W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers. The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.
This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
316
Administered once every 2 weeks
Administered every 3 weeks
Administered according to the recommended dose for expansion
IUCT
Toulouse, France
IGR
Villejuif, France
VHIO
Barcelona, Spain
Incidence of Specific Adverse Events
Identification of Dose-limiting toxicities
Time frame: 28 days
Incidence of Specific Adverse Events
Identification of Dose-limiting toxicities
Time frame: From first administration up to 63 days
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