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.

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Status
Status :
Active
Type of study
Phase I / II
Min. Age
18
Years old
Max. Age
-
Gender
All

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

Therapeutic area :
Oncology
Disease :
Advanced or metastatic solid cancer tumors
Study medication :
W0101 (lonigutamab ugodotin)
Phase : Phase I / II
Start Date :
24 November 2017
End Date / Planned study Completion Date :
04 October 2021
Study ID : W00101IV101
EudraCT/CTIS number : 2017-001842-82
CT.gov Number : NCT03316638
Countries :
France
Spain

Find out where the clinical trial is conducted

1

Vall d'Hebron

Passéo Vall d'Hébron 119-129
08035 Barcelona
Spain

2

Institut Catala Oncologia

Gran Via 199-203
89086 Lhospitalet de llobregat
Spain

3

IOR Hospital Dexeus Barcelona

Carrer de Sabino Arana 5
80267 Barcelona
Spain

4

Hospital Universitario 12 de Octubre

Avda. de Cordoba sn
28041 Madrid
Spain

5

Hospital Ruber Internacional

38, Calle de la Maso 2nd floor
28034 Madrid
Spain

6

Biomedical Research institute INCLIVA

Av. Menndez Pelayo 4 accesorio
46010 Valencia
Spain

7

Institut de cancerologie de l'ouest

Bld J. Monod
44360 Saint herblain
France

8

Institut Gustave ROUSSY

39 rue Camille DESMOULINS IGR
94805 Villejuif
France

9

Institut Curie

Clinical Trial Unit INSERM U900 26, rue de l'Ulm
75248 Paris
France

10

Institut Bergoni

229 Cr de l'Argonne
33000 Bordeaux
France

11

Institut Claudius Regaud (IUCT-O)

1, avenue Irène Joliot Curie
31059 Toulouse
France

12

INSTITUT PAOLI CALMETTES

232 boulevard sainte marguerite
13273 Marseille
France

13

Gustave Roussy (IGR)

114, rue Edouard Vaillant
94805 Villejuif
France

14

Hopital Saint Louis

1 Avenue Claude Vellefaux
75010 Paris
France

15

Centre Eugene Marquis

av Bataille Flandres Dunkerque
35042 Rennes
France

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16

Centre Francois Baclesse

3 avenue du general harris
14000 Caen
France

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17

CENTRE LEON BERARD

28 rue Laennec
69373 Lyon
France

18

CHU UCL Namur Site Sainte Elisabeth

Place Louise Godin 15
5000 Namur
Belgium

19

Cliniques universitaires Saint-Luc

avenue Hippocrate 10
1200 Brussels
Belgium

20

Antwerp University Hospital

Drie Eikenstraat 655
2650 Edegem
Belgium

Last update at : 15 November 2023

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