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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT03102320

Run by

Bayer

People needed

173

Starts

2017-05-26

Expected to finish

2021-07-26

Last updated by the study team

2022-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Stanford Health Care — Stanford, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• Ochsner Medical Center - New Orleans — New Orleans, Louisiana, United States
• National Cancer Institute - Maryland — Bethesda, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Farmington Hills, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Oncology, PA — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Blacktown Cancer & Haematology Centre — Blacktown, New South Wales, Australia
• Mid North Coast Cancer Institute — Coffs Harbour, New South Wales, Australia
• Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia
• Northern Cancer Institute — St Leonards, New South Wales, Australia
• Flinders Medical Centre — Adelaide, South Australia, Australia
• Epworth HealthCare — Richmond, Victoria, Australia
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
• St John of God Healthcare — Subiaco, Western Australia, Australia
• Hôpital Erasme/Erasmus Ziekenhuis — Bruxelles - Brussel, Belgium
• UZ Antwerpen — Edegem, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• CHU de Liège — Liège, Belgium
• Mayo Clinic Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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