The purpose of this study is to determine the recommended dose (RD) for further phase II studies, of the Galectin-1 inhibitor OTX008 given subcutaneously in patients with advanced solid tumors
Overexpression of galectin-1 protein is well documented in different types of cancers, with associated bad prognostic and enhanced metastases spreading. In-vitro/in-vivo preclinical studies showed that OTX008 inhibits galectin-1 expression. In different cancer models in animals, OTX008 reduced tumor growing and metastases spreading and it was observed a blood vessels architecture normalization. Thus, OTX008 appears to be an innovating approach to treat cancers and this clinical phase I study aims to evaluate OTX008 therapy in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day
Institut Jules Bordet
Brussels, Belgium
RECRUITINGHopital Beaujon - AP-HP
Clichy, France
RECRUITINGInstitut Claudius Regaud
Toulouse, France
RECRUITINGDose Limiting Toxicity
Dose Limiting Toxicity (DLT) will be assessed during the first 21 days (3 weeks)of OTX008 treatment in each patient to determine Recommended Dose (RD)
Time frame: up to 3 weeks of OTX008 treatment
Pharmacokinetics (PK)
OTX008 plasma concentration will be assessed at days 1, 2 and 22 of OTX008 treatment to determine PK profile of OTX008. Following parameters will be used: Trough (Cmin) and peak (Cmax) of OTX008 concentrations, Tmax, t1/2, steady state, total clearance, AUC (Area Under Curve)
Time frame: Days 1, 2 and 22 of OTX008 treatment
Pharmacodynamics (PD)
Following parameter will be measured: plasma levels of galectin-1
Time frame: Days 1 and 22 of OTX008 treatment
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