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Association details:
| Biomarker: | HER-2 amplification |
|---|---|
| Cancer: | Solid Tumor |
| Drug: | zongertinib (BI 1810631) (HER2 exon 20 mutation inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
Excerpt:
...- Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)...
Trial ID:
Source:
Title:
Beamion Lung 1, a Phase Ia/Ib Trial of the HER2 TKI, BI 1810631 in Patients with Advanced Solid Tumors with HER2 Aberrations
Published date:
08/08/2023
Excerpt:
Patients with HER2 aberration-positive (overexpression, gene amplification/rearrangements, or somatic mutation) advanced/unresectable/metastatic solid tumors refractory/unsuitable for standard therapy were enrolled. Patients received escalating doses of BI 1810631 BID...These preliminary data indicate that BI 1810631 is well tolerated and shows strong efficacy signals across all dose levels in patients with pre-treated HER2 aberration-positive solid tumors.
Source:
Title:
40P - Updated data from the Phase I Beamion Lung 1 trial of BI 1810631, a HER2 TKI, in patients (pts) with advanced solid tumours with HER2 aberrations
Published date:
03/23/2023
Excerpt:
Pts with HER2 aberration-positive (overexpression, gene amplification/rearrangements or somatic mutation) advanced/unresectable/metastatic solid tumours refractory/unsuitable for standard therapy were enrolled….Preliminary data indicate that BI 1810631 is well tolerated and shows encouraging anti-tumour activity in pts with HER2 aberration-positive solid tumours. Phase Ia recruitment is ongoing.
Trial ID:
