NCT03316638

A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	W0101 - Cohort A1	Administered once every 2 weeks
DRUG	W0101 - Cohort A2	Administered every 3 weeks
DRUG	W0101 - Expansion Phase	Administered according to the recommended dose for expansion

Timeline

• Start date: 2017-11-24
• Primary completion: 2021-10-30
• Completion: 2022-07-05
• First posted: 2017-10-20
• Last updated: 2024-12-10

Locations

3 sites across 2 countries: France, Spain