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

Status: Active

Description

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.

Eligibility Criteria

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

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Jessica Levano
Phone: 323-783-3011
Email: jessica.s.levano@kp.org
Palo Alto
Stanford Cancer Institute Palo Alto
Status: Temporarily closed to accrual
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Aaron John Spittler
Phone: 317-274-0771
Email: ajspittl@iupui.edu

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: Active
Contact: Arun Rajan
Phone: 240-760-6236
Email: rajana@mail.nih.gov

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Approved
Name Not Available
Detroit
Wayne State University / Karmanos Cancer Institute
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Bayer Corporation

Trial IDs

Primary ID 15834
Secondary IDs NCI-2017-01221, 2016-004002-33
Clinicaltrials.gov ID NCT03102320