Trial Condition(s):

Neoplasms

Phase 1b multi-indication study of anetumab ravtansine in mesothelin expressing advanced solid tumors (ARCS-Multi)

Bayer Identifier:

15834

ClinicalTrials.gov Identifier:

NCT03102320

EudraCT Number:

2016-004002-33

Study Completed

Trial Purpose

The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

Inclusion Criteria
- Availability of tumor tissue for mesothelin expression testing and for further biomarker analysis
- Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
- At least one measurable lesion according to  Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria
- Adequate bone marrow, liver, renal and coagulation function
- Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
- Exposure to more than one prior anti-tubulin/microtubule agent 
- Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
- Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
- Contraindication to both CT and MRI contrast agents
- Active hepatitis B or C infection
- Pregnant or breast-feeding patients  
- Tumor type specific exclusion criteria

Trial Summary

Enrollment Goal
173
Trial Dates
black-arrow
Phase
1
Could I receive a placebo?
No
Products
Anetumab ravtansine (BAY94-9343)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

MedStar Georgetown University Hospital

Washington, United States, 20007

Status
Completed
 
Locations

National Cancer Institute - Maryland

Bethesda, United States, 20892

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119228

Status
Completed
 
Locations

National Cancer Center Singapore

Singapore, Singapore, 169610

Status
Completed
 
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Centro Integral Oncológico Clara Campal

Madrid, Spain, 28050

Status
Completed
 
Locations

Hospital Ramón y Cajal | Oncología

Madrid, Spain, 28034

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Mayo Clinic Hospital

Phoenix, United States, 85054-4502

Status
Completed
 
Locations

Vanderbilt University Medical Center

Nashville, United States, 37232

Status
Completed
 
Locations

Blacktown Cancer & Haematology Centre

Blacktown, Australia, 2148

Status
Completed
 
Locations

St John of God Healthcare

Subiaco, Australia, 6008

Status
Completed
 
Locations

Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

Status
Completed
 
Locations

Kinghorn Cancer Centre

Darlinghurst, Australia, 2010

Status
Completed
 
Locations

Hopital Jean Minjoz

BESANCON, France, 25030

Status
Completed
 
Locations

Hôpital Henri Mondor

CRETEIL, France, 94010

Status
Completed
 
Locations

Centre Oscar Lambret - Lille

LILLE CEDEX, France, 59020

Status
Completed
 
Locations

Centre Hospitalier Lyon Sud

PIERRE BENITE, France, 69495

Status
Completed
 
Locations

C.H.U. Timone

Marseille, France, 13385

Status
Completed
 
Locations

Centre René Gauducheau

Nantes, France, 44805

Status
Completed
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Completed
 
Locations

Epworth HealthCare

Richmond, Australia, 3122

Status
Completed
 
Locations

Mid North Coast Cancer Institute

Coffs Harbour, Australia, 2450

Status
Completed
 
Locations

Indiana University School of Medicine

Indianapolis, United States, 46202

Status
Completed
 
Locations

Northern Cancer Institute

St Leonards, Australia, 2065

Status
Completed
 
Locations

Flinders Medical Centre

Adelaide, Australia, 5042

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Princess Margaret Cancer Centre - UHN

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Hôpital Pontchaillou

RENNES CEDEX, France, 35033

Status
Completed
 
Locations

Centre Eugène Marquis - Rennes Cedex

RENNES CEDEX, France, 35062

Status
Completed
 
Locations

Nederlands Kanker Instituut

AMSTERDAM, Netherlands, 1066 CX

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 69008

Status
Completed
 
Locations

Kantonsspital Graubünden

Chur, Switzerland, 7000

Status
Completed
 
Locations

Ospedale Regionale Bellinzona

Bellinzona, Switzerland, 6500

Status
Completed
 
Locations

Institut Gustave Roussy

VILLEJUIF CEDEX, France, 94805

Status
Completed
 
Locations

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

Milano, Italy, 20089

Status
Completed
 
Locations

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

Bologna, Italy, 40138

Status
Completed
 
Locations

ASST Grande Ospedale Metropolitano Niguarda

Milano, Italy, 20162

Status
Completed
 
Locations

A.O.U. di Modena - Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milano, Italy, 20133

Status
Completed
 
Locations

A.O.U.I. Verona

Verona, Italy, 37134

Status
Completed
 
Locations

Hôpital de la Milétrie

POITIERS cedex, France, 86021

Status
Completed
 
Locations

Centre Antoine Lacassagne

NICE CEDEX 2, France, 06102

Status
Completed
 
Locations

Barbara Ann Karmanos Cancer Institute

Farmington Hills, United States, 48334

Status
Completed
 
Locations

Stanford Health Care

Stanford, United States, 94305

Status
Completed
 
Locations

Ochsner Medical Center - New Orleans

New Orleans, United States, 70121

Status
Completed
 
Locations

University of Southern California

Los Angeles, United States, 90033

Status
Completed
 
Locations

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 06351

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 03080

Status
Completed
 
Locations

Guy’s Hospital

London, United Kingdom, SE1 9RT

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

Belfast City Hospital

Belfast, United Kingdom, BT12 7AB

Status
Completed
 
Locations

Hospital Universitario Quirón de Madrid

Pozuelo de Alarcón, Spain, 28223

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Hospital General Universitario Gregorio Marañón | Oncología

Madrid, Spain, 28007

Status
Completed
 
Locations

Texas Oncology, PA

Dallas, United States, 75246

Status
Completed
 
Locations

McGill University Health Center

Montreal, Canada, H4A 3J1

Status
Completed
 
Locations

Maastricht UMC

MAASTRICHT, Netherlands, 6229 HX

Status
Completed
 

Trial Design