Solid Tumors Clinical Trial
Official title:
NGR013: Phase I and Pharmacodynamic Study of NGR-hTNF Administered at High Doses in Patients With Advanced or Metastatic Solid Tumour
The main objective of the trial is to document the safety and antivascular effect of
escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by
advanced or metastatic solid tumors not amenable of standard therapies.
Safety will be established by clinical and laboratory assessment according to NCI-CTCAE
criteria (version 4.02).
Pre-clinical studies provide the support that NGR-TNF is endowed with a higher therapeutic
index in animal models and studies of the mechanism of action showed that NGR-TNF can induce
tumour necrosis when used at relatively high doses.
Recently, a phase I dose-escalation study of NGR-hTNF has explored the dose range between 0.2
and 60 µg/m2, showing DLT at 60 mcg/m2 experienced as transient acute infusion reaction few
minutes after the first administration start. Considering the relationship with the infusion
of these events, a further dose escalation will be explored in the present phase I study by
using both a longer infusion time (i.e., 120 minutes instead of 60 minutes) and a mild
premedication.
The first cohort (n=4) of patients will be treated with NGR-hTNF administered at 60 mcg/m2 IV
every three weeks, that is a dose level 33% higher than MTD and recommended dose selected in
the previous phase I trial (i.e., 45 mcg/m2). If ≤1 of 4 patients experience DLT during the
first cycle, following cohorts will be treated with escalating doses (from 80 to 325 mcg/m2)
of NGR-hTNF IV every three weeks.
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