A Trial of a new drug to Treat Patients With Advanced or Metastatic Solid Cancer Tumors (Ulysse)
A Trial of a new drug to Treat Patients With Advanced or Metastatic Solid Cancer Tumors (Ulysse)
Phase I/II open label dose escalation and dose expansion study of intravenous infusion of W0101, an antibody-drug conjugate, in patients with advanced or metastatic solid tumors. International, multicenter, open label study.
Brief summary
The objective of this trial is to evaluate the tolerance and the activity of an experimental treatment (called W0101) against solid cancer tumors at an advanced stage of disease or which have spread to distant organs beyond the tumor’s initial site (metastases).
This is the first time this treatment is tested in humans.
There are two parts in this trial:
- Part /Phase I (dose escalation): to determine the best-tolerated dose as well as the most adequate administration schedule
- Part/Phase II: to assess the treatment activity at the selected dose and schedule, which has been determined during phase I
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