An Open Label, Phase I Dose Escalation Trial, With Dose Confirmation and Expansion, of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations
NCT #
NCT04886804
Condition(s)
Lung Cancer (NSCLC), Solid Tumor
Molecular Target(s)
HER2
Drug Classification(s)
Targeted Therapy
Agents(s)
BI 1810631
Phase(s)
I
Mechanism of Action
BI 1810631 is an EGFR wild type sparing, selective HER2 inhibitor with potent inhibitory activity on all oncogenic HER2 mutations including the HER2 YVMA insertion allele.
Purpose
- How much of the study drug can be given with an acceptable level of side effects
- About the safety, effectiveness, and tolerability (side effects) of the study drug
- How much of the study drug is absorbed into the blood and how fast it is removed
- How proteins that indicate the status of your disease are affected with the use of the study drug
- If research tests can be used in the future to predict who will benefit from BI 1810631
- If the study drug prevents or delays tumor growth
- Whether giving the study drug 1 or 2 times per day is more effective and which dose and regimen have fewer side effects in people with solid tumor type cancer
Location
MCD
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