Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer
Status:
Completed
Trial end date:
2017-08-02
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum
Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination
with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)
overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of
a dose escalation part and a dose expansion part. LJM716 will be administered intravenously
once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks
is introduced. Patients will continue on their trastuzumab dosing, administered intravenously
once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be
treated in successive cohorts. The dose escalation will continue until the MTD/RDE is
declared. The RDE dose selected will either be the MTD or a dose below the MTD based on
safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE
declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in
the dose expansion part and treated at the MTD/RDE to further assess the safety,
tolerability, and anti-tumor activity of the combination.