Neoplasms Clinical Trial
Official title:
Phase I, Non-randomized, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Weekly Repeated Intravenous Infusions in Patients With Advanced Solid Tumors.
This is a Phase I, multi-centre, non-randomized, uncontrolled, open-label, dose escalating
study of BI 836880 administered intravenously once a week. The eligible patient population
will be patients with advanced solid tumors.
The primary objective of this trial is to determine the maximum tolerated dose (MTD) and
recommended Phase II doses for BI 836880 in patients with solid tumors. Preliminary safety
data will be evaluated as secondary objectives.
Subsequently, pharmacokinetic profile, pharmacodynamic changes in circulating biomarkers and
Dynamic Contrast-Enhanced Magnetic Resonance Imaging ( DCE-MRI), anti-tumor activity and the
immunogenicity of BI 836880 will be explored up to a total of 40 patients with advanced solid
tumors.
Dose escalation will be guided by a Bayesian logistic regression model with over dose control
(EWOC) using at least 2 patients per dose cohorts.
Safety criteria will be followed, including adverse events according to Common Terminology
Criteria (CTCAE version 4.03), incidence of dose limiting toxicities, physical examination,
vital signs, safety laboratory parameters and Eastern Cooperative Oncology Group (ECOG).
n/a
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