Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

May 26, 2017

Primary Completion Date

September 16, 2020

Study Completion Date

July 26, 2021

Conditions
Neoplasms
Interventions
DRUG

Cisplatin

Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle

DRUG

Anetumab ravtansine (BAY94-9343)

Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered

Trial Locations (72)

1070

Hôpital Erasme/Erasmus Ziekenhuis, Bruxelles - Brussel

2010

Kinghorn Cancer Centre, Darlinghurst

2065

Northern Cancer Institute, St Leonards

2148

Blacktown Cancer & Haematology Centre, Blacktown

2450

Mid North Coast Cancer Institute, Coffs Harbour

2650

UZ Antwerpen, Edegem

3000

UZ Leuven Gasthuisberg, Leuven

3122

Epworth HealthCare, Richmond

4000

CHU de Liège, Liège

5042

Flinders Medical Centre, Adelaide

6008

St John of God Healthcare, Subiaco

6009

Sir Charles Gairdner Hospital, Nedlands

6500

Ospedale Regionale Bellinzona, Bellinzona

7000

Kantonsspital Graubünden, Chur

13385

C.H.U. Timone, Marseille

20007

MedStar Georgetown University Hospital, Washington D.C.

20089

Istituto Clinico Humanitas - Humanitas Mirasole S.p.A., Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20892

National Cancer Institute - Maryland, Bethesda

25030

Hopital Jean Minjoz, Besançon

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncológico Clara Campal, Madrid

28223

Hospital Universitario Quirón de Madrid, Pozuelo de Alarcón

29010

Hospital Virgen de la Victoria, Málaga

35033

Hôpital Pontchaillou, Rennes

35062

Centre Eugène Marquis - Rennes Cedex, Rennes

37134

A.O.U.I. Verona, Verona

37232

Vanderbilt University Medical Center, Nashville

40138

A.O.U. di Bologna Policlinico S.Orsola Malpighi, Bologna

41124

A.O.U. di Modena - Policlinico, Modena

44805

Centre René Gauducheau, Nantes

46202

Indiana University School of Medicine, Indianapolis

48334

Barbara Ann Karmanos Cancer Institute, Farmington Hills

55905

Mayo Clinic - Rochester, Rochester

59020

Centre Oscar Lambret - Lille, Lille

63110

Washington University School of Medicine, St Louis

69008

Centre Léon Bérard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70121

Ochsner Medical Center - New Orleans, New Orleans

75246

Texas Oncology, PA, Dallas

77030

University of Texas MD Anderson Cancer Center, Houston

86021

Hôpital de la Milétrie, Poitiers

90033

University of Southern California, Los Angeles

94010

Hôpital Henri Mondor, Créteil

94305

Stanford Health Care, Stanford

94805

Institut Gustave Roussy, Villejuif

119228

National University Hospital, Singapore

169610

National Cancer Center Singapore, Singapore

85054-4502

Mayo Clinic Hospital, Phoenix

T6G 1Z2

Cross Cancer Institute, Edmonton

M5G 2M9

Princess Margaret Cancer Centre - UHN, Toronto

H3T 1E2

Sir Mortimer B. Davis Jewish General Hospital, Montreal

H4A 3J1

McGill University Health Center, Montreal

06102

Centre Antoine Lacassagne, Nice

1066 CX

Nederlands Kanker Instituut, Amsterdam

6229 HX

Maastricht UMC, Maastricht

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08003

Hospital del Mar, Barcelona

08035

Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial de Barcelona, Barcelona

Unknown

"Hospital General Universitario Gregorio Marañón , Oncología"

"Hospital Ramón y Cajal , Oncología"

LE1 5WW

Leicester Royal Infirmary, Leicester

BT12 7AB

Belfast City Hospital, Belfast

SM2 5PT

Royal Marsden NHS Trust (Surrey), Sutton

SE1 9RT

Guy's Hospital, London

SW3 6JJ

Royal Marsden Hospital (London), London

M20 4BX

Christie Hospital, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

ImmunoGen, Inc.

INDUSTRY

collaborator

MorphoSys AG

INDUSTRY

lead

Bayer

INDUSTRY