvo, Shigehisa Kitano, Lukas Lunger, Philippe Lucien Bedard, Yuta Maruki, Daniela Maier, J. Park, Alison M. Schram, Li Jin, Timothy Clay, Y. P. Guo, R. Ko, Mariano Ponz-Sarvise, Cédric Van Marcke, Damijan Eržen, Antoine Italiano, Jo Hussain, Hyung-Don Kim, John J Park, David Planchard, Ecaterina Dumbrava, Hans Prenen
article en

Abstract

Human epidermal growth factor receptor 2 (HER2, encoded by <i>ERBB2</i>) alterations are known oncogenic drivers in many solid tumors. Zongertinib is a novel, oral, irreversible, HER2-selective tyrosine kinase inhibitor that spares wild-type epidermal growth factor receptor, thereby limiting associated toxicities. In a Phase Ia/Ib trial (NCT04886804), zongertinib demonstrated encouraging activity with a manageable safety profile in HER2-altered tumors (HER2 overexpression, amplification, or mutations).The Phase II, open-label, Beamion PANTUMOR-1 basket trial (NCT06581432) is evaluating the efficacy and safety of zongertinib monotherapy in previously treated patients with HER2-positive (HER2-overexpressed/amplified) or <i>HER2</i>-mutant solid tumors. Patients with HER2-positive tumors will be enrolled to one of eight cohorts: urothelial, biliary tract, uterine, cervical, non-squamous lung, salivary gland, colorectal or tumor agnostic. Patients with <i>HER2</i>-mutant tumors will be enrolled to one of five cohorts: urothelial, breast, gastroesophageal, biliary tract or tumor agnostic. Patients will receive zongertinib 120 mg orally once daily until disease progression (RECIST v1.1), unacceptable toxicity, death, or withdrawal of patient consent, whichever occurs first. The primary endpoint is objective response (central independent review, RECIST v1.1). Secondary endpoints include duration of response, progression-free survival, disease control, occurrence of treatment-emergent adverse events, and health-related quality of life. Recruitment is ongoing in 13 countries globally.Clinical trial registration http://www.clinicaltrials.gov identifier is NCT06581432.

Future OncologyVol. 22(7)
Ulsan College (KR), Tongji University (CN), Hebron University (PS), St John of God Subiaco Hospital (AU), Cliniques Universitaires Saint-Luc (BE), University Health Network (CA), Memorial Sloan Kettering Cancer Center (US), The University of Texas MD Anderson Cancer Center (US), Université de Bordeaux (FR), Université Paris-Saclay (FR), Institut Gustave Roussy (FR), Samsung Medical Center (KR), Health Net (US), University of Ulsan (KR), Shizuoka Cancer Center (JP), National Cancer Center (US), Antwerp University Hospital (BE), Vall d'Hebron Institut de Recerca (ES), Boehringer Ingelheim (Egypt) (EG), Institut Bergonié (FR), Clinica Universidad de Navarra (ES), The Cancer Institute Hospital (JP), Boehringer Ingelheim (China) (CN), Boehringer Ingelheim (Australia) (AU), Japanese Foundation For Cancer Research (JP), Sungkyunkwan University (KR), Macquarie University (AU)
Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Gilead Sciences, American Society of Clinical Oncology, Celgene, Merck KGaA, Taiho Pharmaceutical, Novocure, Mersana Therapeutics, BeiGene, Incyte, Revolution Medicines, Relay Therapeutics, Moderna, Seagen, Rakuten Medical, Eisai, Astellas Pharma, Servier, Ono Pharmaceutical, Ipsen, Genentech, Chugai Pharmaceutical, Eli Lilly Japan, Daiichi Sankyo Europe
Partnerships for the goals
Openalex Percentile: Top 33%
HER2/EGFR in Cancer Research
DOIOpen Access PDFOpenAlex
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